Dataset Information

HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL.

ABSTRACT:

Background

HPV antibodies are a marker of past exposure to the virus. Our objective was to assess HPV serostatus pre- and post-vaccination among HIV-negative women.

Methods

Women aged 16-24 years old were randomized in a placebo controlled trial utilizing the 4-valent HPV (4vHPV) vaccine (NCT01489527, clinicaltrials.gov). Participants (n=389) received the 4vHPV vaccine or placebo following a three dose schedule. Sera were collected at Day 1 and Month 7 for assessment of HPV 6, 11, 16, and 18 neutralizing antibody levels using a multiplex competitive Luminex immunoassay (Merck) based on detecting the L1 capsid antigen for each HPV type.

Results

Seroprevalence was 73% for HPV6, 47% for HPV11, 33% for HPV16, and 44% for HPV18. Seroprevalence for any HPV type did not significantly differ by age or lifetime number of partners. The majority of participants (64%) had two or more 4vHPV antibodies present at enrollment and 12% had antibodies to all four. Among women in the vaccine arm, those that were seropositive for HPV16 at enrollment had higher titers at month 7 compared to women that were seronegative for HPV16 at enrollment; this trend holds for the other HPV types as well. Seroconversion among baseline seronegative participants in the placebo group ranged from 5% for HPV16 to 23% for HPV6.

Conclusion

HPV seroprevalence was high in this population, emphasizing the need to vaccinate prior to sexual debut.

SUBMITTER: Sudenga SL

PROVIDER: S-EPMC5417542 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Publications

HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL.

Sudenga Staci L SL Torres B Nelson BN Botha Matthys H MH Zeier Michele M Abrahamsen Martha E ME Glashoff Richard H RH Engelbrecht Susan S Schim Van der Loeff Maarten F MF Van der Laan Louvina E LE Kipping Siegfried S Taylor Douglas D Giuliano Anna R AR

Papillomavirus research (Amsterdam, Netherlands) 20170216

<h4>Background</h4>HPV antibodies are a marker of past exposure to the virus. Our objective was to assess HPV serostatus pre- and post-vaccination among HIV-negative women.<h4>Methods</h4>Women aged 16-24 years old were randomized in a placebo controlled trial utilizing the 4-valent HPV (4vHPV) vaccine (NCT01489527, clinicaltrials.gov). Participants (n=389) received the 4vHPV vaccine or placebo following a three dose schedule. Sera were collected at Day 1 and Month 7 for assessment of HPV 6, 11, ...[more]

PMID: 28480334

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Project description:IntroductionVaccines have proven to be one of the most effective ways to prevent infections. Since the introduction of the Expanded Programme on Immunisation worldwide by WHO in 1974, vaccines have saved more than 150 million lives and prevented countless illnesses and disabilities. In South Africa, vaccination has contributed substantially to the decline in under-five childhood deaths from 89 418 in 2005 to 47 409 in 2013. However, the country still has limitations in achieving optimal uptake of vaccines.MethodsThis study will use a mixed-methods design to identify the factors associated with acceptance, hesitancy and refusal of childhood vaccines in three subdistricts of the Cape Town Metropolitan Health District in South Africa. In phase I of the study, we aim to estimate the uptake of childhood vaccines and assess the factors associated with uptake among a representative sample of at least 236 caregivers of children aged 0-2 years in a cross-sectional study. For phase II of the study, we will explore the behavioural and social drivers of childhood vaccination from the perspective of caregivers of children aged 0-2 years using a purposively selected sample of 20-25 participants from phase I. Finally, for phase III of the study, we will explore the behavioural and social drivers of childhood vaccination from the perspective of 20-25 healthcare workers providing vaccinations to children aged 0-2 years purposively sampled from primary healthcare facilities.Ethics and disseminationEthical approval was obtained from Stellenbosch University (S23/10/232). Various steps will be taken to ensure the anonymity and confidentiality of participants. Findings of the study will be shared with various healthcare stakeholders through conferences and presentations at relevant meetings.ConclusionEvidence from several studies conducted in South Africa shows a significant increase in vaccine hesitancy within the country. The findings of this study will provide insight into the characteristics associated with vaccine acceptance, hesitancy and refusal in Cape Town. The results will help inform the development of evidence-based interventions that can be implemented to improve vaccination coverage.

Project description:The relative feasibility and acceptability of daily versus non-daily dosing of oral HIV pre-exposure prophylaxis (PrEP) among women are unknown. We aimed to investigate the feasibility of non-daily PrEP regimens in adult women.We did a randomised, open-label, phase 2 clinical trial (HPTN 067/ADAPT) of oral PrEP with emtricitabine plus tenofovir disoproxil fumarate at a research centre in Cape Town, South Africa. Participants were adult women (age ?18 years) who received directly observed dosing once a week for 5 weeks followed by random assignment (1:1:1) at week 6 to one of three unblinded PrEP regimens for self-administered dosing over 24 weeks: daily; time-driven (twice a week plus a post-sex dose); or event-driven (one tablet both before and after sex). Primary outcomes were PrEP coverage (at least one dose within the 4 days before sex and one dose within 24 h after sex), pills needed or used to achieve regimen-specific adherence and coverage, and symptoms and side-effects. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01327651; the trial is completed and this report presents the final analysis.Between Sept 12, 2011, and Oct 3, 2012, 191 women were enrolled to the trial. 178 (93%) completed directly observed dosing and were randomly assigned one of the three PrEP regimens for the self-administered phase: 59 were allocated the daily regimen, 59 the time-driven regimen, and 60 the event-driven regimen. Median age of women was 26 years (IQR 21-37; range 18-52). In women allocated the daily regimen, 1459 (75%) of 1952 sex events were covered by PrEP, compared with 599 (56%) of 1074 sex events among those assigned the time-driven regimen (odds ratio [OR] 2·35, 95% CI 1·43-3·83; p=0·0007) and 798 (52%) of 1542 sex events among those allotted the event-driven regimen (2·76, 1·68-4·53; p<0·0001). Fewer pills were needed for complete adherence in women allocated non-daily regimens (vs daily regimen, relative mean 2·53 [95% CI 2·39-2·69] for the time-driven regimen and 4·16 [3·59-4·82] for the event-driven regimen; p<0·0001). Side-effects were uncommon. Eight HIV seroconversions occurred overall, with four documented during the self-administered phase (two with the time-driven regimen and two with the event-driven regimen). Adherence to the assigned regimen was 75% (7283 of 9652 doses taken) for women allocated the daily regimen compared with 65% for those assigned the time-driven regimen (2367 of 3616 doses taken; p=0·0028) and 53% for those allotted the event-driven regimen (1161 of 2203 doses taken; p<0·0001). When sex was reported in the previous week, PrEP drugs were detected (above the lower limits of quantification) more frequently in women assigned the daily regimen (73 [68%] of 107 samples) than in those allocated the time-driven regimen (42 [58%] of 72 samples) and the event-driven regimen (41 [41%] of 99 samples).Daily PrEP dosing resulted in higher coverage of sex events, increased adherence to the regimen, and augmented drug concentrations than did either time-driven or event-driven dosing. These findings support recommendations for daily use of PrEP with oral emtricitabine plus tenofovir disoproxil fumarate in women.HIV Prevention Trials Network.

Dataset Information

HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL.

Background

Methods

Results

Conclusion

Publications

HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL.

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