Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-30 (of 35 Records) |
Query Trace: Mena L[original query] |
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At-home diagnostics solutions for chlamydia and gonorrhea
Kersh EN , Mena LA . Jama 2024 This Viewpoint discusses the US Food and Drug Administration’s authorization of marketing an at-home testing system for chlamydia and gonorrhea as a good first step in boosting access to screening and treatment and in reducing infection rates. | eng |
Novel influenza A viruses in pigs with zoonotic potential, Chile
Tapia R , Brito B , Saavedra M , Mena J , García-Salum T , Rathnasinghe R , Barriga G , Tapia K , García V , Bucarey S , Jang Y , Wentworth D , Torremorell M , Neira V , Medina RA . Microbiol Spectr 2024 e0218123 Novel H1N2 and H3N2 swine influenza A viruses (IAVs) have recently been identified in Chile. The objective of this study was to evaluate their zoonotic potential. We perform phylogenetic analyses to determine the genetic origin and evolution of these viruses, and a serological analysis to determine the level of cross-protective antibodies in the human population. Eight genotypes were identified, all with pandemic H1N1 2009-like internal genes. H1N1 and H1N2 were the subtypes more commonly detected. Swine H1N2 and H3N2 IAVs had hemagglutinin and neuraminidase lineages genetically divergent from IAVs reported worldwide, including human vaccine strains. These genes originated from human seasonal viruses were introduced into the swine population since the mid-1980s. Serological data indicate that the general population is susceptible to the H3N2 virus and that elderly and young children also lack protective antibodies against the H1N2 strains, suggesting that these viruses could be potential zoonotic threats. Continuous IAV surveillance and monitoring of the swine and human populations is strongly recommended.IMPORTANCEIn the global context, where swine serve as crucial intermediate hosts for influenza A viruses (IAVs), this study addresses the pressing concern of the zoonotic potential of novel reassortant strains. Conducted on a large scale in Chile, it presents a comprehensive account of swine influenza A virus diversity, covering 93.8% of the country's industrialized swine farms. The findings reveal eight distinct swine IAV genotypes, all carrying a complete internal gene cassette of pandemic H1N1 2009 origin, emphasizing potential increased replication and transmission fitness. Genetic divergence of H1N2 and H3N2 IAVs from globally reported strains raises alarms, with evidence suggesting introductions from human seasonal viruses since the mid-1980s. A detailed serological analysis underscores the zoonotic threat, indicating susceptibility in the general population to swine H3N2 and a lack of protective antibodies in vulnerable demographics. These data highlight the importance of continuous surveillance, providing crucial insights for global health organizations. |
Vital signs: Missed opportunities for preventing congenital syphilis - United States, 2022
McDonald R , O'Callaghan K , Torrone E , Barbee L , Grey J , Jackson D , Woodworth K , Olsen E , Ludovic J , Mayes N , Chen S , Wingard R , Johnson Jones M , Drame F , Bachmann L , Romaguera R , Mena L . MMWR Morb Mortal Wkly Rep 2023 72 (46) 1269-1274 INTRODUCTION: Congenital syphilis cases in the United States increased 755% during 2012-2021. Syphilis during pregnancy can lead to stillbirth, miscarriage, infant death, and maternal and infant morbidity; these outcomes can be prevented through appropriate screening and treatment. METHODS: A cascading framework was used to identify and classify missed opportunities to prevent congenital syphilis among cases reported to CDC in 2022 through the National Notifiable Diseases Surveillance System. Data on testing and treatment during pregnancy and clinical manifestations present in the newborn were used to identify missed opportunities to prevent congenital syphilis. RESULTS: In 2022, a total of 3,761 cases of congenital syphilis in the United States were reported to CDC, including 231 (6%) stillbirths and 51 (1%) infant deaths. Lack of timely testing and adequate treatment during pregnancy contributed to 88% of cases of congenital syphilis. Testing and treatment gaps were present in the majority of cases across all races, ethnicities, and U.S. Census Bureau regions. CONCLUSIONS AND IMPLICATIONS FOR PUBLIC HEALTH PRACTICE: Addressing missed opportunities for prevention, primarily timely testing and appropriate treatment of syphilis during pregnancy, is important for reversing congenital syphilis trends in the United States. Implementing tailored strategies addressing missed opportunities at the local and national levels could substantially reduce congenital syphilis. |
Affirming and inclusive care training for medical students and residents to reduce health disparities experienced by sexual and gender minorities: A systematic review
Cooper RL , Ramesh A , Radix AE , Reuben JS , Juarez PD , Holder CL , Belton AS , Brown KY , Mena LA , Matthews-Juarez P . Transgend Health 2023 8 (4) 307-327 PURPOSE: Providing inclusive and comprehensive gender-affirming care is critical to reducing health disparities (gaps in care) experienced by sexual and gender minorities (SGM). Currently, little is known about how medical students and residents are being trained to address the health needs of SGM persons or of the most effective methods. METHODS: We conducted a systematic review of the research literature from 2000 to 2020 on the effectiveness of teaching medical students and residents on knowledge, attitudes, and skills in addressing the health of SGM persons and the strength of the research sample, design, and methods used. RESULTS: We identified a total of 36 articles that assessed the impact of medical student and resident education on knowledge, comfort, attitudes, confidence, and skills in working with SGM patients. All studies utilized quasi-experimental designs, and found efficacious results. No study examined the impact of training on patient outcomes. CONCLUSION: Future studies will need to be powered and designed to assess the impact of training on patient outcomes. |
Biologically synthesized zinc and copper oxide nanoparticles using Cannabis sativa L. enhance soybean (Glycine max) defense against fusarium virguliforme
Karmous I , Vaidya S , Dimkpa C , Zuverza-Mena N , da Silva W , Barroso KA , Milagres J , Bharadwaj A , Abdelraheem W , White JC , Elmer WH . Pestic Biochem Physiol 2023 194 105486 In this study, zinc and copper oxide nanoparticles (NPs) were synthesized using hemp (Cannabis sativa L.) leaves (ZnONP-HL and CuONP-HL), and their antifungal potential was assessed against Fusarium virguliforme in soybean (Glycine max L.). Hemp was selected because it is known to contain large quantities of secondary metabolites that can potentially enhance the reactivity of NPs through surface property modification. Synthesizing NPs with biologically derived materials allows to avoid the use of harsh and expensive synthetic reducing and capping agents. The ZnONP-HL and CuONP-HL showed average grain/crystallite size of 13.51 nm and 7.36 nm, respectively. The biologically synthesized NPs compared well with their chemically synthesized counterparts (ZnONP chem, and CuONP chem; 18.75 nm and 10.05 nm, respectively), confirming the stabilizing role of hemp-derived biomolecules. Analysis of the hemp leaf extract and functional groups that were associated with ZnONP-HL and CuONP-HL confirmed the presence of terpenes, flavonoids, and phenolic compounds. Biosynthesized NPs were applied on soybeans as bio-nano-fungicides against F. virguliforme via foliar treatments. ZnONP-HL and CuONP-HL at 200 μg/mL significantly (p < 0.05) increased (∼ 50%) soybean growth, compared to diseased controls. The NPs improved the nutrient (e.g., K, Ca, P) content and enhanced photosynthetic indicators of the plants by 100–200%. A 300% increase in the expression of soybean pathogenesis related GmPR genes encoding antifungal and defense proteins confirmed that the biosynthesized NPs enhanced disease resistance against the fungal phytopathogen. The findings from this study provide novel evidence of systemic suppression of fungal disease by nanobiopesticides, via promoting plant defense mechanisms. © 2023 Elsevier Inc. |
Family-related factors and HIV-related outcomes among Black young men who have sex with men in Mississippi
Barnett AP , Brown LK , Crosby R , Craker L , Washington R , Burns PA , Mena LA . AIDS Behav 2022 1-16 Given their disproportionate HIV incidence, there is a critical need to identify factors related to HIV risk among Black young men who have sex with men (YMSM) in the southeastern United States. This study investigated the association of family factors and HIV-related outcomes among Black YMSM in Mississippi ages 14-20 (n = 72). Multivariable regression models evaluated associations of family factors and outcomes. Greater parent/child communication about sex was associated with fewer lifetime male sex partners and lower odds of lifetime anal sex. Greater parental monitoring was associated with greater likelihood of future condom use. Sexual orientation disclosure was associated with more lifetime male sex partners. Parental monitoring and parent/child communication about sex were protective, suggesting that family-based interventions are promising for HIV prevention among Black YMSM in Mississippi. Results also indicated that YMSM who are "out" to family are important to reach, and families could be useful in encouraging healthy behaviors. |
Telehealth services: Implications for enhancing sexually transmitted infection prevention
Valentine JA , Mena L , Millett G . Sex Transm Dis 2022 49 S36-s40 In the United States, sexually transmitted infections (STIs) are among the most persistent threats to health equity. Increasing access to STI prevention and control services through the provision of Remote Health and Telehealth can improve sexual health outcomes. Telehealth has been shown to increase access to care and even improve health outcomes. The increased flexibility offered by Telehealth services accommodates both patient and provider. Although both Telehealth and Remote Health strategies are important for STI prevention, share common attributes, and, in some circumstances, overlap, this article will focus more specifically on considerations for Telehealth and how it can contribute to increasing health equity by offering an important complement to and, in some cases, substitute for in-person STI services for some populations. Telehealth assists a variety of different populations, including those experiencing STI disparities; however, although the Internet offers a promising resource for many American households and increasing percentages of Americans are using its many resources, not all persons have equal access to the Internet. In addition to tailoring STI programs to accommodate unique patient populations, these programs will likely be faced with adapting services to fit reimbursement and licensing regulations. |
HIV and sexually transmitted infections among persons with Monkeypox - eight U.S. Jurisdictions, May 17-July 22, 2022
Curran KG , Eberly K , Russell OO , Snyder RE , Phillips EK , Tang EC , Peters PJ , Sanchez MA , Hsu L , Cohen SE , Sey EK , Yin S , Foo C , Still W , Mangla A , Saafir-Callaway B , Barrineau-Vejjajiva L , Meza C , Burkhardt E , Smith ME , Murphy PA , Kelly NK , Spencer H , Tabidze I , Pacilli M , Swain CA , Bogucki K , DelBarba C , Rajulu DT , Dailey A , Ricaldi J , Mena LA , Daskalakis D , Bachmann LH , Brooks JT , Oster AM . MMWR Morb Mortal Wkly Rep 2022 71 (36) 1141-1147 High prevalences of HIV and other sexually transmitted infections (STIs) have been reported in the current global monkeypox outbreak, which has affected primarily gay, bisexual, and other men who have sex with men (MSM) (1-5). In previous monkeypox outbreaks in Nigeria, concurrent HIV infection was associated with poor monkeypox clinical outcomes (6,7). Monkeypox, HIV, and STI surveillance data from eight U.S. jurisdictions* were matched and analyzed to examine HIV and STI diagnoses among persons with monkeypox and assess differences in monkeypox clinical features according to HIV infection status. Among 1,969 persons with monkeypox during May 17-July 22, 2022, HIV prevalence was 38%, and 41% had received a diagnosis of one or more other reportable STIs in the preceding year. Among persons with monkeypox and diagnosed HIV infection, 94% had received HIV care in the preceding year, and 82% had an HIV viral load of <200 copies/mL, indicating HIV viral suppression. Compared with persons without HIV infection, a higher proportion of persons with HIV infection were hospitalized (8% versus 3%). Persons with HIV infection or STIs are disproportionately represented among persons with monkeypox. It is important that public health officials leverage systems for delivering HIV and STI care and prevention to reduce monkeypox incidence in this population. Consideration should be given to prioritizing persons with HIV infection and STIs for vaccination against monkeypox. HIV and STI screening and other recommended preventive care should be routinely offered to persons evaluated for monkeypox, with linkage to HIV care or HIV preexposure prophylaxis (PrEP) as appropriate. |
Monkeypox: Avoiding the mistakes of past infectious disease epidemics
Daskalakis D , McClung RP , Mena L , Mermin J . Ann Intern Med 2022 175 (8) 1177-1178 Monkeypox virus, an orthopoxvirus related to the variola virus that causes smallpox, causes a zoonotic disease with an unknown animal reservoir. Clinical manifestations of monkeypox include a prodrome of fever, lymphadenopathy, headache, and malaise 1 to 2 weeks after infection, progressing to a centrifugal rash that includes vesicles and pustules, sometimes numbering in the hundreds or thousands (1). Monkeypox virus infection can be transmitted through cutaneous routes during close or intimate contact with a person whose lesions are not yet crusted over and healed, via fomites that have had contact with a person with monkeypox, and by respiratory droplets among people with close, sustained face-to-face contact. |
Adherence to daily oral TDF/FTC for PrEP in community health center populations: The Sustainable Health Center Implementation PrEP Pilot (SHIPP) Study
Smith DK , Rawlings MK , Glick N , Mena L , Coleman M , Houlberg M , McCallister S , Wiener J . AIDS Behav 2021 26 (2) 350-360 The prevention effectiveness of oral preexposure prophylaxis (PrEP) is highly dependent on medication adherence but no validated longer term PrEP adherence measures are readily available for use by primary care clinicians caring for diverse populations. We compared two self-report measures (number of doses missed in past 7 days and day-by-day past week pill taking) to results of tenofovir concentrations in dried blood spot (DBS) samples at quarterly visits over the first 12 months of PrEP use. 1420 men and women in five US community health centers enrolled in a medication adherence substudy. For 3, 6, 9 and 12 months, the respective percentages of persons with self-report vs DBS levels consistent having taken all 7 doses in the week prior were 71% (51%), 70% (47%), 71% (46%) and 69% (44%). Conversely, the percentage of participants reporting taking 0-1 doses in the week prior by self-report vs DBS drug levels at 3, 6, 9 and 12 months consistent with this level of nonadherence of 6% (9%), 5% (10%), 8% (9%), and 9% (15%). The estimated risk of low adherence (estimated 0-1 doses in the week prior) was higher for participants of Black (RR 1.60, CI 1.09-2.34) or "Other" race (RR 1.62, CI 0.99-2.65) compared with participants of White race; being a transgender female (RR 2.31, CI 1.33-4.02) compared to men who have sex with men; or enrollment at a study site with less experience in the provision of PrEP. The estimated risk of low adherence by DBS was lower for participants with a higher number of sex partners in the past 3 months and those having a bachelor's degree or higher. More work is needed to provide clinicians with measures to assess medication adherence in diverse US populations being prescribed PrEP to support its effective use in reducing HIV acquisition in individuals and at the community level. |
Methods to include persons living with HIV not receiving HIV care in the Medical Monitoring Project
Wei SC , Messina L , Hood J , Hughes A , Jaenicke T , Johnson K , Mena L , Scheer S , Udeagu CC , Wohl A , Robertson M , Prejean J , Chen M , Tang T , Bertolli J , Johnson CH , Skarbinski J . PLoS One 2019 14 (8) e0219996 The Medical Monitoring Project (MMP) is an HIV surveillance system that provides national estimates of HIV-related behaviors and clinical outcomes. When first implemented, MMP excluded persons living with HIV not receiving HIV care. This analysis will describe new case-surveillance-based methods to identify and recruit persons living with HIV who are out of care and at elevated risk for mortality and ongoing HIV transmission. Stratified random samples of all persons living with HIV were selected from the National HIV Surveillance System in five public health jurisdictions from 2012-2014. Sampled persons were located and contacted through seven different data sources and five methods of contact to collect interviews and medical record abstractions. Data were weighted for non-response and case reporting delay. The modified sampling methodology yielded 1159 interviews (adjusted response rate, 44.5%) and matching medical record abstractions for 1087 (93.8%). Of persons with both interview and medical record data, 264 (24.3%) would not have been included using prior MMP methods. Significant predictors were identified for successful contact (e.g., retention in care, adjusted Odds Ratio [aOR] 5.02; 95% Confidence Interval [CI] 1.98-12.73), interview (e.g. moving out of jurisdiction, aOR 0.24; 95% CI: 0.12-0.46) and case reporting delay (e.g. rural residence, aOR 3.18; 95% CI: 2.09-4.85). Case-surveillance-based sampling resulted in a comparable response rate to existing MMP methods while providing information on an important new population. These methods have since been adopted by the nationally representative MMP surveillance system, offering a model for public health program, research and surveillance endeavors seeking inclusion of all persons living with HIV. |
Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial
Kissinger P , Muzny CA , Mena LA , Lillis RA , Schwebke JR , Beauchamps L , Taylor SN , Schmidt N , Myers L , Augostini P , Secor WE , Bradic M , Carlton JM , Martin DH . Lancet Infect Dis 2018 18 (11) 1251-1259 BACKGROUND: Among women, trichomoniasis is the most common non-viral sexually transmitted infection worldwide, and is associated with serious reproductive morbidity, poor birth outcomes, and amplified HIV transmission. Single-dose metronidazole is the first-line treatment for trichomoniasis. However, bacterial vaginosis can alter treatment efficacy in HIV-infected women, and single-dose metronidazole treatment might not always clear infection. We compared single-dose metronidazole with a 7-day dose for the treatment of trichomoniasis among HIV-uninfected, non-pregnant women and tested whether efficacy was modified by bacterial vaginosis. METHODS: In this multicentre, open-label, randomised controlled trial, participants were recruited at three sexual health clinics in the USA. We included women positive for Trichomonas vaginalis infection according to clinical screening. Participants were randomly assigned (1:1) to receive either a single dose of 2 g of metronidazole (single-dose group) or 500 mg of metronidazole twice daily for 7 days (7-day-dose group). The randomisation was done by blocks of four or six for each site. Patients and investigators were aware of treatment assignment. The primary outcome was T vaginalis infection by intention to treat, at test-of-cure 4 weeks after completion of treatment. The analysis of the primary outcome per nucleic acid amplification test or culture was also stratified by bacterial vaginosis status. This trial is registered with ClinicalTrials.gov, number NCT01018095, and with the US Food and Drug Administration, number IND118276, and is closed to accrual. FINDINGS: Participants were recruited from Oct 6, 2014, to April 26, 2017. Of the 1028 patients assessed for eligibility, 623 women were randomly assigned to treatment groups (311 women in the single-dose group and 312 women in the 7-day-dose group; intention-to-treat population). Although planned enrolment had been 1664 women, the study was stopped early because of funding limitations. Patients in the 7-day-dose group were less likely to be T vaginalis positive at test-of-cure than those in the single-dose group (34 [11%] of 312 vs 58 [19%] of 311, relative risk 0.55, 95% CI 0.34-0.70; p<0.0001). Bacterial vaginosis status had no significant effect on relative risk (p=0.17). Self-reported adherence was 96% in the 7-day-dose group and 99% in the single-dose group. Side-effects were similar by group; the most common side-effect was nausea (124 [23%]), followed by headache (38 [7%]) and vomiting (19 [4%]). INTERPRETATION: The 7-day-dose metronidazole should be the preferred treatment for trichomoniasis among women. FUNDING: National Institutes of Health. |
Influenza virus infection causes global RNAPII termination defects.
Zhao N , Sebastiano V , Moshkina N , Mena N , Hultquist J , Jimenez-Morales D , Ma Y , Rialdi A , Albrecht R , Fenouil R , Sanchez-Aparicio MT , Ayllon J , Ravisankar S , Haddad B , Ho JSY , Low D , Jin J , Yurchenko V , Prinjha RK , Tarakhovsky A , Squatrito M , Pinto D , Allette K , Byun M , Smith ML , Sebra R , Guccione E , Tumpey T , Krogan N , Greenbaum B , van Bakel H , Garcia-Sastre A , Marazzi I . Nat Struct Mol Biol 2018 25 (9) 885-893 Viral infection perturbs host cells and can be used to uncover regulatory mechanisms controlling cellular responses and susceptibility to infections. Using cell biological, biochemical, and genetic tools, we reveal that influenza A virus (IAV) infection induces global transcriptional defects at the 3' ends of active host genes and RNA polymerase II (RNAPII) run-through into extragenic regions. Deregulated RNAPII leads to expression of aberrant RNAs (3' extensions and host-gene fusions) that ultimately cause global transcriptional downregulation of physiological transcripts, an effect influencing antiviral response and virulence. This phenomenon occurs with multiple strains of IAV, is dependent on influenza NS1 protein, and can be modulated by SUMOylation of an intrinsically disordered region (IDR) of NS1 expressed by the 1918 pandemic IAV strain. Our data identify a strategy used by IAV to suppress host gene expression and indicate that polymorphisms in IDRs of viral proteins can affect the outcome of an infection. |
National Association of Medical Examiners position paper: Recommendations for the investigation and certification of deaths in people with epilepsy
Middleton O , Atherton D , Bundock E , Donner E , Friedman D , Hesdorffer D , Jarrell H , McCrillis A , Mena OJ , Morey M , Thurman D , Tian N , Tomson T , Tseng Z , White S , Wright C , Devinsky O . Epilepsia 2018 59 (3) 530-543 Sudden unexpected death of an individual with epilepsy can pose a challenge to death investigators, as most deaths are unwitnessed, and the individual is commonly found dead in bed. Anatomic findings (eg, tongue/lip bite) are commonly absent and of varying specificity, thereby limiting the evidence to implicate epilepsy as a cause of or contributor to death. Thus it is likely that death certificates significantly underrepresent the true number of deaths in which epilepsy was a factor. To address this, members of the National Association of Medical Examiners, North American SUDEP Registry, Epilepsy Foundation SUDEP Institute, American Epilepsy Society, and the Centers for Disease Control and Prevention constituted an expert panel to generate evidence-based recommendations for the practice of death investigation and autopsy, toxicological analysis, interpretation of autopsy and toxicology findings, and death certification to improve the precision of death certificate data available for public health surveillance of epilepsy-related deaths. The recommendations provided in this paper are intended to assist medical examiners, coroners, and death investigators when a sudden unexpected death in a person with epilepsy is encountered. |
An integrated electrolysis - electrospray - ionization antimicrobial platform using Engineered Water Nanostructures (EWNS) for food safety applications
Vaze N , Jiang Y , Mena L , Zhang Y , Bello D , Leonard SS , Morris AM , Eleftheriadou M , Pyrgiotakis G , Demokritou P . Food Control 2018 85 151-160 Engineered water nanostructures (EWNS) synthesized utilizing electrospray and ionization of water, have been, recently, shown to be an effective, green, antimicrobial platform for surface and air disinfection, where reactive oxygen species (ROS), generated and encapsulated within the particles during synthesis, were found to be the main inactivation mechanism. Herein, the antimicrobial potency of the EWNS was further enhanced by integrating electrolysis, electrospray and ionization of de-ionized water in the EWNS synthesis process. Detailed physicochemical characterization of these enhanced EWNS (eEWNS) was performed using state-of-the-art analytical methods and has shown that, while both size and charge remain similar to the EWNS (mean diameter of 13 nm and charge of 13 electrons), they possess a three times higher ROS content. The increase of the ROS content as a result of the addition of the electrolysis step before electrospray and ionization led to an increased antimicrobial ability as verified by E. coli inactivation studies using stainless steel coupons. It was shown that a 45-minute exposure to eEWNS resulted in a 4-log reduction as opposed to a 1.9-log reduction when exposed to EWNS. In addition, the eEWNS were assessed for their potency to inactivate natural microbiota (total viable and yeast and mold counts), as well as, inoculated E.coli on the surface of fresh organic blackberries. The results showed a 97% (1.5-log) inactivation of the total viable count, a 99% (2-log) reduction in the yeast and mold count and a 2.5-log reduction of the inoculated E.coli after 45 minutes of exposure, without any visual changes to the fruit. This enhanced antimicrobial activity further underpins the EWNS platform as an effective, dry and chemical free approach suitable for a variety of food safety applications and could be ideal for delicate fresh produce that cannot withstand the classical, wet disinfection treatments. |
Global role and burden of influenza in pediatric respiratory hospitalizations, 1982-2012: a systematic analysis
Lafond KE , Nair H , Rasooly MH , Valente F , Booy R , Rahman M , Kitsutani P , Yu H , Guzman G , Coulibaly D , Armero J , Jima D , Howie SR , Ampofo W , Mena R , Chadha M , Sampurno OD , Emukule GO , Nurmatov Z , Corwin A , Heraud JM , Noyola DE , Cojocaru R , Nymadawa P , Barakat A , Adedeji A , von Horoch M , Olveda R , Nyatanyi T , Venter M , Mmbaga V , Chittaganpitch M , Nguyen TH , Theo A , Whaley M , Azziz-Baumgartner E , Bresee J , Campbell H , Widdowson MA . PLoS Med 2016 13 (3) e1001977 BACKGROUND: The global burden of pediatric severe respiratory illness is substantial, and influenza viruses contribute to this burden. Systematic surveillance and testing for influenza among hospitalized children has expanded globally over the past decade. However, only a fraction of the data has been used to estimate influenza burden. In this analysis, we use surveillance data to provide an estimate of influenza-associated hospitalizations among children worldwide. METHODS AND FINDINGS: We aggregated data from a systematic review (n = 108) and surveillance platforms (n = 37) to calculate a pooled estimate of the proportion of samples collected from children hospitalized with respiratory illnesses and positive for influenza by age group (<6 mo, <1 y, <2 y, <5 y, 5-17 y, and <18 y). We applied this proportion to global estimates of acute lower respiratory infection hospitalizations among children aged <1 y and <5 y, to obtain the number and per capita rate of influenza-associated hospitalizations by geographic region and socio-economic status. Influenza was associated with 10% (95% CI 8%-11%) of respiratory hospitalizations in children <18 y worldwide, ranging from 5% (95% CI 3%-7%) among children <6 mo to 16% (95% CI 14%-20%) among children 5-17 y. On average, we estimated that influenza results in approximately 374,000 (95% CI 264,000 to 539,000) hospitalizations in children <1 y-of which 228,000 (95% CI 150,000 to 344,000) occur in children <6 mo-and 870,000 (95% CI 610,000 to 1,237,000) hospitalizations in children <5 y annually. Influenza-associated hospitalization rates were more than three times higher in developing countries than in industrialized countries (150/100,000 children/year versus 48/100,000). However, differences in hospitalization practices between settings are an important limitation in interpreting these findings. CONCLUSIONS: Influenza is an important contributor to respiratory hospitalizations among young children worldwide. Increasing influenza vaccination coverage among young children and pregnant women could reduce this burden and protect infants <6 mo. |
Estimating the burden of Influenza-associated hospitalizations and deaths in Central America
Descalzo MA , Clara W , Guzman G , Mena R , Armero J , Lara B , Saenz C , Aragon A , Chacon R , El-Omeiri N , Mendez-Rico J , Cerpa M , Palekar R , Jara J , Azziz-Baumgartner E . Influenza Other Respir Viruses 2016 10 (4) 340-5 Influenza is a preventable disease whose burden should be well documented, a necessary step in mobilizing vaccine program staff, providers and influenza vaccine target groups. We estimate the incidence of influenza hospitalizations from five Central America countries. We performed a meta-analysis of influenza-associated hospitalizations and in-hospital deaths. The highest annual incidence was observed among children aged <5 years (136 influenza-associated hospitalizations per 100,000 persons). Annually 7,625-11,289 influenza-associated hospitalizations and 352-594 deaths occurred in the sub-region. Our results suggest that a substantive number of persons are annually hospitalized because of influenza. Health officials should estimate how many illnesses could be averted through increased influenza vaccination. |
Notes from the field: Administration error involving a meningococcal conjugate vaccine - United States, March 1, 2010-September 22, 2015
Su JR , Miller ER , Duffy J , Baer BM , Cano MV . MMWR Morb Mortal Wkly Rep 2016 65 (6) 161-162 Menveo (GlaxoSmithKline, previously Novartis AG) is a conjugate vaccine that was recommended in October 2010 for routine use in adolescents (preferably aged 11 or 12 years, with a booster at 16 years), and among persons aged 2 through 54 years with certain immunosuppressive conditions, to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. These recommendations have since been update. Menveo is supplied in two vials that must be combined before administration. The MenA lyophilized (freeze-dried) component must be reconstituted with the MenCYW-135 liquid component. To administer the vaccine, the liquid component is drawn into a syringe, and used to reconstitute the lyophilized component. The resulting solution is administered by intramuscular injection. Failure to prepare Menveo as directed by the manufacturer's instructions can lead to lack of protection against the intended pathogens (N. meningitidis serogroups A, C, Y, and/or W-135). Recently, an immunization provider administered only the lyophilized component of Menveo, subsequently administered a properly prepared dose of Menveo to the same patient, and asked CDC if this practice was safe. This question prompted CDC to search the Vaccine Adverse Event Reporting System (VAERS) database for reports during March 1, 2010-September 22, 2015, of only one component of Menveo being administered. Additionally, to more broadly identify disproportional reporting of adverse events in general following Menveo immunization compared with other vaccines in VAERS (including errors in vaccine preparation and administration), the Food and Drug Administration performed data mining with empiric Bayesian methods. |
Antibody persistence at 1 and 4 years following a single dose of MenAfriVac or quadrivalent polysaccharide vaccine in healthy subjects aged 2-29 years
Diallo A , Sow SO , Idoko OT , Hirve S , Findlow H , Preziosi MP , Elie C , Kulkarni PS , Parulekar V , Diarra B , Cheick Haidara F , Diallo F , Tapia M , Akinsola AK , Adegbola RA , Bavdekar A , Juvekar S , Chaumont J , Martellet L , Marchetti E , LaForce MF , Plikaytis BD , Enwere GC , Tang Y , Borrow R , Carlone G , Viviani S . Clin Infect Dis 2015 61 Suppl 5 S521-30 BACKGROUND: Mass vaccination campaigns of the population aged 1-29 years with 1 dose of group A meningococcal (MenA) conjugate vaccine (PsA-TT, MenAfriVac) in African meningitis belt countries has resulted in the near-disappearance of MenA. The vaccine was tested in clinical trials in Africa and in India and found to be safe and highly immunogenic compared with the group A component of the licensed quadrivalent polysaccharide vaccine (PsACWY). Antibody persistence in Africa and in India was investigated. METHODS: A total of 900 subjects aged 2-29 years were followed up for 4 years in Senegal, Mali, and The Gambia (study A). A total of 340 subjects aged 2-10 years were followed up for 1 year in India (study B). In study A, subjects were randomized in a 2:1 ratio, and in study B a 1:1 ratio to receive either PsA-TT or PsACWY. Immunogenicity was evaluated by measuring MenA serum bactericidal antibody (SBA) with rabbit complement and by a group A-specific immunoglobulin G (IgG) enzyme-linked immunosorbent assay. RESULTS: In both studies, substantial SBA decay was observed at 6 months postvaccination in both vaccine groups, although more marked in the PsACWY group. At 1 year and 4 years (only for study A) postvaccination, SBA titers were relatively sustained in the PsA-TT group, whereas a slight increasing trend, more pronounced among the youngest, was observed in the participants aged <18 years in the PsACWY groups. The SBA titers were significantly higher in the PsA-TT group than in the PsACWY group at any time point, and the majority of subjects in the PsA-TT group had SBA titers ≥128 and group A-specific IgG concentrations ≥2 microg/mL at any point in time in both the African and Indian study populations. CONCLUSIONS: Four years after vaccination with a single dose of PsA-TT vaccine in Africa, most subjects are considered protected from MenA disease. CLINICAL TRIALS REGISTRATION: PsA-TT-003 (ISRCTN87739946); PsA-TT-003a (ISRCTN46335400). |
Serogroup A meningococcal conjugate (PsA-TT) vaccine coverage and measles vaccine coverage in Burkina Faso - implications for introduction of PsA-TT into the Expanded Programme on Immunization
Meyer SA , Kambou JL , Cohn A , Goodson JL , Flannery B , Medah I , Messonnier N , Novak R , Diomande F , Djingarey MH , Clark TA , Yameogo I , Fall A , Wannemuehler K . Vaccine 2015 33 (12) 1492-8 BACKGROUND: A new serogroup A meningococcal conjugate vaccine (PsA-TT, MenAfriVac) has been developed to combat devastating serogroup A Neisseria meningitis (MenA) epidemics in Africa. A mass immunization campaign targeting 1-29 year olds was conducted in Burkina Faso in December 2010. Protection of subsequent infant cohorts will be necessary through either introduction of PsA-TT into the routine Expanded Programme on Immunization (EPI) or periodic repeat mass vaccination campaigns. OBJECTIVES: To inform future immunization policy for PsA-TT vaccination of infants through a comparison of PsA-TT campaign vaccination coverage and routine measles-containing vaccine (MCV) coverage in Burkina Faso. METHODS: A national survey was conducted in Burkina Faso during December 17-27, 2011 using stratified cluster sampling to assess PsA-TT vaccine coverage achieved by the 2010 nationwide immunization campaign among 2-30 year olds and routine MCV coverage among 12-23 month olds. Coverage estimates and 95% Confidence Intervals (CI) were calculated, reasons for non-vaccination and methods of campaign communication were described, and a multivariable analysis for factors associated with vaccination was conducted. RESULTS: National overall PsA-TT campaign coverage was 95.9% (95% CI: 95.0-96.7) with coverage greater than 90% all 13 regions of Burkina Faso. National overall routine MCV coverage was 92.5% (95% CI: 90.5-94.1), but ranged from 75.3% to 95.3% by region. The primary predictor for PsA-TT vaccination among all age groups was a head of household informed of the campaign. PsA-TT vaccination was more likely in residents of rural settings, whereas MCV vaccination was more likely in residents of urban settings. CONCLUSION: Overall national vaccination rates in Burkina Faso were similar for PsA-TT and MCV vaccine. The regions with MCV coverage below targets may be at risk for sub-optimal vaccination coverage if PsA-TT is introduced in EPI. These results highlight the need for assessments of routine vaccination coverage to guide PsA-TT immunization policy in meningitis belt countries. |
The impact of pre-existing antibody on subsequent immune responses to meningococcal A-containing vaccines
Idoko OT , Okolo SN , Plikaytis B , Akinsola A , Viviani S , Borrow R , Carlone G , Findlow H , Elie C , Kulkarni PS , Preziosi MP , Ota M , Kampmann B . Vaccine 2014 32 (33) 4220-7 Major epidemics of serogroup A meningococcal meningitis continue to affect the African meningitis belt. The development of an affordable conjugate vaccine against the disease became a priority for World Health Organization (WHO) in the late 1990s. Licensing of meningococcal vaccines has been based on serological correlates of protection alone, but such correlates might differ in different geographical regions. If high pre-vaccination antibody concentrations/titers impacts on the response to vaccination and possibly vaccine efficacy, is not clearly understood. We set out to define the pre-vaccination Meningococcal group A (Men A) antibody concentrations/titers in The Gambia and study their impact on the immunogenicity of Men A containing vaccines. Data from subjects originally enrolled in studies to test the safety and immunogenicity of the MenA vaccine recently developed for Africa meningococcal A polysaccharide conjugated to tetanus toxoid, MenAfriVac(R) (PsA-TT) were analyzed. Participants had been randomized to receive either the study vaccine PsA-TT or the reference quadrivalent plain polysaccharide vaccine containing meningococcal groups A, C, W, and Y, Mencevax(R) ACWY, GlaxoSmithKline (PsACWY) in a 2:1 ratio. Venous blood samples were collected before and 28 days after vaccination. Antibodies were assayed by enzyme-linked immunosorbent assay (ELISA) for geometric mean concentrations and serum bactericidal antibody (SBA) for functional antibody. The inter age group differences were compared using ANOVA and the pre and post-vaccination differences by t test. Over 80% of the ≥19 year olds had pre-vaccination antibody concentrations above putatively protective concentrations as compared to only 10% of 1-2 year olds. Ninety-five percent of those who received the study vaccine had ≥4-fold antibody responses if they had low pre-vaccination concentrations compared to 76% of those with high pre-vaccination concentrations. All subjects with low pre-vaccination titers attained ≥4-fold responses as compared to 76% with high titers where study vaccine was received. Our data confirm the presence of high pre-vaccination Men A antibody concentrations/titers within the African meningitis belt, with significantly higher concentrations in older individuals. Although all participants had significant increase in antibody levels following vaccination, the four-fold or greater response in antibody titers were significantly higher in individuals with lower pre-existing antibody titers, especially after receiving PsA-TT. This finding may have some implications for vaccination strategies adopted in the future. |
Fulminant and fatal encephalitis caused by Acanthamoeba in a kidney transplant recipient: case report and literature review
Satlin MJ , Graham JK , Visvesvara GS , Mena H , Marks KM , Saal SD , Soave R . Transpl Infect Dis 2013 15 (6) 619-26 Acanthamoeba is the most common cause of granulomatous amebic encephalitis, a typically fatal condition that is classically described as indolent and slowly progressive. We report a case of Acanthamoeba encephalitis in a kidney transplant recipient that progressed to death within 3 days of symptom onset and was diagnosed at autopsy. We also review clinical characteristics, treatments, and outcomes of all published cases of Acanthamoeba encephalitis in solid organ transplant (SOT) recipients. Ten cases were identified, and the infection was fatal in 9 of these cases. In 6 patients, Acanthamoeba presented in a fulminant manner and death occurred within 2 weeks after the onset of neurologic symptoms. These acute presentations are likely related to immunodeficiencies associated with solid organ transplantation that result in an inability to control Acanthamoeba proliferation. Skin lesions may predate neurologic involvement and provide an opportunity for early diagnosis and treatment. Acanthamoeba is an under-recognized cause of encephalitis in SOT recipients and often presents in a fulminant manner in this population. Increased awareness of this disease and its clinical manifestations is essential to attain an early diagnosis and provide the best chance of cure. |
Identifying optimal vaccination strategies for serogroup A Neisseria meningitidis conjugate vaccine in the African meningitis belt
Tartof S , Cohn A , Tarbangdo F , Djingarey MH , Messonnier N , Clark TA , Kambou JL , Novak R , Diomande FV , Medah I , Jackson ML . PLoS One 2013 8 (5) e63605 OBJECTIVE: The optimal long-term vaccination strategies to provide population-level protection against serogroup A Neisseria meningitidis (MenA) are unknown. We developed an age-structured mathematical model of MenA transmission, colonization, and disease in the African meningitis belt, and used this model to explore the impact of various vaccination strategies. METHODS: The model stratifies the simulated population into groups based on age, infection status, and MenA antibody levels. We defined the model parameters (such as birth and death rates, age-specific incidence rates, and age-specific duration of protection) using published data and maximum likelihood estimation. We assessed the validity of the model by comparing simulated incidence of invasive MenA and prevalence of MenA carriage to observed incidence and carriage data. RESULTS: The model fit well to observed age- and season-specific prevalence of carriage (mean pseudo-R2 0.84) and incidence of invasive disease (mean R2 0.89). The model is able to reproduce the observed dynamics of MenA epidemics in the African meningitis belt, including seasonal increases in incidence, with large epidemics occurring every eight to twelve years. Following a mass vaccination campaign of all persons 1-29 years of age, the most effective modeled vaccination strategy is to conduct mass vaccination campaigns every 5 years for children 1-5 years of age. Less frequent campaigns covering broader age groups would also be effective, although somewhat less so. Introducing conjugate MenA vaccine into the EPI vaccination schedule at 9 months of age results in higher predicted incidence than periodic mass campaigns. DISCUSSION: We have developed the first mathematical model of MenA in Africa to incorporate age structures and progressively waning protection over time. Our model accurately reproduces key features of MenA epidemiology in the African meningitis belt. This model can help policy makers consider vaccine program effectiveness when determining the feasibility and benefits of MenA vaccination strategies. |
Network analysis among HIV-infected young black men who have sex with men demonstrates high connectedness around few venues
Oster AM , Wejnert C , Mena LA , Elmore K , Fisher H , Heffelfinger JD . Sex Transm Dis 2013 40 (3) 206-12 BACKGROUND: Network analysis is useful for understanding sexual transmission of HIV and other sexually transmitted infections. We conducted egocentric and affiliation network analysis among HIV-infected young black men who have sex with men (MSM) in the Jackson, Mississippi, area to understand networks and connectedness of this population. METHODS: We interviewed 22 black MSM aged 17 to 25 years diagnosed as having HIV in 2006 to 2008. Participants provided demographic and geographic information about each sex partner during the 12 months before diagnosis and identified venues where they met these partners. We created affiliation network diagrams to understand connectedness of this population and identify venues that linked participants. RESULTS: The median number of partners reported was 4 (range, 1-16); a total of 97 partners (88 of whom were male) were reported. All but 1 participant were connected through a network of venues where they had met partners during the 12 months before diagnosis. Three venues were named as places for meeting partners by 13 of 22 participants. Participants reported having partners from all regions of Mississippi and 5 other states. CONCLUSIONS: HIV-infected young black MSM in this analysis were linked by a small number of venues. These venues should be targeted for testing and prevention interventions. The pattern of meeting sex partners in a small number of venues suggests densely connected networks that propagate infection. This pattern, in combination with sexual partnerships with persons from outside Jackson, may contribute to spread of HIV and other sexually transmitted infections into or out the Jackson area. |
"Testing-only" visits: an assessment of missed diagnoses in clients attending sexually transmitted disease clinics
Xu F , Stoner BP , Taylor SN , Mena L , Martin DH , Powell S , Markowitz LE . Sex Transm Dis 2013 40 (1) 64-9 BACKGROUND: At sexually transmitted disease (STD) clinics, advances in testing technology coupled with increasing demands and diminishing resources have promoted the use of testing-only visits (clinic visits with testing for STDs but no full examination) to meet increasing demands for STD services. OBJECTIVES: The aims of the present study were to estimate the prevalence of STD diagnoses that could become "missed diagnoses" if patients would use testing-only visits and to examine patient characteristics associated with these potential missed diagnoses. METHODS: We conducted a self-administered survey of STD-related symptoms and sexual risk behaviors in patients seeking routine clinical care at 3 STD clinics. Medical charts were abstracted to estimate the prevalence of viral STDs, trichomoniasis, and other diagnoses from standard clinical services that could become missed diagnoses. RESULTS: Of 2582 patients included, the median age was 24 years and 50% were women. In women, overall, 3.2% were diagnosed as having a viral STD; 9.6%, trichomoniasis; and 41.0%, vulvovaginal candidiasis or symptomatic bacterial vaginosis. The prevalence of these potential missed diagnoses varied by patient characteristics, but in women who reported no symptoms, the prevalence of trichomoniasis was still 6.3%. In men, 19.3% received a diagnosis of urethritis but tested negative for both gonorrhea and chlamydia; this prevalence varied from 15.7% in those who reported no symptoms to 32.6% in those who reported malodor. CONCLUSIONS: A high proportion of STD clients received diagnoses from standard care visits that would be missed by testing-only visits. When patients, even those asymptomatic, use testing-only visits, missed diagnoses of STDs or related genital tract conditions can be substantial. The potential disadvantages of testing-only visits should be weighed against the advantages of such visits. |
Role flexing: how community, religion, and family shape the experiences of young black men who have sex with men
Balaji AB , Oster AM , Viall AH , Heffelfinger JD , Mena LA , Toledo CA . AIDS Patient Care STDS 2012 26 (12) 730-7 While the disproportionate impact of HIV on young black men who have sex with men (MSM) is well documented, the reasons for this disparity remain less clear. Through in-depth interviews, we explored the role of familial, religious, and community influence on the experiences of young black MSM and identified strategies that these young men use to negotiate and manage their sexual minority status. Between February and April 2008, 16 interviews were conducted among HIV-infected and HIV-uninfected young (19- to 24-year-old) black MSM in the Jackson, Mississippi, area. Results suggest that overall, homosexuality remains highly stigmatized by the men's families, religious community, and the African American community. To manage this stigma, many of the participants engaged in a process of "role flexing," in which individuals modified their behavior in order to adapt to a particular situation. The data also provided evidence of internalized homophobia among a number of the participants. The impact of stigma on risk behavior should be more fully explored, and future intervention efforts need to explicitly address and challenge stigma, both among young men themselves and the communities in which they reside. Attention should also be paid to the role masculinity may play as a driver of the HIV epidemic among young black MSM and how this knowledge can be used to inform prevention efforts. |
Missed opportunities for HIV testing in health care settings among young African American men who have sex with men: implications for the HIV epidemic
Dorell CG , Sutton MY , Oster AM , Hardnett F , Thomas PE , Gaul ZJ , Mena LA , Heffelfinger JD . AIDS Patient Care STDS 2011 25 (11) 657-64 Limited health care access and missed opportunities for HIV and other sexually transmitted infection (STI) education and testing in health care settings may contribute to risk of HIV infection. In 2008, we conducted a case-control study of African American men who have sex with men (MSM) in a southeastern city (Jackson, Mississippi) with an increase in numbers of newly reported HIV cases. Our aims were to evaluate associations between health care and HIV infection and to identify missed opportunities for HIV/STI testing. We queried 40 potential HIV-infected cases and 936 potential HIV-uninfected controls for participation in this study. Study enrollees included HIV-infected cases (n=30) and HIV-uninfected controls (n=95) who consented to participate and responded to a self-administered computerized survey about sexual risk behaviors and health care utilization. We used bivariate analysis and logistic regression to test for associations between potential risk factors and HIV infection. Cases were more likely than controls to lack health insurance (odds ratio [OR]=2.5; 95% confidence interval [CI]=1.1-5.7), lack a primary care provider (OR=6.3; CI=2.3-16.8), and to not have received advice about HIV or STI testing or prevention (OR=5.4; CI=1.3-21.5) or disclose their sexual identity (OR=7.0; CI=1.6-29.2) to a health care provider. In multivariate analysis, lacking a primary health care provider (adjusted odds ratio [AOR]=4.5; CI=1.4-14.7) and not disclosing sexual identity to a health care provider (AOR=8.6; CI=1.8-40.0) were independent risk factors for HIV infection among African American MSM. HIV prevention interventions for African American MSM should address access to primary health care providers for HIV/STI prevention and testing services and the need for increased discussions about sexual health, sexual identity, and sexual behaviors between providers and patients in an effort to reduce HIV incidence and HIV-related health disparities. |
Demographic but not geographic insularity in HIV transmission among young black MSM.
Oster AM , Pieniazek D , Zhang X , Switzer WM , Ziebell RA , Mena LA , Wei X , Johnson KL , Singh SK , Thomas PE , Elmore KA , Heffelfinger JD . AIDS 2011 25 (17) 2157-65 OBJECTIVE: To understand patterns of HIV transmission among young black men who have sex with men (MSM) and others in Mississippi. DESIGN: Phylogenetic analysis of HIV-1 polymerase (pol) sequences from 799 antiretroviral-naive persons newly diagnosed with HIV infection in Mississippi during 2005-2008, 130 (16%) of whom were black MSM aged 16-25 years. METHODS: We identified phylogenetic clusters and used surveillance data to evaluate demographic attributes and risk factors of all persons in clusters that included black MSM aged 16-25 years. RESULTS: We identified 82 phylogenetic clusters, 21 (26%) of which included HIV strains from at least one young black MSM. Of the 69 persons in these clusters, 59 were black MSM and 7 were black men with unknown transmission category; the remaining three were MSM of white or Hispanic race/ethnicity. Of these 21 clusters, 10 included residents of one geographic region of Mississippi, whereas 11 included residents of multiple regions or outside of the state. CONCLUSIONS: Phylogenetic clusters involving HIV-infected young black MSM were homogeneous with respect to demographic and risk characteristics, suggesting insularity of this population with respect to HIV transmission, but were geographically heterogeneous. Reducing HIV transmission among young black MSM in Mississippi may require prevention strategies that are tailored to young black MSM and those in their sexual networks, and prevention interventions should be delivered in a manner to reach young black MSM throughout the state. Phylogenetic analysis can be a tool for local jurisdictions to understand the transmission dynamics in their areas. |
Immunogenicity and safety of a meningococcal A conjugate vaccine in Africans
Sow SO , Okoko BJ , Diallo A , Viviani S , Borrow R , Carlone G , Tapia M , Akinsola AK , Arduin P , Findlow H , Elie C , Haidara FC , Adegbola RA , Diop D , Parulekar V , Chaumont J , Martellet L , Diallo F , Idoko OT , Tang Y , Plikaytis BD , Kulkarni PS , Marchetti E , LaForce FM , Preziosi MP . N Engl J Med 2011 364 (24) 2293-304 BACKGROUND: Group A meningococci are the source of major epidemics of meningitis in Africa. An affordable, highly immunogenic meningococcal A conjugate vaccine is needed. METHODS: We conducted two studies in Africa to evaluate a new MenA conjugate vaccine (PsA-TT). In study A, 601 children, 12 to 23 months of age, were randomly assigned to receive PsA-TT, a quadrivalent polysaccharide reference vaccine (PsACWY), or a control vaccine (Haemophilus influenzae type b conjugate vaccine [Hib-TT]). Ten months later, these children underwent another round of randomization within each group to receive a full dose of PsA-TT, a one-fifth dose of PsACWY, or a full dose of Hib-TT, with 589 of the original participants receiving a booster dose. In study B, 900 subjects between 2 and 29 years of age were randomly assigned to receive PsA-TT or PsACWY. Safety and reactogenicity were evaluated, and immunogenicity was assessed by measuring the activity of group A serum bactericidal antibody (SBA) with rabbit complement and performing an IgG group A-specific enzyme-linked immunosorbent assay. RESULTS: In study A, 96.0% of the subjects in the PsA-TT group and 63.7% of those in the PsACWY group had SBA titers that were at least four times as high as those at baseline; in study B, 78.2% of the subjects in the PsA-TT group and 46.2% of those in the PsACWY group had SBA titers that were at least four times as high as those at baseline. The geometric mean SBA titers in the PsA-TT groups in studies A and B were greater by factors of 16 and 3, respectively, than they were in the PsACWY groups (P<0.001). In study A, the PsA-TT group had higher antibody titers at week 40 than the PsACWY group and had obvious immunologic memory after receiving a polysaccharide booster vaccine. Safety profiles were similar across vaccine groups, although PsA-TT recipients were more likely than PsACWY recipients to have tenderness and induration at the vaccination site. Adverse events were consistent with age-specific morbidity in the study areas; no serious vaccine-related adverse events were reported. CONCLUSIONS: The PsA-TT vaccine elicited a stronger response to group A antibody than the PsACWY vaccine. (Funded by the Meningitis Vaccine Project through a grant from the Bill and Melinda Gates Foundation; Controlled-Trials.com numbers, ISRCTN78147026 and ISRCTN87739946.). |
Use of home-obtained vaginal swabs to facilitate rescreening for Chlamydia trachomatis infections: two randomized controlled trials
Xu F , Stoner BP , Taylor SN , Mena L , Tian LH , Papp J , Hutchins K , Martin DH , Markowitz LE . Obstet Gynecol 2011 118 231-9 OBJECTIVE: To determine whether the use of home-based, self-obtained vaginal swabs among women who were treated for Chlamydia infection can increase rescreening rates in comparison with clinic-based rescreening, and to identify subgroups in which rescreening could be enhanced using self-obtained vaginal swabs. METHODS: Two randomized trials were conducted: one with enrollment in sexually transmitted disease (STD) clinics and the other in family planning clinics. Study participants were recruited from STD (n=880) and family planning clinics (n=412) in three cities. Females aged 16 years or older who were treated for Chlamydia infection were randomly assigned to the home group (swab collection kits mailed to home) or the clinic group (made clinic appointments) for rescreening at 3 months after treatment, with reminder calls about 2 weeks before the scheduled rescreening date. RESULTS: Groups were similar with respect to age and other demographic characteristics. Women assigned to the home group had higher rescreening rates than those in the clinic group. In STD clinics, rescreening rates were 26.7% (home) compared with 19.1% (clinic) (P=.01). In family planning clinics, rescreening rates were 40.8% (home) compared with 20.7% (clinic) (P<.001). Among women reached by reminder calls, rescreening rates were also significantly higher in the home groups: 43.5% compared with 33.0% in STD clinic participants and 59.2% compared with 37.8% in family planning clinic participants (both P<.05). The rates of reinfection ranged from 12.9% to 19.4%, and the differences by group were not statistically significant (P≥.3). CONCLUSION: In STD and family planning clinics, use of home-based, self-obtained vaginal swabs resulted in significant increases in rescreening rates compared with rescreening in the clinic. Home-based specimen collection can be an alternative to clinic-based rescreening for Chlamydia infection in women. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT 00132457. LEVEL OF EVIDENCE: I. |
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