Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-30 (of 125 Records) |
Query Trace: Clarke T[original query] |
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Investigation of presumptive HIV transmission associated with receipt of platelet-rich plasma microneedling facials at a spa among former spa clients - New Mexico, 2018-2023
Stadelman-Behar AM , Gehre MN , Atallah L , Clarke T , Leonso AA , Jojola F , Zheng H , Jia H , Lyss SB , Switzer WM , Grytdal SP , Durham M , Salas NM , Sievers M , Smelser C . MMWR Morb Mortal Wkly Rep 2024 73 (16) 372-376 HIV transmitted through cosmetic injection services via contaminated blood has not been previously documented. During summer 2018, the New Mexico Department of Health (NMDOH) was notified of a diagnosis of HIV infection in a woman with no known HIV risk factors who reported exposure to needles from cosmetic platelet-rich plasma microneedling facials (vampire facials) received at a spa in spring 2018. An investigation of the spa's services began in summer 2018, and NMDOH and CDC identified four former spa clients, and one sexual partner of a spa client, all of whom received HIV infection diagnoses during 2018-2023, despite low reported behavioral risks associated with HIV acquisition. Nucleotide sequence analysis revealed highly similar HIV strains among all cases. Although transmission of HIV via unsterile injection practices is a known risk, determining novel routes of HIV transmission among persons with no known HIV risk factors is important. This investigation identified an HIV cluster associated with receipt of cosmetic injection services at an unlicensed facility that did not follow recommended infection control procedures or maintain client records. Requiring adequate infection control practices and maintenance of client records at spa facilities offering cosmetic injection services can help prevent the transmission of HIV and other bloodborne pathogens and ensure adequate traceback and notification in the event of adverse clinical outcomes, respectively. |
Recommendations for use of p16/Ki67 dual stain for management of individuals testing positive for human papillomavirus
Clarke MA , Wentzensen N , Perkins RB , Garcia F , Arrindell D , Chelmow D , Cheung LC , Darragh TM , Egemen D , Guido R , Huh W , Locke A , Lorey TS , Nayar R , Risley C , Saslow D , Smith RA , Unger ER , Massad LS . J Low Genit Tract Dis 2024 OBJECTIVES: The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for dual stain (DS) testing with CINtec PLUS Cytology for use of DS to triage high-risk human papillomavirus (HPV)-positive results. METHODS: Risks of cervical intraepithelial neoplasia grade 3 or worse were calculated according to DS results among individuals testing HPV-positive using data from the Kaiser Permanente Northern California cohort and the STudying Risk to Improve DisparitiES study in Mississippi. Management recommendations were based on clinical action thresholds developed for the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines. Resource usage metrics were calculated to support decision-making. Risk estimates in relation to clinical action thresholds were reviewed and used as the basis for draft recommendations. After an open comment period, recommendations were finalized and ratified through a vote by the Consensus Stakeholder Group. RESULTS: For triage of positive HPV results from screening with primary HPV testing (with or without genotyping) or with cytology cotesting, colposcopy is recommended for individuals testing DS-positive. One-year follow-up with HPV-based testing is recommended for individuals testing DS-negative, except for HPV16- and HPV18-positive results, or high-grade cytology in cotesting, where immediate colposcopy referral is recommended. Risk estimates were similar between the Kaiser Permanente Northern California and STudying Risk to Improve DisparitiES populations. In general, resource usage metrics suggest that compared with cytology, DS requires fewer colposcopies and detects cervical intraepithelial neoplasia grade 3 or worse earlier. CONCLUSIONS: Dual stain testing with CINtec PLUS Cytology is acceptable for triage of HPV-positive test results. Risk estimates are portable across different populations. |
Enduring consensus guidelines for cervical cancer screening and management: Introduction to the scope and process
Wentzensen N , Garcia F , Clarke MA , Massad LS , Cheung LC , Egemen D , Guido R , Huh W , Saslow D , Smith RA , Unger ER , Perkins RB . J Low Genit Tract Dis 2024 OBJECTIVES: The Enduring Consensus Cervical Cancer Screening and Management Guidelines (Enduring Guidelines) effort is a standing committee to continuously evaluate new technologies and approaches to cervical cancer screening, management, and surveillance. METHODS AND RESULTS: The Enduring Guidelines process will selectively incorporate new technologies and approaches with adequate supportive data to more effectively improve cancer prevention for high-risk individuals and decrease unnecessary procedures in low-risk individuals. This manuscript describes the structure, process, and methods of the Enduring Guidelines effort. Using systematic literature reviews and primary data sources, risk of precancer will be estimated and recommendations will be made based on risk estimates in the context of established risk-based clinical action thresholds. The Enduring Guidelines process will consider health equity and health disparities by assuring inclusion of diverse populations in the evidence review and risk assessment and by developing recommendations that provide a choice of well-validated strategies that can be adapted to different settings. CONCLUSIONS: The Enduring Guidelines process will allow updating existing cervical cancer screening and management guidelines rapidly when new technologies are approved or new scientific evidence becomes available. |
Association between social vulnerability and SARS-CoV-2 seroprevalence in specimens collected from commercial laboratories, United States, September 2021-February 2022
Benoit TJ , Kim Y , Deng Y , Li Z , Harding L , Wiegand R , Deng X , Jones JM , Ronaldo I , Clarke KEN . Public Health Rep 2024 333549231223140 OBJECTIVE: We conducted a national US study of SARS-CoV-2 seroprevalence by Social Vulnerability Index (SVI) that included pediatric data and compared the Delta and Omicron periods during the COVID-19 pandemic. The objective of the current study was to assess the association between SVI and seroprevalence of infection-induced SARS-CoV-2 antibodies by period (Delta vs Omicron) and age group. METHODS: We used results of infection-induced SARS-CoV-2 antibody assays of clinical sera specimens (N = 406 469) from 50 US states from September 2021 through February 2022 to estimate seroprevalence overall and by county SVI tercile. Bivariate analyses and multilevel logistic regression models assessed the association of seropositivity with SVI and its themes by age group (0-17, ≥18 y) and period (Delta: September-November 2021; Omicron: December 2021-February 2022). RESULTS: Aggregate infection-induced SARS-CoV-2 antibody seroprevalence increased at all 3 SVI levels; it ranged from 25.8% to 33.5% in September 2021 and from 53.1% to 63.5% in February 2022. Of the 4 SVI themes, socioeconomic status had the strongest association with seroprevalence. During the Delta period, we found significantly more infections per reported case among people living in a county with high SVI (odds ratio [OR] = 2.76; 95% CI, 2.31-3.21) than in a county with low SVI (OR = 1.65; 95% CI, 1.33-1.97); we found no significant difference during the Omicron period. Otherwise, findings were consistent across subanalyses by age group and period. CONCLUSIONS: Among both children and adults, and during both the Delta and Omicron periods, counties with high SVI had significantly higher SARS-CoV-2 antibody seroprevalence than counties with low SVI did. These disparities reinforce SVI's value in identifying communities that need tailored prevention efforts during public health emergencies and resources to recover from their effects. |
A qualitative assessment of cleaning and hand hygiene practices at shelters serving people experiencing homelessness during the COVID-19 pandemic, Atlanta, GA - May-June, 2020
Besrat BN , Mosites E , Montgomery MP , Garcia-Williams AG , Trautner E , Clarke KEN , Marshall B , Vassell C , Rutt C , Jones SL . BMC Public Health 2024 24 (1) 247 BACKGROUND: Cleaning practices and hand hygiene are important behaviors to prevent and control the spread of infectious disease, especially in congregate settings. This project explored hygiene- and cleaning-related experiences in shelters serving people experiencing homelessness (PEH) during May-June 2020 of the COVID-19 pandemic. METHODS: We conducted qualitative, in-depth interviews by phone with 22 staff from six shelters in Atlanta, Georgia. The interview guide included questions about cleaning routines, cleaning barriers and facilitators, cleaning promotion, hand hygiene promotion, and hand hygiene barriers and facilitators. We analyzed interview transcripts using thematic analysis. RESULTS: Multiple individuals, such as shelter individuals (clients), volunteers, and staff, played a role in shelter cleaning. Staff reported engaging in frequent hand hygiene and cleaning practices. Barriers to cleaning included staffing shortages and access to cleaning supplies. Staff reported barriers (e.g., differing perceptions of cleanliness) for clients who were often involved in cleaning activities. Barriers to hand hygiene included limited time to wash hands, forgetting, and inconvenient handwashing facilities. Specific guidance about when and how to clean, and what supplies to use, were requested. CONCLUSION: During the early months of the COVID-19 pandemic, shelters serving PEH in the Atlanta-metro area needed resources and support to ensure sufficient staffing and supplies for cleaning activities. As part of future pandemic planning and outbreak prevention efforts, shelters serving PEH could benefit from specific guidance and training materials on cleaning and hand hygiene practices. |
Tolerability, safety, and immunogenicity of the novel oral polio vaccine type 2 in children aged 6 weeks to 59 months in an outbreak response campaign in The Gambia: an observational cohort study
Bashorun AO , Kotei L , Jawla O , Jallow AF , Saidy AJ , Kinteh MA , Kujabi A , Jobarteh T , Kanu FJ , Donkor SA , Ezeani E , Fofana S , Njie M , Ceesay L , Jafri B , Williams A , Jeffries D , Kotanmi B , Mainou BA , Ooko M , Clarke E . Lancet Infect Dis 2024 BACKGROUND: Novel oral polio vaccine type 2 (nOPV2) has been used to interrupt circulating vaccine-derived poliovirus type 2 outbreaks following its WHO emergency use listing. This study reports data on the safety and immunogenicity of nOPV2 over two rounds of a campaign in The Gambia. METHODS: This observational cohort study collected baseline symptoms (vomiting, diarrhoea, irritability, reduced feeding, and reduced activity) and axillary temperature from children aged 6 weeks to 59 months in The Gambia before a series of two rounds of a nOPV2 campaign that took place on Nov 20-26, 2021, and March 19-22, 2022. Serum and stool samples were collected from a subset of the participants. The same symptoms were re-assessed during the week following each dose of nOPV2. Stool samples were collected on days 7 and 28, and serum was collected on day 28 following each dose. Adverse events, including adverse events of special interest, were documented for 28 days after each campaign round. Serum neutralising antibodies were measured by microneutralisation assay, and stool poliovirus excretion was measured by real-time RT-PCR. FINDINGS: Of the 5635 children eligible for the study, 5504 (97·7%) received at least one dose of nOPV2. There was no increase in axillary temperature or in any of the baseline symptoms following either rounds of the campaigns. There were no adverse events of special interest and no other safety signals of concern. Poliovirus type 2 seroconversion rates were 70% (95% CI 62 to 78; 87 of 124 children) following one dose of nOPV2 and 91% (85 to 95; 113 of 124 children) following two doses. Poliovirus excretion on day 7 was lower after the second round (162 of 459 samples; 35·3%, 95% CI 31·1 to 39·8) than after the first round (292 of 658 samples; 44·4%, 40·6 to 48·2) of the campaign (difference -9·1%; 95% CI -14·8 to -3·3), showing the induction of mucosal immunity. INTERPRETATION: In a campaign in west Africa, nOPV2 was well tolerated and safe. High rates of seroconversion and evidence of mucosal immunity support the licensure and WHO prequalification of this vaccine. FUNDING: Bill & Melinda Gates Foundation. |
Considerations for defining homelessness in public health data collection
Meehan AA , Waddell CJ , Marx GE , Clarke KEN , Bratcher A , Montgomery MP , Marcus R , Ramirez V , Mosites E . Public Health Rep 2023 333549231215850 Public health problems cannot be addressed without timely and accurate data. However, data that provide insight into populations that may be at disproportionate risk for disease, including people experiencing homelessness, are insufficiently captured. Although the associations between homelessness and disease have been well documented,1-6 data on housing status are not universally or consistently collected in routine public health data.7 Improving collection of data on housing status in public health data collection efforts is necessary to address health disparities among people experiencing homelessness and advance health equity research and practice. | Collecting data related to homelessness and disease is complicated for several reasons, but one of the most salient reasons is that defining homelessness is challenging. Several federal agencies use their own definitions to identify people who might be eligible for assistance programs, creating confusion about which definition should be used for public health purposes. In addition, definitions of homelessness at federal agencies have changed over time, further complicating the collection of homelessness data. The US Department of Housing and Urban Development (HUD) defines homelessness as lacking a fixed, regular, and adequate nighttime residence8; this definition includes both people with a primary nighttime residence of a public or private place not meant for human habitation (eg, cars, parks, public spaces, abandoned buildings) and people residing in temporary shelters (eg, emergency homeless shelter, transitional housing). The US Department of Education (DOE) uses a broader lens, defining homelessness to include school-aged children whose housing situation meets the HUD criteria for homelessness while also including those who share housing with other people by doubling up or couch surfing; those who live in motels, hotels, or trailer parks; and those who are abandoned at hospitals.9 |
Who gets sick from COVID-19 Sociodemographic correlates of severe adult health outcomes during Alpha- and Delta-variant predominant periods, 9/2020-11/2021
Wei SC , Freeman D , Himschoot A , Clarke KEN , Van Dyke ME , Adjemian J , Ahmad FB , Benoit TJ , Berney K , Gundlapalli AV , Hall AJ , Havers F , Henley SJ , Hilton C , Johns D , Opsomer JD , Pham HT , Stuckey MJ , Taylor CA , Jones JM . J Infect Dis 2023 BACKGROUND: Because COVID-19 case data do not capture most SARS-CoV-2 infections, the actual risk of severe disease and death per infection is unknown. Integrating sociodemographic data into analysis can show consequential health disparities. METHODS: Data from September 2020--November 2021 from six national surveillance systems in matched geographical areas were merged and analyzed to estimate numbers of COVID-19-associated cases, emergency department visits, and deaths per 100,000 infections. Relative risks of outcomes per infection were compared by sociodemographic factors in a dataset including 1,490 counties from 50 states and the District of Columbia, covering 71% of the US population. RESULTS: Per infection with SARS-CoV-2, COVID-19-related morbidity and mortality were higher among non-Hispanic American Indian and Alaska Native persons, non-Hispanic Black persons, and Hispanic or Latino persons compared with non-Hispanic White persons, males compared with females, older persons compared with younger, persons in more socially vulnerable counties compared with less, persons in large central metro areas compared with rural areas, and persons in the South compared with the Northeast. DISCUSSION: Meaningful disparities in COVID-19 morbidity and mortality per infection were associated with sociodemography and geography. Addressing these disparities could have helped prevent the loss of tens of thousands of lives. |
Racial, ethnic, sex, and age differences in COVID-19 cases, hospitalizations, and deaths among incarcerated people and staff in correctional facilities in six jurisdictions, United States, March-July 2020
D'Inverno AS , Myles RL , Jamison CR , Williams SP , Hagan LM , Handanagic S , Lambert LA , Clarke KEN , Allen J , Beard O , Dusseau C , Feldman R , Huebsch R , Hutchinson J , Kall D , King-Mohr J , Long M , McClure ES , Meddaugh P , Pontones P , Rose J , Sredl M , VonBank B , Zipprich J . J Racial Ethn Health Disparities 2023 OBJECTIVES: To examine disparities by sex, age group, and race and ethnicity in COVID-19 confirmed cases, hospitalizations, and deaths among incarcerated people and staff in correctional facilities. METHODS: Six U.S. jurisdictions reported data on COVID-19 confirmed cases, hospitalizations, and deaths stratified by sex, age group, and race and ethnicity for incarcerated people and staff in correctional facilities during March 1- July 31, 2020. We calculated incidence rates and rate ratios (RR) and absolute rate differences (RD) by sex, age group, and race and ethnicity, and made comparisons to the U.S. general population. RESULTS: Compared with the U.S. general population, incarcerated people and staff had higher COVID-19 case incidence (RR = 14.1, 95% CI = 13.9-14.3; RD = 6,692.2, CI = 6,598.8-6,785.5; RR = 6.0, CI = 5.7-6.3; RD = 2523.0, CI = 2368.1-2677.9, respectively); incarcerated people also had higher rates of COVID-19-related deaths (RR = 1.6, CI = 1.4-1.9; RD = 23.6, CI = 14.9-32.2). Rates of COVID-19 cases, hospitalizations, and deaths among incarcerated people and corrections staff differed by sex, age group, and race and ethnicity. The COVID-19 hospitalization (RR = 0.9, CI = 0.8-1.0; RD = -48.0, CI = -79.1- -16.8) and death rates (RR = 0.8, CI = 0.6-1.0; RD = -11.8, CI = -23.5- -0.1) for Black incarcerated people were lower than those for Black people in the general population. COVID-19 case incidence, hospitalizations, and deaths were higher among older incarcerated people, but not among staff. CONCLUSIONS: With a few exceptions, living or working in a correctional setting was associated with higher risk of COVID-19 infection and resulted in worse health outcomes compared with the general population; however, Black incarcerated people fared better than their U.S. general population counterparts. |
A randomized controlled trial of antibody response to 2019-20 cell-based inactivated and egg-based live attenuated influenza vaccines in children and young adults (preprint)
Williams KV , Zhai B , Alcorn JF , Patricia Nowalk M , Levine MZ , Kim SS , Flannery B , Moehling Geffel K , Jaber Merranko A , Nagg JP , Collins M , Susick M , Clarke KS , Zimmerman RK , Martin JM . medRxiv 2021 2021.09.02.21263043 Background Hemagglutination inhibition (HAI) titers to the live-attenuated influenza vaccine (LAIV4) are typically lower than its counterpart egg-based inactivated influenza vaccines (IIV). Similar comparisons have not been made between LAIV4 and the 4-strain, cell-culture inactivated influenza vaccine (ccIIV4). We compared healthy children and young adult HAI titers against the 2019-2020 LAIV4 and ccIIV4.Methods Participants aged 4-21 years were randomized 1:1 to receive ccIIV4 (n =100) or LAIV4 (n=98). Blood was drawn prevaccination and on day 28 (21-35) post vaccination. HAI assays against egg-grown A/H1N1, A/H3N2, both vaccine B strains and cell-grown A/H3N2 antigens were conducted. Outcomes were geometric mean titers (GMT) and geometric mean fold rise (GMFR) in titers.Results GMTs to A/H1N1, A/H3N2 and B/Victoria increased following both ccIIV and LAIV and to B/Yamagata following ccIIV (p<0.05). The GMFR range was 2.4-3.0 times higher for ccIIV4 than for LAIV4 (p<0.001). Within vaccine types, egg-grown A/H3N2 GMTs were higher (p<0.05) than cell-grown GMTs [ccIIV4 day 28: egg=205 (95% CI: 178-237); cell=136 (95% CI:113-165); LAIV4 day 28: egg=96 (95% CI: 83-112); cell=63 (95% CI: 58-74)]. The GMFR to A/H3N2 cell-grown and egg-grown antigens were similar. Pre-vaccination titers inversely predicted GMFR.Conclusion The HAI response to ccIIV4 was greater than LAIV4 in this study of mostly older children, and day 0 HAI titers inversely predicted GMFR for both vaccines. For both vaccines, the A/H3N2 cell-grown antigen levels were lower than egg-grown, but the GMFR for cell-grown and egg-grown did not differ significantly within vaccine type.Clinical Trials No NCT03982069Competing Interest StatementConflict of Interest: RKZ has received funding by Sanofi for an unrelated study. MPN has research funding from Merck & Co., Inc. for an unrelated study. JMM has received funding from Merck, Sharp and Dohme for an unrelated study.Clinical TrialClinical Trials No.: NCT03982069Funding StatementThis work was supported by the Centers for Disease Control and Prevention (CDC) [5U01IP001035] and by National Institutes of Health (NIH) [UL1TR001857], [KL2 TR001856], and/or [TL1 TR001858]. This work represents the views of the authors and not the CDC or NIH. Pennsylvania Statewide Immunization Information System (PA-SIIS) vaccine registry was used to verify vaccination status. These data were supplied in part by the Bureau of Health Statistics & Registries, Pennsylvania Department of Health, Harrisburg, Pennsylvania. The Pennsylvania Department of Health specifically disclaims responsibility for any analyses, interpretations, or conclusions. REDCap and the Department of Biomedical Informatics grant support (Clinical and Translational Sciences Institute at the University of Pittsburgh Grant Number UL1-TR-001857). Study data were collected and managed using REDCap electronic data capture tools hosted at the University of Pittsburgh. Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:The Institutional Review Boards at the University of Pittsburgh and the Centers for Disease Control and Prevention (CDC) approved this study. Written informed consent and assent, where appropriate, were obtained from all participants and/or their parents/legal guardians prior to beginning study procedures.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field expla ning why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData can be made available upon request.HAIhemagglutination inhibition assayIIVinactivated influenza vaccineccIIV4cell-culture-based inactivated influenza vaccine quadrivalentLAIV4Egg-based live attenuated influenza vaccine quadrivalentEMRElectronic medical recordRDEReceptor-destroying enzymePBSPhosphate-buffered salineCDCCenters for Disease Control and PreventionFDAFood and Drug AdministrationGMTGeometric mean titersGMFRGeometric mean fold riseACIPAdvisory Committee on Immunization PracticePA-SIISPennsylvania Statewide Immunization Information System |
Methods for Estimation of SARS-CoV-2 Seroprevalence and Reported COVID-19 Cases in U.S. Children, August 2020—May 2021 (preprint)
Couture A , Lyons BC , Mehrotra ML , Sosa L , Ezike N , Ahmed FS , Brown CM , Yendell S , Azzam IA , Katić BJ , Cope A , Dickerson K , Stone J , Traxler LB , Dunn JR , Davis LB , Reed C , Clarke KEN , Flannery B , Charles MD . medRxiv 2021 2021.09.26.21263756 Background and Objectives Case-based surveillance of pediatric COVID-19 cases underestimates the prevalence of SARS-CoV-2 infections among children and adolescents. Our objectives were to: 1) estimate monthly SARS-CoV-2 antibody seroprevalence among children aged 0-17 years and 2) calculate ratios of SARS-CoV-2 infections to reported COVID-19 cases among children and adolescents in 14 U.S. states.Methods Using data from commercial laboratory seroprevalence surveys, we estimated monthly SARS-CoV-2 antibody seroprevalence among children aged 0-17 years from August 2020 through May 2021. Seroprevalence estimates were based on SARS-CoV-2 anti-nucleocapsid immunoassays from February to May 2021. We compared estimated numbers of children infected with SARS-CoV-2 by May 2021 to cumulative incidence of confirmed and probable COVID-19 cases from case-based surveillance, and calculated infection: case ratios by state and type of anti-SARS-CoV-2 nucleocapsid immunoassay used for seroprevalence testing.Results Analyses included 67,321 serum specimens tested for SARS-CoV-2 antibodies among children in 14 U.S. states. Estimated ratios of SARS-CoV-2 infections to reported confirmed and probable COVID-19 cases among children and adolescents varied by state and type of immunoassay, ranging from 0.8-13.3 in May 2021.Conclusions Through May 2021, the majority of children in selected states did not have detectable SARS-CoV-2 nucleocapsid antibodies. Case-based surveillance underestimated the number of children infected with SARS-CoV-2, however the predicted extent of the underestimate varied by state, immunoassay, and over time. Continued monitoring of pediatric SARS-CoV-2 antibody seroprevalence should inform prevention and vaccination strategies.Competing Interest StatementThe authors have declared no competing interest.Funding StatementFunding for this work was supported by CDC (Atlanta, Georgia).Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by Centers for Disease Control and Prevention and determined to be consistent with non human participant research activity. Informed consent was waived, as data were deidentified. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesDeidentified individual participant data will not be made available.CDCCenters of Disease Control and PreventionMIS-CMultisystem inflammatory syndrome in childrenEUAEmergency Use AuthorizationFDAU.S. Food and Drug AdministrationACIPAdvisory Committee on Immunizations PracticesNNucleocapsidSSpikeIgImmunoglobulinCIConfidence intervals |
Global emergence and population dynamics of divergent serotype 3 CC180 pneumococci (preprint)
Azarian T , Mitchell PK , Georgieva M , Thompson CM , Ghouila A , Pollard AJ , von Gottberg A , du Plessis M , Antonio M , Kwambana-Adams BA , Clarke SC , Everett D , Cornick J , Sadowy E , Hryniewicz W , Skoczynska A , Moisi JC , McGee L , Beall B , Metcalf BJ , Breiman RF , Ho PL , Reid R , O'Brien KL , Gladstone RA , Bentley SD , Hanage WP . bioRxiv 2018 314880 Streptococcus pneumoniae serotype 3 remains a significant cause of morbidity and mortality worldwide, despite inclusion in the 13-valent pneumococcal conjugate vaccine (PCV13). Serotype 3 increased in carriage since the implementation of PCV13 in the United States, while invasive disease rates remain unchanged. We investigated the persistence of serotype 3 in carriage and disease, through genomic analyses of a global sample of 301 serotype 3 isolates of the Netherlands3–31 (PMEN31) clone CC180, combined with associated patient data and PCV utilization among countries of isolate collection. We assessed phenotypic variation between dominant clades in capsule charge (zeta potential), capsular polysaccharide shedding, and susceptibility to opsonophagocytic killing, which have previously been associated with carriage duration, invasiveness, and vaccine escape. We identify a recent shift in the CC180 population attributed to a lineage termed Clade II, which was estimated by Bayesian coalescent analysis to have first appeared in 1968 [95% HPD: 1939–1989] and increased in prevalence and effective population size thereafter. Clade II isolates are divergent from the pre-PCV13 serotype 3 population in non-capsular antigenic composition, competence, and antibiotic susceptibility, the last resulting from the acquisition of a Tn916-like conjugative transposon. Differences in recombination rates among clades correlated with variations in the ATP-binding subunit of Clp protease as well as amino acid substitutions in the comCDE operon. Opsonophagocytic killing assays elucidated the low observed efficacy of PCV13 against serotype 3. Variation in PCV13 use among sampled countries was not independently correlated with the CC180 population shift; therefore, genotypic and phenotypic differences in protein antigens and, in particular, antibiotic resistance may have contributed to the increase of Clade II. Our analysis emphasizes the need for routine, representative sampling of isolates from disperse geographic regions, including historically under-sampled areas. We also highlight the value of genomics in resolving antigenic and epidemiological variations within a serotype, which may have implications for future vaccine development.Author Summary Streptococcus pneumoniae is a leading cause of bacterial pneumoniae, meningitis, and otitis media. Despite inclusion in the most recent pneumococcal conjugate vaccine, PCV13, serotype 3 remains epidemiologically important globally. We investigated the persistence of serotype 3 using whole-genome sequencing data form 301 isolates collected among 24 countries from 1993–2014. Through phylogenetic analysis, we identified three distinct lineages within a single clonal complex, CC180, and found one has recently emerged and grown in prevalence. We then compared genomic difference among lineages as well as variations in pneumococcal vaccine use among sampled countries. We found that the recently emerged lineage, termed Clade II, has a higher prevalence of antibiotic resistance compared to other lineages, diverse surface protein antigens, and a higher rate of recombination, a process by which bacteria can uptake and incorporate genetic material from its surroundings. Differences in vaccine use among sampled countries did not appear to be associated with the emergence of Clade II. We highlight the need to routine, representative sampling of bacterial isolates from diverse geographic areas and show the utility of genomic data in resolving epidemiological differences within a pathogen population. |
SARS-CoV-2 convalescent sera binding and neutralizing antibody concentrations compared with COVID-19 vaccine efficacy estimates against symptomatic infection (preprint)
Schuh AJ , Satheshkumar PS , Dietz S , Bull-Otterson L , Charles M , Edens C , Jones JM , Bajema KL , Clarke KEN , McDonald LC , Patel S , Cuffe K , Thornburg NJ , Schiffer J , Chun K , Bastidas M , Fernando M , Petropoulos CJ , Wrin T , Cai S , Adcock D , Sesok-Pizzini D , Letovsky S , Fry AM , Hall AJ , Gundlapalli AV . medRxiv 2021 26 Previous vaccine efficacy (VE) studies have estimated neutralizing and binding antibody concentrations that correlate with protection from symptomatic infection; how these estimates compare to those generated in response to SARS-CoV-2 infection is unclear. Here, we assessed quantitative neutralizing and binding antibody concentrations using standardized SARS-CoV-2 assays on 3,067 serum specimens collected during July 27, 2020-August 27, 2020 from COVID-19 unvaccinated persons with detectable anti-SARS-CoV-2 antibodies using qualitative antibody assays. Quantitative neutralizing and binding antibody concentrations were strongly positively correlated (r=0.76, p<0.0001) and were noted to be several fold lower in the unvaccinated study population as compared to published data on concentrations noted 28 days post-vaccination. In this convenience sample, ~88% of neutralizing and ~63-86% of binding antibody concentrations met or exceeded concentrations associated with 70% COVID-19 VE against symptomatic infection from published VE studies; ~30% of neutralizing and 1-14% of binding antibody concentrations met or exceeded concentrations associated with 90% COVID-19 VE. These data support observations of infection-induced immunity and current recommendations for vaccination post infection to maximize protection against symptomatic COVID-19. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Effectiveness of 2 and 3 mRNA COVID-19 Vaccines Doses against Omicron and Delta-Related Outpatient Illness among Adults, October 2021 - February 2022 (preprint)
Kim SS , Chung JR , Talbot HK , Grijalva CG , Wernli KJ , Martin ET , Monto AS , Belongia EA , McLean HQ , Gaglani M , Mamawala M , Nowalk MP , Geffel KM , Tartof SY , Florea A , Lee JS , Tenforde MW , Patel MM , Flannery B , Bentz ML , Burgin A , Burroughs M , Davis ML , Howard D , Lacek K , Madden JC , Nobles S , Padilla J , Sheth M , Arroliga A , Beeram M , Dunnigan K , Ettlinger J , Graves A , Hoffman E , Jatla M , McKillop A , Murthy K , Mutnal M , Priest E , Raiyani C , Rao A , Requenez L , Settele N , Smith M , Stone K , Thomas J , Volz M , Walker K , Zayed M , Annan E , Daley P , Kniss K , Merced-Morales A , Ayala E , Amundsen B , Aragones M , Calderon R , Hong V , Jimenez G , Kim J , Ku J , Lewin B , McDaniel A , Reyes A , Shaw S , Takhar H , Torres A , Burganowski R , Kiniry E , Moser KA , Nguyen M , Park S , Wellwood S , Wickersham B , Alvarado-Batres J , Benz S , Berger H , Bissonnette A , Blake J , Boese K , Botten E , Boyer J , Braun M , Breu B , Burbey G , Cravillion C , Delgadillo C , Donnerbauer A , Dziedzic T , Eddy J , Edgren H , Ermeling A , Ewert K , Fehrenbach C , Fernandez R , Frome W , Guzinski S , Heeren L , Herda D , Hertel M , Heuer G , Higdon E , Ivacic L , Jepsen L , Kaiser S , Karl J , Keffer B , King J , Koepel TK , Kohl S , Kohn S , Kohnhorst D , Kronholm E , Le T , Lemieux A , Marcis C , Maronde M , McCready I , McGreevey K , Meece J , Mehta N , Miesbauer D , Moon V , Moran J , Nikolai C , Olson B , Olstadt J , Ott L , Pan N , Pike C , Polacek D , Presson M , Price N , Rayburn C , Reardon C , Rotar M , Rottscheit C , Salzwedel J , Saucedo J , Scheffen K , Schug C , Seyfert K , Shrestha R , Slenczka A , Stefanski E , Strupp M , Tichenor M , Watkins L , Zachow A , Zimmerman B , Bauer S , Beney K , Cheng CK , Faraj N , Getz A , Grissom M , Groesbeck M , Harrison S , Henson K , Jermanus K , Johnson E , Kaniclides A , Kimberly A , Lamerato LE , Lauring A , Lehmann-Wandell R , McSpadden EJ , Nabors L , Truscon R , Balasubramani GK , Bear T , Bobeck J , Bowser E , Clarke K , Clarke LG , Dauer K , Deluca C , Dierks B , Haynes L , Hickey R , Johnson M , Jonsson A , Luosang N , McKown L , Peterson A , Phaturos D , Rectenwald A , Sax TM , Stiegler M , Susick M , Suyama J , Taylor L , Walters S , Weissman A , Williams JV , Blair M , Carter J , Chappell J , Copen E , Denney M , Graes K , Halasa N , Lindsell C , Liu Z , Longmire S , McHenry R , Short L , Tan HN , Vargas D , Wrenn J , Wyatt D , Zhu Y . medRxiv 2022 10 Background: We estimated SARS-CoV-2 Delta and Omicron-specific effectiveness of 2 and 3 mRNA COVID-19 vaccine doses in adults against symptomatic illness in US outpatient settings. Method(s): Between October 1, 2021, and February 12, 2022, research staff consented and enrolled eligible participants who had fever, cough, or loss of taste or smell and sought outpatient medical care or clinical SARS-CoV-2 testing within 10 days of illness onset. Using the test-negative design, we compared the odds of receiving 2 or 3 mRNA COVID-19 vaccine doses among SARS-CoV-2 cases versus controls using logistic regression. Regression models were adjusted for study site, age, onset week, and prior SARS-CoV-2 infection. Vaccine effectiveness (VE) was calculated as (1 - adjusted odds ratio) x 100%. Result(s): Among 3847 participants included for analysis, 574 (32%) of 1775 tested positive for SARS-CoV-2 during the Delta predominant period and 1006 (56%) of 1794 participants tested positive during the Omicron predominant period. When Delta predominated, VE against symptomatic illness in outpatient settings was 63% (95% CI: 51% to 72%) among mRNA 2-dose recipients and 96% (95% CI: 93% to 98%) for 3-dose recipients. When Omicron predominated, VE was 21% (95% CI: -6% to 41%) among 2-dose recipients and 62% (95% CI: 48% to 72%) among 3-dose recipients. Conclusion(s): In this adult population, 3 mRNA COVID-19 vaccine doses provided substantial protection against symptomatic illness in outpatient settings when the Omicron variant became the predominant cause of COVID-19 in the U.S. These findings support the recommendation for a 3rd mRNA COVID-19 vaccine dose. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
A randomized controlled trial to compare immunogenicity to cell-based versus live-attenuated influenza vaccines in children
Williams KV , Li ZN , Zhai B , Alcorn JF , Nowalk MP , Levine MZ , Kim SS , Flannery B , Moehling Geffel K , Merranko AJ , Collins M , Susick M , Clarke KS , Zimmerman RK , Martin JM . J Pediatric Infect Dis Soc 2023 12 (6) 342-352 BACKGROUND: Few studies have focused on the immune response to more recent influenza vaccine formulations such as cell-cultured inactivated influenza vaccine (ccIIV4) or live-attenuated influenza vaccine (LAIV4) in older children and young adults, or differences in immunoglobulin response using newer antibody landscape technology. METHODS: Participants ages 4-21 were randomized to receive ccIIV4 (n = 112) or LAIV4 (n = 118). A novel high-throughput multiplex influenza antibody detection assay was used to provide detailed IgG, IgA, and IgM antibody isotypes, along with hemagglutination inhibition levels (HAI), measured pre- and 28 days post-vaccination. RESULTS: The HAI and immunoglobulin isotype response to ccIIV4 was greater than LAIV4, with significant increases in IgG but not IgA or IgM. The youngest participants had the highest LAIV4 response. Prior LAIV4 vaccination was associated with a higher response to current season ccIIV4. Cross-reactive A/Delaware/55/2019(H1N1)pdm09 antibodies were present pre-vaccination and increased in response to ccIIV4, but not LAIV4. Immunoglobulin assays strongly correlated with and confirmed the findings of HAI titers to measure immune response. CONCLUSIONS: Age and prior season vaccination may play a role in the immune response in children and young adults to ccIIV4 and LAIV4. While immunoglobulin isotypes provide high-level antigen-specific information, HAI titers alone can provide a meaningful representation of day 28 post-vaccination response. CLINICAL TRIALS NO: NCT03982069. |
Analysis of metapopulation models of the transmission of SARS-CoV-2 in the United States
Vo M , Feng Z , Glasser JW , Clarke KEN , Jones JN . J Math Biol 2023 87 (2) 24 During the COVID-19 pandemic, renewal equation estimates of time-varying effective reproduction numbers were useful to policymakers in evaluating the need for and impact of mitigation measures. Our objective here is to illustrate the utility of mechanistic expressions for the basic and effective (or intrinsic and realized) reproduction numbers, [Formula: see text] and related quantities derived from a Susceptible-Exposed-Infectious-Removed (SEIR) model including features of COVID-19 that might affect transmission of SARS-CoV-2, including asymptomatic, pre-symptomatic, and symptomatic infections, with which people may be hospitalized. Expressions from homogeneous host population models can be analyzed to determine the effort needed to reduce [Formula: see text] from [Formula: see text] to 1 and contributions of modeled mitigation measures. Our model is stratified by age, 0-4, 5-9, …, 75+ years, and location, the 50 states plus District of Columbia. Expressions from such heterogeneous host population models include subpopulation reproduction numbers, contributions from the above-mentioned infectious states, metapopulation numbers, subpopulation contributions, and equilibrium prevalence. While the population-immunity at which [Formula: see text] has captured the popular imagination, the metapopulation [Formula: see text] could be attained in an infinite number of ways even if only one intervention (e.g., vaccination) were capable of reducing [Formula: see text] However, gradients of expressions derived from heterogeneous host population models,[Formula: see text] can be evaluated to identify optimal allocations of limited resources among subpopulations. We illustrate the utility of such analytical results by simulating two hypothetical vaccination strategies, one uniform and other indicated by [Formula: see text] as well as the actual program estimated from one of the CDC's nationwide seroprevalence surveys conducted from mid-summer 2020 through the end of 2021. |
Innovative approaches to improve COVID-19 case investigation and contact tracing among refugees, immigrants, and migrants: Lessons learned from a newly established National Resource Center
Mann EM , Weinberg M , Dawson-Hahn E , Clarke SK , Olmsted M , Bertelsen N , Arun R , Keaveney M , Miko S , Kircher A , Pendleton AE , Hendel-Paterson B , Prasad S , Stauffer WM . J Immigr Minor Health 2023 1-9 Effective COVID-19 case investigation and contact tracing (CICT) among refugee, immigrant, and migrant (RIM) communities requires innovative approaches to address linguistic, cultural and community specific preferences. The National Resource Center for Refugees, Immigrants, and Migrants (NRC-RIM) is a CDC-funded initiative to support state and local health departments with COVID-19 response among RIM communities, including CICT. This note from the field will describe NRC-RIM and initial outcomes and lessons learned, including the use of human-centered design to develop health messaging around COVID-19 CICT; training developed for case investigators, contact tracers, and other public health professionals working with RIM community members; and promising practices and other resources related to COVID-19 CICT among RIM communities that have been implemented by health departments, health systems, or community-based organizations. |
Reaching the First 90: Improving Inpatient Pediatric Provider-Initiated HIV Testing and Counseling Using a Quality Improvement Collaborative Strategy in Tanzania
Dougherty G , Panya M , Madevu-Matson C , Anyalechi GE , Clarke K , Fayorsey R , Kamonga M , Kimambo S , Lutkam D , Mugisha V , Mtiro H , Msuke S , Ramadhani A , Sipemba J , Urasa P , Rabkin M . J Assoc Nurses AIDS Care 2019 30 (6) 682-690 Although the United Republic of Tanzania has made remarkable progress in scaling up HIV services, substantial gaps in pediatric coverage remain (Joint United Nations Programme on HIV/AIDS, 2013). Tanzania is among the countries with the world's lowest pediatric antiretroviral therapy coverage (Joint United Nations Programme on HIV/AIDS, 2013), and the Ministry of Health (MOH), Community, Development, Gender, Elderly and Children has prioritized expanding access to HIV testing, care, and treatment for children (United Republic of Tanzania Ministry of Health and Social Welfare, 2012). | | Improving the identification of children living with HIV is a critical first step to expanding treatment coverage. In countries with generalized HIV epidemics, ill children presenting to health facilities have a higher HIV prevalence than the general pediatric population (Cohn, Whitehouse, Tuttle, Lueck, & Tran, 2016; Kankasa et al., 2009; Preidis, 2013; Wagner et al., 2015). Offering routine opt-out HIV testing to at-risk pediatric subpopulations (those presenting to health care with signs of illness or for admission, malnutrition, or tuberculosis treatment) is a high-yield identification strategy (Mutanga et al., 2012). Because these children and their caregivers are actively seeking health services and are easy to reach, they present a unique opportunity to identify those most in need of HIV care and to initiate treatment rapidly. |
From Surveillance To Control: Evaluation of A Larvicide Intervention Against Aedes aegypti In Brownsville, Texas
Garcia-Luna SM , Chaves LF , Juarez JG , Bolling BG , Rodriguez A , Presas YE , Mutebi JP , Weaver SC , Badillo-Vargas IE , Hamer GL , Qualls WA . J Am Mosq Control Assoc 2019 35 (3) 233-237 South Texas is recognized as a potential area for the emergence and re-emergence of mosquito-borne diseases due to recent circulation of Zika, chikungunya, and dengue viruses. During 2017, high Aedes aegypti abundance found in the city of Brownsville, TX, in combination with the previous year's local transmission of Zika virus, triggered the activation of the Texas Department of State Health Services Emergency Mosquito Control Contingency Contract. A contract with the Clarke Environmental and Mosquito Control was a response to control Ae. aegypti, using a ground-based wide-area larvicide spray (WALS™) containing Bacillus thuringiensis israelensis. The WALS application was evaluated through a field-based bioassay and by comparing surveillance data pre- and post-WALS application. The WALS application bioassay demonstrated that the larvicide was effective up to 60 m into the target properties. Additionally, the number of Ae. aegypti captured in traps decreased in the WALS intervention areas compared with the untreated control areas, with an estimated 29% control. |
Initial public health response and interim clinical guidance for the 2019 novel coronavirus outbreak - United States, December 31, 2019-February 4, 2020.
Patel A , Jernigan DB , 2019-nCOV CDC Response Team , Abdirizak Fatuma , Abedi Glen , Aggarwal Sharad , Albina Denise , Allen Elizabeth , Andersen Lauren , Anderson Jade , Anderson Megan , Anderson Tara , Anderson Kayla , Bardossy Ana Cecilia , Barry Vaughn , Beer Karlyn , Bell Michael , Berger Sherri , Bertulfo Joseph , Biggs Holly , Bornemann Jennifer , Bornstein Josh , Bower Willie , Bresee Joseph , Brown Clive , Budd Alicia , Buigut Jennifer , Burke Stephen , Burke Rachel , Burns Erin , Butler Jay , Cantrell Russell , Cardemil Cristina , Cates Jordan , Cetron Marty , Chatham-Stephens Kevin , Chatham-Stevens Kevin , Chea Nora , Christensen Bryan , Chu Victoria , Clarke Kevin , Cleveland Angela , Cohen Nicole , Cohen Max , Cohn Amanda , Collins Jennifer , Conners Erin , Curns Aaron , Dahl Rebecca , Daley Walter , Dasari Vishal , Davlantes Elizabeth , Dawson Patrick , Delaney Lisa , Donahue Matthew , Dowell Chad , Dyal Jonathan , Edens William , Eidex Rachel , Epstein Lauren , Evans Mary , Fagan Ryan , Farris Kevin , Feldstein Leora , Fox LeAnne , Frank Mark , Freeman Brandi , Fry Alicia , Fuller James , Galang Romeo , Gerber Sue , Gokhale Runa , Goldstein Sue , Gorman Sue , Gregg William , Greim William , Grube Steven , Hall Aron , Haynes Amber , Hill Sherrasa , Hornsby-Myers Jennifer , Hunter Jennifer , Ionta Christopher , Isenhour Cheryl , Jacobs Max , Jacobs Slifka Kara , Jernigan Daniel , Jhung Michael , Jones-Wormley Jamie , Kambhampati Anita , Kamili Shifaq , Kennedy Pamela , Kent Charlotte , Killerby Marie , Kim Lindsay , Kirking Hannah , Koonin Lisa , Koppaka Ram , Kosmos Christine , Kuhar David , Kuhnert-Tallman Wendi , Kujawski Stephanie , Kumar Archana , Landon Alexander , Lee Leslie , Leung Jessica , Lindstrom Stephen , Link-Gelles Ruth , Lively Joana , Lu Xiaoyan , Lynch Brian , Malapati Lakshmi , Mandel Samantha , Manns Brian , Marano Nina , Marlow Mariel , Marston Barbara , McClung Nancy , McClure Liz , McDonald Emily , McGovern Oliva , Messonnier Nancy , Midgley Claire , Moulia Danielle , Murray Janna , Noelte Kate , Noonan-Smith Michelle , Nordlund Kristen , Norton Emily , Oliver Sara , Pallansch Mark , Parashar Umesh , Patel Anita , Patel Manisha , Pettrone Kristen , Pierce Taran , Pietz Harald , Pillai Satish , Radonovich Lewis , Reagan-Steiner Sarah , Reel Amy , Reese Heather , Rha Brian , Ricks Philip , Rolfes Melissa , Roohi Shahrokh , Roper Lauren , Rotz Lisa , Routh Janell , Sakthivel Senthil Kumar Sarmiento Luisa , Schindelar Jessica , Schneider Eileen , Schuchat Anne , Scott Sarah , Shetty Varun , Shockey Caitlin , Shugart Jill , Stenger Mark , Stuckey Matthew , Sunshine Brittany , Sykes Tamara , Trapp Jonathan , Uyeki Timothy , Vahey Grace , Valderrama Amy , Villanueva Julie , Walker Tunicia , Wallace Megan , Wang Lijuan , Watson John , Weber Angie , Weinbaum Cindy , Weldon William , Westnedge Caroline , Whitaker Brett , Whitaker Michael , Williams Alcia , Williams Holly , Willams Ian , Wong Karen , Xie Amy , Yousef Anna . Am J Transplant 2020 20 (3) 889-895 This article summarizes what is currently known about the 2019 novel coronavirus and offers interim guidance. |
Investigation of donor-derived Strongyloides stercoralis infection in multiple solid organ transplant recipients-California, Michigan, Ohio, 2022
Adeyemo A , Montgomery S , Chancey RJ , Annambhotla P , Barba L , Clarke T , Williams J , Malilay A , Coyle J . Transpl Infect Dis 2023 25 (3) e14059 BACKGROUND: The Centers for Disease Control and Prevention led an investigation to determine if Strongyloides infection in a right kidney recipient was an existing chronic infection, or if the infection was transmitted from an infected organ donor. METHODS: Evidence regarding the organ donor and organ recipients Strongyloides testing, treatment, and risk factors were gathered and evaluated. The case classification algorithm created by the Disease Transmission Advisory Committee was utilized. RESULTS: The organ donor had risk factors for Strongyloides infection; the banked donor specimen, submitted for serology testing 112 days post-donor death, was positive. The right kidney recipient was negative for Strongyloides infection pretransplant. Strongyloides infection was diagnosed via small bowel and stomach biopsies. The left kidney recipient had risk factors for Strongyloides infection. Two posttransplant Strongyloides antibody tests were negative at 59 and 116 days posttransplant; repeat antibody tests returned positive at 158 and 190 days posttransplant. Examination of bronchial alveolar lavage fluid collected 110 days posttransplant from the heart recipient showed a parasite morphologically consistent with Strongyloides species. She subsequently developed complications from Strongyloides infection, including hyperinfection syndrome and disseminated strongyloidiasis. Based on the evidence from our investigation, donor-derived strongyloidiasis was suspected in one recipient and proven in two recipients. CONCLUSION: The results of this investigation support the importance of preventing donor-derived Strongyloides infections by laboratory-based serology testing of solid organ donors. Donor positive testing results would direct the monitoring and treatment of recipients to avoid severe complications. |
Multi-state implementation of go NAPSACC to support healthy practices in the early care and education setting
West M , Dooyema C , Smith FT , Willis EA , Clarke E , Shira Starr A , Hall K , Hales DP , Ward DS . Health Promot Pract 2023 24 145s-151s Childhood obesity in the United States is a serious problem that puts children at risk for poor health. Effective state-wide interventions are needed to address childhood obesity risk factors. Embedding evidence-based initiatives into state-level Early Care and Education (ECE) systems has the potential to improve health environments and promote healthy habits for the 12.5 million children attending ECE programs. Go NAPSACC, an online program that was adapted from an earlier paper version of Nutrition and Physical Activity Self-Assessment for Child Care (NAPSACC or NAP SACC), provides an evidence-based approach that aligns with national guidance from Caring for Our Children and the Centers for Disease Control and Prevention. This study describes approaches undertaken across 22 states from May 2017 to May 2022 to implement and integrate Go NAPSACC into state-level systems. This study describes challenges encountered, strategies employed, and lessoned learned while implementing Go NAPSACC state-wide. To date, 22 states have successfully trained 1,324 Go NAPSACC consultants, enrolled 7,152 ECE programs, and aimed to impact 344,750 children in care. By implementing evidence-based programs, such as Go NAPSACC, ECE programs state-wide can make changes and monitor progress on meeting healthy best practice standards, increasing opportunities for all children to have a healthy start. |
Use of severe acute respiratory syndrome coronavirus 2 antibody tests by US infectious disease physicians: Results of an emerging infections network survey, March 2022
Gundlapalli AV , Beekmann SE , Jones JM , Thornburg NJ , Clarke KEN , Uyeki TM , Satheshkumar PS , Carroll DS , Plumb ID , Briggs-Hagen M , Santibañez S , David-Ferdon C , Polgreen PM , McDonald LC . Open Forum Infect Dis 2023 10 (3) ofad091 BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests have had limited recommended clinical application during the coronavirus disease 2019 (COVID-19) pandemic. To inform clinical practice, an understanding is needed of current perspectives of United States-based infectious disease (ID) physicians on the use, interpretation, and need for SARS-CoV-2 antibody tests. METHODS: In March 2022, members of the Emerging Infections Network (EIN), a national network of practicing ID physicians, were surveyed on types of SARS-CoV-2 antibody assays ordered, interpretation of test results, and clinical scenarios for which antibody tests were considered. RESULTS: Of 1867 active EIN members, 747 (40%) responded. Among the 583 who managed or consulted on COVID-19 patients, a majority (434/583 [75%]) had ordered SARS-CoV-2 antibody tests and were comfortable interpreting positive (452/578 [78%]) and negative (405/562 [72%]) results. Antibody tests were used for diagnosing post-COVID-19 conditions (61%), identifying prior SARS-CoV-2 infection (60%), and differentiating prior infection and response to COVID-19 vaccination (37%). Less than a third of respondents had used antibody tests to assess need for additional vaccines or risk stratification. Lack of sufficient evidence for use and nonstandardized assays were among the most common barriers for ordering tests. Respondents indicated that statements from professional societies and government agencies would influence their decision to order SARS-CoV-2 antibody tests for clinical decision making. CONCLUSIONS: Practicing ID physicians are using SARS-CoV-2 antibody tests, and there is an unmet need for clarifying the appropriate use of these tests in clinical practice. Professional societies and US government agencies can support clinicians in the community through the creation of appropriate guidance. |
Estimated SARS-CoV-2 antibody seroprevalence trends and relationship to reported case prevalence from a repeated, cross-sectional study in the 50 states and the District of Columbia, United States-October 25, 2020-February 26, 2022.
Wiegand RE , Deng Y , Deng X , Lee A , Meyer WA3rd , Letovsky S , Charles MD , Gundlapalli AV , MacNeil A , Hall AJ , Thornburg NJ , Jones J , Iachan R , Clarke KEN . Lancet Reg Health Am 2023 18 100403 BACKGROUND: Sero-surveillance of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can reveal trends and differences in subgroups and capture undetected or unreported infections that are not included in case-based surveillance systems. METHODS: Cross-sectional, convenience samples of remnant sera from clinical laboratories from 51 U.S. jurisdictions were assayed for infection-induced SARS-CoV-2 antibodies biweekly from October 25, 2020, to July 11, 2021, and monthly from September 6, 2021, to February 26, 2022. Test results were analyzed for trends in infection-induced, nucleocapsid-protein seroprevalence using mixed effects models that adjusted for demographic variables and assay type. FINDINGS: Analyses of 1,469,792 serum specimens revealed U.S. infection-induced SARS-CoV-2 seroprevalence increased from 8.0% (95% confidence interval (CI): 7.9%-8.1%) in November 2020 to 58.2% (CI: 57.4%-58.9%) in February 2022. The U.S. ratio of the change in estimated seroprevalence to the change in reported case prevalence was 2.8 (CI: 2.8-2.9) during winter 2020-2021, 2.3 (CI: 2.0-2.5) during summer 2021, and 3.1 (CI: 3.0-3.3) during winter 2021-2022. Change in seroprevalence to change in case prevalence ratios ranged from 2.6 (CI: 2.3-2.8) to 3.5 (CI: 3.3-3.7) by region in winter 2021-2022. INTERPRETATION: Ratios of the change in seroprevalence to the change in case prevalence suggest a high proportion of infections were not detected by case-based surveillance during periods of increased transmission. The largest increases in the seroprevalence to case prevalence ratios coincided with the spread of the B.1.1.529 (Omicron) variant and with increased accessibility of home testing. Ratios varied by region and season with the highest ratios in the midwestern and southern United States during winter 2021-2022. Our results demonstrate that reported case counts did not fully capture differing underlying infection rates and demonstrate the value of sero-surveillance in understanding the full burden of infection. Levels of infection-induced antibody seroprevalence, particularly spikes during periods of increased transmission, are important to contextualize vaccine effectiveness data as the susceptibility to infection of the U.S. population changes. FUNDING: This work was supported by the Centers for Disease Control and Prevention, Atlanta, Georgia. |
Childhood exposures to environmental chemicals and neurodevelopmental outcomes in congenital heart disease
Gaynor JW , Burnham NB , Ittenbach RF , Gerdes M , Bernbaum JC , Zackai E , Licht DJ , Russell WW , Zullo EE , Miller T , Hakonarson H , Clarke KA , Jarvik GP , Calafat AM , Bradman A , Bellinger DC , Henretig FM , Coker ES . PLoS One 2022 17 (11) e0277611 BACKGROUND: Children with congenital heart defects have an increased risk of neurodevelopmental disability. The impact of environmental chemical exposures during daily life on neurodevelopmental outcomes in toddlers with congenital heart defects is unknown. METHODS: This prospective study investigated the impacts of early childhood exposure to mixtures of environmental chemicals on neurodevelopmental outcomes after cardiac surgery. Outcomes were assessed at 18 months of age using The Bayley Scales of Infant and Toddler Development-III. Urinary concentrations of exposure biomarkers of pesticides, phenols, parabens, and phthalates, and blood levels of lead, mercury, and nicotine were measured at the same time point. Bayesian profile regression and weighted quantile sum regression were utilized to assess associations between mixtures of biomarkers and neurodevelopmental scores. RESULTS: One-hundred and forty infants were enrolled, and 110 (79%) returned at 18 months of age. Six biomarker exposure clusters were identified from the Bayesian profile regression analysis; and the pattern was driven by 15 of the 30 biomarkers, most notably 13 phthalate biomarkers. Children in the highest exposure cluster had significantly lower adjusted language scores by -9.41 points (95%CI: -17.2, -1.7) and adjusted motor scores by -4.9 points (-9.5, -0.4) compared to the lowest exposure. Weighted quantile sum regression modeling for the overall exposure-response relationship showed a significantly lower adjusted motor score ( = -2.8 points [2.5th and 97.5th percentile: -6.0, -0.6]). The weighted quantile sum regression index weights for several phthalates, one paraben, and one phenol suggest their relevance for poorer neurodevelopmental outcomes. CONCLUSIONS: Like other children, infants with congenital heart defects are exposed to complex mixtures of environmental chemicals in daily life. Higher exposure biomarker concentrations were associated with significantly worse performance for language and motor skills in this population. |
Guidance for selecting model options in the National Cancer Institute Joinpoint Regression Software
Irimata KE , Bastian BA , Clarke TC , Curtin SC , Badwe R , Rui P . Vital Health Stat 1 2022 (194) 1-22 The purpose of this report is to provide guidance to users of NCHS data in the selection of modeling options when using the NCI Joinpoint regression software to analyze trends. This report complements another report, "National Center for Health Statistics Guidelines for Analysis of Trends." Considerations are presented for selecting the modeling options, with examples illustrating the choices. The tradeoffs and consequences of choosing the various modeling options using data from NCHS data systems are discussed.encounters. |
Pediatric Infection-Induced SARS-CoV-2 Seroprevalence Increases and Seroprevalence by Type of Clinical Care-September 2021-February 2022.
Clarke KEN , Kim Y , Jones J , Lee A , Deng Y , Nycz E , Iachan R , Gundlapalli AV , MacNeil A , Hall A . J Infect Dis 2022 227 (3) 364-370 BACKGROUND AND OBJECTIVES: Trends in estimates of US pediatric SARS-CoV-2 infection-induced seroprevalence from commercial laboratory specimens may overrepresent children with frequent healthcare needs. We examined seroprevalence trends and compared seroprevalence estimates by testing type and diagnostic coding. METHODS: Cross-sectional convenience samples of residual sera between September 2021 and February 2022 from 52 U.S. jurisdictions were assayed for infection-induced SARS-CoV-2 antibodies; monthly seroprevalence estimates were calculated by age group. Multivariate logistic analyses compared seroprevalence estimates for specimens associated with ICD-10 codes and laboratory orders indicating well-child care with estimates for other pediatric specimens. RESULTS: Infection-induced SARS-CoV-2 seroprevalence increased in each age group; from 30% to 68% (1-4 years), 38% to 77% (5-11 years), and 40% to 74% (12-17 years). On multivariate analysis, patients with well-child ICD-10 codes were seropositive more often than other patients aged 1-17 years (adjusted prevalence ratio [aPR] 1.04; 95% CI 1.02-1.07); children aged 9-11 years receiving standard lipid screening were seropositive more often than those receiving other laboratory tests (1.05; 1.02-1.08). CONCLUSIONS: Infection-induced seroprevalence more than doubled among children under 12 between September 2021 and February 2022, and increased 85% in adolescents. Differences in seroprevalence by care type did not substantially impact US pediatric seroprevalence estimates. |
Severity of COVID-19 Hospitalization Outcomes and Patient Disposition Differ by Disability Status and Disability Type.
Clarke KEN , Hong K , Schoonveld M , Greenspan AI , Montgomery M , Thierry JM . Clin Infect Dis 2022 76 (5) 871-880 BACKGROUND: Systemic inequities may place people with disabilities at higher risk of severe COVID-19 illness or lower likelihood to be discharged home after hospitalization. We examined whether severity of COVID-19 hospitalization outcomes and disposition differ by disability status and disability type. METHODS: In a retrospective analysis of April 2020-November 2021 hospital-based administrative data among 745,375 people hospitalized with COVID-19 from 866 US hospitals, people with disabilities (n = 120,360) were identified via ICD-10-CM codes. Outcomes compared by disability status included intensive care admission, invasive mechanical ventilation (IMV), in-hospital mortality, 30-day readmission, length of stay, and disposition (discharge to home, long-term care facility (LTCF), or skilled nursing facility (SNF). RESULTS: People with disabilities had increased risks of IMV (aRR: 1.05; 95%CI: 1.03-1.08) and in-hospital mortality (1.04; 1.02-1.06) compared to those with no disability; risks were higher among people with intellectual and developmental disabilities (IDD) (IMV [1.34; 1.28-1.40], mortality [1.31; 1.26-1.37]) or mobility disabilities (IMV [1.13; 1.09-1.16], mortality [1.04; 1.01-1.07]). Risk of readmission was increased among people with any disability (1.23; 1.20-1.27) and each disability type. Risks of discharge to a LTCF (1.45, 1.39-1.49) or SNF (1.78, 1.74-1.81) were increased among community-dwelling people with each disability type. CONCLUSIONS: Severity of COVID-19 hospitalization outcomes vary by disability status and type; IDD and mobility disabilities were associated with higher risks of severe outcomes. Disparities such as differences in discharge disposition by disability status require further study which would be facilitated by standardized data on disability. Increased readmission across disability types indicates a need to improve discharge planning and support services. |
Analysis of Serological Surveys of Antibodies to SARS-CoV-2 in the United States to Estimate Parameters Needed for Transmission Modeling and to Evaluate and Improve the Accuracy of Predictions.
Glasser JW , Feng Z , Vo M , Jones JN , Clarke KEN . J Theor Biol 2022 556 111296 Seroprevalence studies can estimate proportions of the population that have been infected or vaccinated, including infections that were not reported because of the lack of symptoms or testing. Based on information from studies in the United States from mid-summer 2020 through the end of 2021, we describe proportions of the population with antibodies to SARS-CoV-2 as functions of age and time. Slices through these surfaces at arbitrary times provide initial and target conditions for simulation modeling. They also provide the information needed to calculate age-specific forces of infection, attack rates, and - together with contact rates - age-specific probabilities of infection on contact between susceptible and infectious people. We modified the familiar Susceptible-Exposed-Infectious-Removed (SEIR) model to include features of the biology of COVID-19 that might affect transmission of SARS-CoV-2 and stratified by age and location. We consulted the primary literature or subject matter experts for contact rates and other parameter values. Using time-varying Oxford COVID-19 Government Response Tracker assessments of US state and DC efforts to mitigate the pandemic and compliance with non-pharmaceutical interventions (NPIs) from a YouGov survey fielded in the US during 2020, we estimate that the efficacy of social-distancing when possible and mask-wearing otherwise at reducing susceptibility or infectiousness was 31% during the fall of 2020. Initialized from seroprevalence among people having commercial laboratory tests for purposes other than SARS-CoV-2 infection assessments on 7 September 2020, our age- and location-stratified SEIR population model reproduces seroprevalence among members of the same population on 25 December 2020 quite well. Introducing vaccination mid-December 2020, first of healthcare and other essential workers, followed by older adults, people who were otherwise immunocompromised, and then progressively younger people, our metapopulation model reproduces seroprevalence among blood donors on 4 April 2021 less well, but we believe that the discrepancy is due to vaccinations being under-reported or blood donors being disproportionately vaccinated, if not both. As experimenting with reliable transmission models is the best way to assess the indirect effects of mitigation measures, we determined the impact of vaccination, conditional on NPIs. Results indicate that, during this period, vaccination substantially reduced infections, hospitalizations and deaths. This manuscript was submitted as part of a theme issue on "Modelling COVID-19 and Preparedness for Future Pandemics." |
Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-nave infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
Adigweme I , Akpalu E , Yisa M , Donkor S , Jarju LB , Danso B , Mendy A , Jeffries D , Njie A , Bruce A , Royals M , Goodson JL , Prausnitz MR , McAllister D , Rota PA , Henry S , Clarke E . Trials 2022 23 (1) 775 BACKGROUND: New strategies to increase measles and rubella vaccine coverage, particularly in low- and middle-income countries, are needed if elimination goals are to be achieved. With this regard, measles and rubella vaccine microneedle patches (MRV-MNP), in which the vaccine is embedded in dissolving microneedles, offer several potential advantages over subcutaneous delivery. These include ease of administration, increased thermostability, an absence of sharps waste, reduced overall costs and pain-free administration. This trial will provide the first clinical trial data on MRV-MNP use and the first clinical vaccine trial of MNP technology in children and infants. METHODS: This is a phase 1/2, randomized, active-controlled, double-blind, double-dummy, age de-escalation trial. Based on the defined eligibility criteria for the trial, including screening laboratory investigations, 45 adults [18-40 years] followed by 120 toddlers [15-18 months] and 120 infants [9-10 months] will be enrolled in series. To allow double-blinding, participants will receive either the MRV-MNP and a placebo (0.9% sodium chloride) subcutaneous (SC) injection or a placebo MNP and the MRV by SC injection (MRV-SC). Local and systemic adverse event data will be collected for 14 days following study product administration. Safety laboratories will be repeated on day 7 and, in the adult cohort alone, on day 14. Unsolicited adverse events including serious adverse events will be collected until the final study visit for each participant on day 180. Measles and rubella serum neutralizing antibodies will be measured at baseline, on day 42 and on day 180. Cohort progression will be dependent on review of the unblinded safety data by an independent data monitoring committee. DISCUSSION: This trial will provide the first clinical data on the use of a MNP to deliver the MRV and the first data on the use of MNPs in a paediatric population. It will guide future product development decisions for what may be a key technology for future measles and rubella elimination. TRIAL REGISTRATION: Pan-African Clinical Trials Registry 202008836432905 . CLINICALTRIALS: gov NCT04394689. |
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