Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection
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
Number of Participants With Desired Effect
Evaluate the efficacy of HPV vaccination, a novel intervention, in the prevention of HIV infection among women residing in South Africa, a country among those with the highest HIV incidence rates internationally.
Anna Giuliano, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|