Sexual Transmission of Infection Clinical Trial
Official title:
Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection
Moffitt Cancer Center is the Coordinating Center for this study.
The purpose of this study is to develop and test the infrastructure to conduct a future
Phase III vaccine efficacy trial to assess trial feasibility, and to assess human
papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. The
investigators propose to conduct a Preparedness study among women ages 16-24 years of age
residing in a region of South Africa with a high human immunodeficiency (HIV) incidence and
prevalence.
The specific aims of this study are to:
1. Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm,
400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18
[Gardasil]) or placebo vaccine.
2. Determine the cervical HPV prevalence and type distribution at enrollment, and cervical
lesion prevalence among young females ages 16-24 years at high risk for HIV infection.
3. Assess the rate of compliance through the 3-dose vaccination series
The study vaccine will be blindly administered as supplied on Day 1, Month 2, and Month 6. Both HPV and placebo vaccines will be in identical bottles, and all treatment codes will be kept under lock and key. All vaccines will be injected intramuscularly into the deltoid muscle by a member of the clinical staff. Each participant will be monitored for systemic and local reactions for 30 minutes postvaccination after each study vaccination for any adverse effects, including allergic reactions. Vaccine adverse events will continue to be monitored throughout the duration of the study period. Vaccine will be shipped to a central pharmacy at Stellenbosch University and stored in a refrigerator monitored and maintained at 2-8 C prior to distribution and local storage at participating clinical centers. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01575938 -
HIV Prevention Intervention for Young Transgender Women
|
N/A |