Last data update: Apr 22, 2024. (Total: 46599 publications since 2009)
Records 1-9 (of 9 Records) |
Query Trace: Mayo Lamberte J[original query] |
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Serum per- and polyfluoroalkyl substance concentrations and longitudinal change in post-infection and post-vaccination SARS-CoV-2 antibodies
Hollister J , Caban-Martinez AJ , Ellingson KD , Beitel S , Fowlkes AL , Lutrick K , Tyner H , Naleway AL , Yoon SK , Gaglani M , Hunt D , Meece J , Mayo Lamberte J , Schaefer Solle N , Rose S , Dunnigan K , Khan SM , Kuntz JL , Fisher JM , Coleman A , Britton A , Thiese M , Hegmann K , Pavuk M , Ramadan F , Fuller S , Nematollahi A , Sprissler R , Burgess JL . Environ Res 2023 239 117297 Per- and polyfluoroalkyl substances (PFAS) are ubiquitous throughout the United States. Previous studies have shown PFAS exposure to be associated with a reduced immune response. However, the relationship between serum PFAS and antibody levels following SARS-CoV-2 infection or COVID-19 vaccination has not been examined. We examined differences in peak immune response and the longitudinal decline of antibodies following SARS-CoV-2 infection and COVID-19 vaccination by serum PFAS levels in a cohort of essential workers in the United States. We measured serum antibodies using an in-house semi-quantitative enzyme-linked immunosorbent assay (ELISA). Two cohorts contributed blood samples following SARS-CoV-2 infection or COVID-19 vaccination. We used linear mixed regression models, adjusting for age, race/ethnicity, gender, presence of chronic conditions, location, and occupation, to estimate differences in immune response with respect to serum PFAS levels. Our study populations included 153 unvaccinated participants that contributed 316 blood draws over a 14-month period following infection, and 860 participants and 2451 blood draws over a 12-month period following vaccination. Higher perfluorooctane sulfonic acid (PFOS), perfluorohexane sulfonic acid (PFHxS), and perfluorononanoic acid (PFNA) concentrations were associated with a lower peak antibody response after infection (p = 0.009, 0.031, 0.015). Higher PFOS, perfluorooctanoic acid (PFOA), PFHxS, and PFNA concentrations were associated with slower declines in antibodies over time after infection (p = 0.003, 0.014, 0.026, 0.025). PFOA, PFOS, PFHxS, and PFNA serum concentrations prior to vaccination were not associated with differences in peak antibody response after vaccination or with differences in decline of antibodies over time after vaccination. These results suggest that elevated PFAS may impede potential immune response to SARS-CoV-2 infection by blunting peak antibody levels following infection; the same finding was not observed for immune response to vaccination. |
Prevention and Attenuation of COVID-19 by BNT162b2 and mRNA-1273 Vaccines (preprint)
Thompson MG , Burgess JL , Naleway AL , Tyner H , Yoon SK , Meece J , Olsho LEW , Caban-Martinez AJ , Fowlkes AL , Lutrick K , Groom HC , Dunnigan K , Odean MJ , Hegmann K , Stefanski E , Edwards LJ , Schaefer-Solle N , Grant L , Ellingson K , Kuntz JL , Zunie T , Thiese MS , Ivacic L , Wesley MG , Mayo Lamberte J , Sun X , Smith ME , Phillips AL , Groover KD , Yoo YM , Gerald J , Brown RT , Herring MK , Joseph G , Beitel S , Morrill TC , Mak J , Rivers P , Poe BP , Lynch B , Zhou Y , Zhang J , Kelleher A , Li Y , Dickerson M , Hanson E , Guenther K , Tong S , Bateman A , Reisdorf E , Barnes J , Azziz-Baumgartner E , Hunt DR , Arvay ML , Kutty P , Fry AM , Gaglani M . medRxiv 2021 2021.06.01.21257987 BACKGROUND Information is limited on messenger RNA (mRNA) BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccine effectiveness (VE) in preventing SARS-CoV-2 infection or attenuating disease when administered in real-world conditions.METHODS Prospective cohorts of 3,975 healthcare personnel, first responders, and other essential and frontline workers completed weekly SARS-CoV-2 testing during December 14 2020—April 10 2021. Self-collected mid-turbinate nasal swabs were tested by qualitative and quantitative reverse-transcription–polymerase-chain-reaction (RT-PCR). VE was calculated as 100%×(1−hazard ratio); adjusted VE was calculated using vaccination propensity weights and adjustments for site, occupation, and local virus circulation.RESULTS SARS-CoV-2 was detected in 204 (5.1%) participants; 16 were partially (≥14 days post-dose-1 to 13 days after dose-2) or fully (≥14 days post-dose-2) vaccinated, and 156 were unvaccinated; 32 with indeterminate status (<14 days after dose-1) were excluded. Adjusted mRNA VE of full vaccination was 91% (95% confidence interval [CI]=76%–97%) against symptomatic or asymptomatic SARS-CoV-2 infection; VE of partial vaccination was 81% (95% CI=64%-90%). Among partially or fully vaccinated participants with SARS-CoV-2 infection, mean viral RNA load (Log10 copies/mL) was 40% lower (95% CI=16%-57%), the risk of self-reported febrile COVID-19 was 58% lower (Risk Ratio=0.42, 95% CI=0.18-0.98), and 2.3 fewer days (95% CI=0.8-3.7) were spent sick in bed compared to unvaccinated infected participants.CONCLUSIONS Authorized mRNA vaccines were highly effective among working-age adults in preventing SARS-CoV-2 infections when administered in real-world conditions and attenuated viral RNA load, febrile symptoms, and illness duration among those with breakthrough infection despite vaccination.Competing Interest StatementAllison L. Naleway reported funding from Pfizer for a meningococcal B vaccine study unrelated to the submitted work. Kurt T. Hegmann serves at the Editor of the American College of Occupational and Environmental Medicine evidence-based practice guidelines. Matthew S. These reported grants and personal fees from Reed Group and the American College of Occupational and Environmental Medicine, outside the submitted work. Other authors have reported no conflicts of interest.Funding StatementFunding provided in whole or in part by federal funds from the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention under contract numbers 75D30120R68013 awarded to Marshfield Clinic Research Laboratory, 75D30120C08379 to University of Arizona, and 75D30120C08150 awarded to Abt Associates, Inc.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 study was reviewed and approved by the University of Arizona IRB as the single IRB for this studyAll 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.YesSummary data will be available once all study objectives are met. |
COVID-19 Vaccine Perceptions and Uptake in a National Prospective Cohort of Essential Workers (preprint)
Lutrick K , Groom H , Fowlkes AL , Groover KD , Gaglani M , Rivers P , Naleway AL , Nguyen K , Herring M , Dunnigan K , Phillips A , Parker J , Mayo Lamberte J , Prather K , Thiese MS , Baccam Z , Tyner H , Yoon S . medRxiv 2021 2021.10.20.21265288 Introduction In a multi-center prospective cohort of essential workers, we assessed knowledge, attitudes, and practices (KAP) by vaccine intention, prior SARS-CoV-2 positivity, and occupation, and their impact on vaccine uptake over time.Methods Initiated in July 2020, HEROES-RECOVER cohort provided socio-demographics and COVID-19 vaccination data. Using follow-up two surveys approximately three months apart, COVID-19 vaccine KAP, intention, and receipt was collected; the first survey categorized participants as reluctant, reachable, or endorsers.Results A total of 4,803 participants were included in the analysis. Most (70%) were vaccine endorsers, 16% were reachable, and 14% were reluctant. By May 2021, 77% had received at least one vaccine dose. KAP responses strongly predicted vaccine uptake, particularly positive attitudes about safety (aOR=5.46, 95% CI: 1.4-20.8) and effectiveness (aOR=5.0, 95% CI: 1.3-19.1). Participants prior SARS-CoV-2 infection were 22% less likely to believe the COVID-19 vaccine was effective compared with uninfected participants (aOR 0.78, 95% CI: 0.64-0.96). This was even more pronounced in first responders compared with other occupations, with first responders 42% less likely to believe in COVID-19 vaccine effectiveness (aOR=0.58, 95% CI 0.40-0.84). KAP responses shifted positively, with reluctant and reachable participant scores modestly increasing in positive responses for perceived vaccine effectiveness (7% and 12%, respectively) on the second follow-up survey; 25% of initially reluctant participants received the COVID-19 vaccine.Discussion Our study demonstrates attitudes associated with COVID-19 vaccine uptake and a positive shift in attitudes over time. First responders, despite potential high exposure to SARS-CoV-2, and participants with a history of SARS-CoV-2 infection were more vaccine reluctant.Conclusions COVID-19 vaccine KAP responses predicted vaccine uptake and associated attitudes improved over time. Perceptions of the COVID-19 vaccine can shift over time. Targeting messages about the vaccine’s safety and effectiveness in reducing SARS-CoV-2 virus infection and illness severity may increase vaccine uptake for reluctant and reachable participants.Competing Interest StatementThe findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Allison L. Naleway reported funding from Pfizer for a meningococcal B vaccine study unrelated to the submitted work.Funding StatementThis study was funded by the National Center for Immunization and Respiratory Diseases and the Centers for Disease Control and Prevention (contracts 75D30120R68013 to Marshfield Clinic Research Institute, 75D30120C08379 to the University of Arizona, and 75D30120C08150 to Abt Associates).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:- Ethics committee/IRB of University of Arizona gave ethical approval for this work - Ethic committee/IRB of all RECOVER Abt sites (University of Utah, Baylor Scott & White, University of Miami, St Luke's, and Kaiser Permanente) gave ethical approval for this work - Ethics committee/IRB of Centers for Disease Control and Prevention deferred to RECOVER Abt sites and University of Arizona for this workI confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.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 repo ted 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.YesAll data produced in the present study are available upon reasonable request to the authorsFDAU.S. Food and Drug AdministrationCDCCenters for Disease Control and PreventionEUAEmergency Use AuthorizationKAPKnowledge, attitudes, and practicesHEROESArizona Healthcare, Emergency Response and Other Essential Workers SurveillanceRECOVERStudy and Research on the Epidemiology of SARS-CoV-2 in Essential Response PersonnelH-RHEROES-RECOVERHCPHealth care personnelFWFrontline workersPPEPersonal protective equipment |
SARS-CoV-2 infection history and antibody response to three COVID-19 mRNA vaccine doses.
Herring MK , Romine JK , Wesley MG , Ellingson KD , Yoon SK , Caban-Martinez AJ , Meece J , Gaglani M , Grant L , Olsho LEW , Tyner HL , Naleway AL , Khan SM , Phillips AL , Schaefer Solle N , Rose S , Mak J , Fuller SB , Hunt A , Kuntz JL , Beitel S , Yoo YM , Zheng PQ , Arani G , Mayo Lamberte J , Edwards T , Thompson MG , Sprissler R , Thornburg NJ , Lowe AA , Pilishvili T , Uhrlaub JL , Lutrick K , Burgess JL , Fowlkes AL . Clin Infect Dis 2022 76 (10) 1822-1831 BACKGROUND: Three doses of coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccines produce robust antibody responses, but data are limited among individuals previously infected with SARS-CoV-2. From a cohort of health care personnel (75.5%), first responders (4.6%), and other frontline workers (19.8%) in 6 US states, we longitudinally assessed antibody waning after dose-2, and response to dose-3, according to SARS-CoV-2 infection history. METHODS: Participants submitted sera every three months, after SARS-CoV-2 infection, and after each COVID-19 vaccine dose. Sera were tested for antibodies and reported quantitatively as area under the serial dilution curve (AUC). Changes in the AUC values over time were compared as fold-changes using a linear mixed model. RESULTS: Analysis included 388 participants who received dose-3 by November 2021. Three comparison groups: (1) vaccine only with no known prior SARS-CoV-2 infection (n = 224); (2) infection prior to dose-1 (n = 123); and (3) infection after dose 2 and before dose-3 (n = 41). The interval from dose 2 and dose 3 was approximately 8-months. After dose-3, antibody levels rose 2.5-fold (95%CI = 2.2-3.0) in group 2, and 2.9-fold (95%CI = 2.6-3.3) in group 1. Those infected within 90 days before dose-3 (and median 233 days (IQR = 213-246) after dose-2) did not increase significantly after dose-3. CONCLUSIONS: A third dose of mRNA vaccine typically elicited a robust humoral immune response among those with primary vaccination regardless of SARS-CoV-2 infection >3 months prior to boosting. Those with infection < 3 months prior to boosting did not have a significant increase in antibody concentrations in response to a booster. |
Interim Estimate of Vaccine Effectiveness of BNT162b2 (Pfizer-BioNTech) Vaccine in Preventing SARS-CoV-2 Infection Among Adolescents Aged 12-17 Years - Arizona, July-December 2021.
Lutrick K , Rivers P , Yoo YM , Grant L , Hollister J , Jovel K , Khan S , Lowe A , Baccam Z , Hanson H , Olsho LEW , Fowlkes A , Caban-Martinez AJ , Porter C , Yoon S , Meece J , Gaglani M , Burns J , Mayo Lamberte J , Nakayima Miiro F , Bissonnette A , LeClair L , Kutty PK , Romine JK , Stefanski E , Edwards LJ , Ellingson K , Gerald JK , Bedrick EJ , Madhivanan P , Krupp K , Gerald LB , Thompson M , Burgess JL . MMWR Morb Mortal Wkly Rep 2021 70 (5152) 1761-1765 The BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine has demonstrated high efficacy in preventing infection with SARS-CoV-2 (the virus that causes COVID-19) in randomized placebo-controlled Phase III trials in persons aged 12-17 years (referred to as adolescents in this report) (1); however, data on real-word vaccine effectiveness (VE) among adolescents are limited (1-3). As of December 2021, the Pfizer-BioNTech vaccine is approved by the Food and Drug Administration (FDA) for adolescents aged 16-17 years and under FDA emergency use authorization for those aged 12-15 years. In a prospective cohort in Arizona, 243 adolescents aged 12-17 years were tested for SARS-CoV-2 by reverse transcription-polymerase chain reaction (RT-PCR) each week, irrespective of symptoms, and upon onset of COVID-19-like illness during July 25-December 4, 2021; the SARS-CoV-2 B.1.617.2 (Delta) variant was the predominant strain during this study period. During the study, 190 adolescents contributed fully vaccinated person-time (≥14 days after receiving 2 doses of Pfizer-BioNTech vaccine), 30 contributed partially vaccinated person-time (receipt of 1 dose or receipt of 2 doses but with the second dose completed <14 days earlier), and 66 contributed unvaccinated person-time. Using the Cox proportional-hazards model, the estimated VE of full Pfizer-BioNTech vaccination for preventing SARS-CoV-2 infection was 92% (95% CI = 79%-97%), adjusted for sociodemographic characteristics, health information, frequency of social contact, mask use, location, and local virus circulation. These findings from a real-world setting indicate that 2 doses of Pfizer-BioNTech vaccine are highly effective in preventing SARS-CoV-2 infection among Arizona adolescents. CDC recommends COVID-19 vaccination for all eligible persons in the United States, including persons aged 12-17 years. |
COVID-19 vaccine perceptions and uptake in a national prospective cohort of essential workers.
Lutrick K , Groom H , Fowlkes AL , Groover KD , Gaglani M , Rivers P , Naleway AL , Nguyen K , Herring M , Dunnigan K , Phillips A , Parker J , Mayo Lamberte J , Prather K , Thiese MS , Baccam Z , Tyner H , Yoon S . Vaccine 2021 40 (3) 494-502 INTRODUCTION: In a multi-center prospective cohort of essential workers, we assessed knowledge, attitudes, and practices (KAP) by vaccine intention, prior SARS-CoV-2 positivity, and occupation, and their impact on vaccine uptake over time. METHODS: Initiated in July 2020, the HEROES-RECOVER cohort provided socio-demographics and COVID-19 vaccination data. Using two follow-up surveys approximately three months apart, COVID-19 vaccine KAP, intention, and receipt was collected; the first survey categorized participants as reluctant, reachable, or endorser. RESULTS: A total of 4,803 participants were included in the analysis. Most (70%) were vaccine endorsers, 16% were reachable, and 14% were reluctant. By May 2021, 77% had received at least one vaccine dose. KAP responses strongly predicted vaccine uptake, particularly positive attitudes about safety (aOR = 5.46, 95% CI: 1.4-20.8) and effectiveness (aOR = 5.0, 95% CI: 1.3-19.1). Participants' with prior SARS-CoV-2 infection were 22% less likely to believe the COVID-19 vaccine was effective compared with uninfected participants (aOR 0.78, 95% CI: 0.64-0.96). This was even more pronounced in first responders compared with other occupations, with first responders 42% less likely to believe in COVID-19 vaccine effectiveness (aOR = 0.58, 95% CI 0.40-0.84). Between administrations of the two surveys, 25% of reluctant, 56% reachable, and 83% of endorser groups received the COVID-19 vaccine. The reachable group had large increases in positive responses for questions about vaccine safety (10% of vaccinated, 34% of unvaccinated), and vaccine effectiveness (12% of vaccinated, 27% of unvaccinated). DISCUSSION: Our study demonstrates attitudes associated with COVID-19 vaccine uptake and a positive shift in attitudes over time. First responders, despite potential high exposure to SARS-CoV-2, and participants with a history of SARS-CoV-2 infection were more vaccine reluctant. CONCLUSIONS: Perceptions of the COVID-19 vaccine can shift over time. Targeting messages about the vaccine's safety and effectiveness in reducing SARS-CoV-2 virus infection and illness severity may increase vaccine uptake for reluctant and reachable participants. |
Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER): Protocol for a Multisite Longitudinal Cohort Study.
Edwards LJ , Fowlkes AL , Wesley MG , Kuntz JL , Odean MJ , Caban-Martinez AJ , Dunnigan K , Phillips AL , Grant L , Herring MK , Groom HC , Respet K , Beitel S , Zunie T , Hegmann KT , Kumar A , Joseph G , Poe B , Louzado-Feliciano P , Smith ME , Thiese MS , Schaefer-Solle N , Yoo YM , Silvera CA , Mayo Lamberte J , Mak J , McDonald LC , Stuckey MJ , Kutty P , Arvay ML , Yoon SK , Tyner HL , Burgess JL , Hunt DR , Meece J , Gaglani M , Naleway AL , Thompson MG . JMIR Res Protoc 2021 10 (12) e31574 BACKGROUND: Workers critical to emergency response and continuity of essential services during the coronavirus disease 2019 (COVID-19) pandemic are at a disproportionally high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Prospective cohort studies are needed to enhance understanding the incidence of symptomatic and asymptomatic SARS-CoV-2 infection, identifying risk factors, assessing clinical outcomes, and determining the effectiveness of vaccination. OBJECTIVE: The Research on the Epidemiology of SARS-CoV-2 in Essential Response personnel (RECOVER) prospective cohort study was designed to estimate the incidence of symptomatic and asymptomatic SARS-CoV-2 infection, examine risk factors for infection and clinical spectrum of illness, and assess effectiveness of vaccination among essential workers. METHODS: The RECOVER multi-site network was initiated in August 2020 and aims to enroll 3,000 healthcare personnel (HCP), first responders, and other essential and frontline workers (EFW) in six U.S. locations. Data on participant demographics, medical history, and vaccination history are collected at baseline and throughout the study. Active surveillance for symptoms of COVID-19-like illness (CLI), accessing medical care, and symptom duration are ascertained by text messages, e-mails, and direct participant or medical record reports. Participants self-collect a mid-turbinate nasal swab weekly, regardless of symptoms, and two additional respiratory specimens at the onset of CLI. Blood is collected upon enrollment, every three months, approximately 28 days after a reverse-transcription-polymerase-chain-reaction (RT-PCR)-confirmed SARS-CoV-2 infection, and 14-28 days after a dose of any COVID-19 vaccine. Beginning in February 2021, household members of RT-PCR-confirmed participants self-collect mid-turbinate nasal swabs daily for ten days. RESULTS: The study observation period began in August 2020 and is currently expected to continue through spring 2022. There are 2,623 actively enrolled RECOVER participants, including 252 participants who were found to be positive for SARS-CoV-2 by RT-PCR. Enrollment is ongoing at three of six study site locations. CONCLUSIONS: Data collected through the cohort are expected to provide important public health information for essential workers at high risk for occupational exposure to SARS-CoV-2 and allow early evaluation of COVID-19 vaccine effectiveness. INTERNATIONAL REGISTERED REPORT: DERR1-10.2196/31574. |
Prevention and Attenuation of Covid-19 with the BNT162b2 and mRNA-1273 Vaccines.
Thompson MG , Burgess JL , Naleway AL , Tyner H , Yoon SK , Meece J , Olsho LEW , Caban-Martinez AJ , Fowlkes AL , Lutrick K , Groom HC , Dunnigan K , Odean MJ , Hegmann K , Stefanski E , Edwards LJ , Schaefer-Solle N , Grant L , Ellingson K , Kuntz JL , Zunie T , Thiese MS , Ivacic L , Wesley MG , Mayo Lamberte J , Sun X , Smith ME , Phillips AL , Groover KD , Yoo YM , Gerald J , Brown RT , Herring MK , Joseph G , Beitel S , Morrill TC , Mak J , Rivers P , Poe BP , Lynch B , Zhou Y , Zhang J , Kelleher A , Li Y , Dickerson M , Hanson E , Guenther K , Tong S , Bateman A , Reisdorf E , Barnes J , Azziz-Baumgartner E , Hunt DR , Arvay ML , Kutty P , Fry AM , Gaglani M . N Engl J Med 2021 385 (4) 320-329 BACKGROUND: Information is limited regarding the effectiveness of the two-dose messenger RNA (mRNA) vaccines BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) in preventing infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and in attenuating coronavirus disease 2019 (Covid-19) when administered in real-world conditions. METHODS: We conducted a prospective cohort study involving 3975 health care personnel, first responders, and other essential and frontline workers. From December 14, 2020, to April 10, 2021, the participants completed weekly SARS-CoV-2 testing by providing mid-turbinate nasal swabs for qualitative and quantitative reverse-transcriptase-polymerase-chain-reaction (RT-PCR) analysis. The formula for calculating vaccine effectiveness was 100% × (1 - hazard ratio for SARS-CoV-2 infection in vaccinated vs. unvaccinated participants), with adjustments for the propensity to be vaccinated, study site, occupation, and local viral circulation. RESULTS: SARS-CoV-2 was detected in 204 participants (5%), of whom 5 were fully vaccinated (≥14 days after dose 2), 11 partially vaccinated (≥14 days after dose 1 and <14 days after dose 2), and 156 unvaccinated; the 32 participants with indeterminate vaccination status (<14 days after dose 1) were excluded. Adjusted vaccine effectiveness was 91% (95% confidence interval [CI], 76 to 97) with full vaccination and 81% (95% CI, 64 to 90) with partial vaccination. Among participants with SARS-CoV-2 infection, the mean viral RNA load was 40% lower (95% CI, 16 to 57) in partially or fully vaccinated participants than in unvaccinated participants. In addition, the risk of febrile symptoms was 58% lower (relative risk, 0.42; 95% CI, 0.18 to 0.98) and the duration of illness was shorter, with 2.3 fewer days spent sick in bed (95% CI, 0.8 to 3.7). CONCLUSIONS: Authorized mRNA vaccines were highly effective among working-age adults in preventing SARS-CoV-2 infection when administered in real-world conditions, and the vaccines attenuated the viral RNA load, risk of febrile symptoms, and duration of illness among those who had breakthrough infection despite vaccination. (Funded by the National Center for Immunization and Respiratory Diseases and the Centers for Disease Control and Prevention.). |
COVID-19 Infection, Reinfection, and Vaccine Effectiveness in a Prospective Cohort of Arizona Frontline/Essential Workers: The AZ HEROES Research Protocol.
Lutrick K , Ellingson KD , Baccam Z , Rivers P , Beitel S , Parker J , Hollister J , Sun X , Gerald JK , Komatsu K , Kim E , LaFleur B , Grant L , Yoo YM , Kumar A , Mayo Lamberte J , Cowling BJ , Cobey S , Thornburg NJ , Meece JK , Kutty P , Nikolich-Zugich J , Thompson MG , Burgess JL . JMIR Res Protoc 2021 10 (6) BACKGROUND: The Arizona Healthcare, Emergency Response, and Other Essential workers Study (AZ HEROES) aims to examine the epidemiology of SARS-CoV-2 infection and COVID-19 illness among adults with high occupational exposure risk. OBJECTIVE: Study objectives include estimating incidence of SARS-CoV-2 infection in essential workers by symptom presentation and demographic factors, determining independent effects of occupational and community exposures on incidence of SARS-CoV-2 infection, establishing molecular and immunologic characteristics of SARS-CoV-2 infection in essential workers, describing the duration and patterns of rRT-PCR-positivity, and examining post-vaccine immunologic response. METHODS: Eligible participants include Arizona residents aged 18-85 years who work at least 20 hours per week in an occupation involving regular direct contact (within three feet) with others. Recruitment goals are stratified by demographic characteristics (50% aged 40 or older, 50% women, and 50% Hispanic or American Indian), by occupation (40% healthcare personnel, 30% first responders, and 30% other essential workers), and by prior SARS-CoV-2 infection (with up to 50% seropositive at baseline). Information on sociodemographics, health and medical history, vaccination status, exposures to individuals with suspected or confirmed SARS-CoV-2 infection, use of personal protective equipment, and perceived risks are collected at enrollment and updated through quarterly surveys. Every week, participants complete active surveillance for COVID-19-like illness (CLI) and self-collect nasal swabs. Additional self-collected nasal swab and saliva specimens are collected in the event of CLI onset. Respiratory specimens are sent to Marshfield Laboratories and tested for SARS-CoV-2 by real-time reverse transcription polymerase chain reaction (rRT-PCR) assay. CLI symptoms and impact on work and productivity are followed through illness resolution. Serum specimens are collected every 3 months and additional sera are collected following incident rRT-PCR positivity and after each COVID-19 vaccine dose. Incidence of SARS-CoV-2 infections will be calculated by person-weeks at risk and compared by occupation and demographic characteristics and by seropositivity status and infection and vaccination history. RESULTS: The AZ HEROES study was funded by the Centers for Disease Control and Prevention. Enrollment began July 27, 2020 and as of May 1, 2021 a total of 3,165 participants have been enrolled in the study. CONCLUSIONS: AZ HEROES is unique in aiming to recruit a diverse sample of essential workers and prospectively following strata of SARS-CoV-2 seronegative and seropositive adults. Survey results combined with active surveillance data on exposure, CLI, weekly molecular diagnostic testing, and periodic serology will be used to estimate the incidence of symptomatic and asymptomatic SARS-CoV-2 infection, assess the intensity and durability of immune responses to natural infection and COVID-19 vaccination, and contribute to the evaluation of COVID-19 vaccine effectiveness. INTERNATIONAL REGISTERED REPORT: DERR1-10.2196/28925. |
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