HVTN 100

Status:Completed
Phase:I/II
Principal Investigator(s):Linda-Gail Bekker, MBChB, DTMH, DCH, FCP(SA), PhD
Objective:About 252 people will take part in this study at multiple sites. The US National Institutes of Health (NIH) is paying for the study. The investigators are doing this study to answer several questions. Are the study vaccines safe to give to people? Are people able to take the study vaccines without becoming too uncomfortable? How do people's immune systems respond to the study vaccines? (Your immune system protects you from disease.) *Interim results from HVTN 100, presented July, 2016 at the AIDS 2016 in Durban, provided the green light for a Phase III efficacy trial (HVTN 702) on the modified RV144 regimen*   *Trial is in follow-up*   Last updated March 31, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
Description2 recombinant monomeric proteins, each at a dose of 100 mcg, mixed with MF59® adjuvant (an oil-in-water emulsion) delivered as a 0.5 mL IM injection
Mode of DeliveryIntramuscular
ARMsExperimental
Results: Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial.
Official Code: NCT02404311
Related Publications:
Safety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalen
Landscapes of binding antibody and T-cell responses to pox-protein HIV vaccines in Thais and South Africans
Trial Sponsors: Bill & Melinda Gates Foundation, HVTN, Medical Research Council (MRC), NIAID, Novartis Vaccines, Sanofi Pasteur
Start Date
End Date
January 31, 2015
August 31, 2018
Enrollment:252
Age range: 18 Years ↔ 40
Population:Cisgender Men, Cisgender Women