Ongoing Protocols

All clinical trials done by the HVTN test the safety of vaccine or mAb candidates. We also look at tolerability to see if people have side effects that make them very uncomfortable. We look at the immune responses that are generated in people who receive these vaccines. Our efficacy studies look at whether a vaccine or antibody protects against HIV, or control HIV if infection does occur.

Many of these trials test combinations of products in various doses, schedules, and sequences. For example, does a DNA vaccine followed by a viral vector vaccine generate a different immune response than the same regimen in the reverse order? We may also look at different ways of administering the vaccines, such as using a needle and syringe or needle-free devices.

Publicly Available Data

The HVTN publicly shares datasets from completed trials.  Efficacy trials datasets are described and linked below.  Datasets for phase 1a-2 trials can be found here.

• HVTN 502 (Step) is a phase 2b trial evaluating the MRK Ad5 HIV-1 gag/pol/nef vaccine in 3,000 men and women at high risk of HIV in North America, the Caribbean, South America and Australia.  All public use data are here.
  
  
• HVTN 505 is a phase 2b trial evaluating the DNA/rAd5 HIV-1 vaccine in 2,504 men or transgender women who have sex with men  in the United States.  Data for the primary manuscript are available here.  Data for T cell and antibody correlates analyses are available here.

• HVTN 702 (Uhambo) is a phase 2b/3 trial evaluating the ALVAC-HIV + subtype C gp120/MF59 vaccine in 5,404 men and women at high risk of HIV in South Africa.  Data for the primary manuscript are available here.  Data for correlates analyses are available here.
  
  
• HVTN 703/HPTN 081 and HVTN 704/HPTN 085 (AMP) are two parallel phase 2b trials evaluating passive infusion of the broadly neutralizing antibody VRC01 in 2,699 at-risk cisgender men and transgender persons in the Americas and Europe and 1,924 at-risk women in sub-Saharan Africa. Data for the primary manuscript are available here.  Data for the correlates and sieve analyses are available here.
  

Ancillary/Exploratory Trials

The HVTN shares data and specimens collected in its trials with investigators who would like to answer research questions related to vaccinology, immunology, or HIV/AIDS. These trials are called ancillary/exploratory trials, and the Network invites any researchers to do these trials because it is our belief that collaborative science benefits everyone, including the community. Over the years, the HVTN has collaborated with 173 institutions from around the world in conducting scientific research, including ancillary/exploratory trials.

Ancillary/exploratory trials are a way to make the most of data and samples collected during clinical trials. They also benefit researchers who may not have the resources to collect the required data and specimens on their own, but have the curiosity and drive to ask challenging research questions. By encouraging cooperation with investigators near and far, the HVTN ensures that its trials’ benefits extend far beyond the scope of finding a safe, globally effective HIV vaccine.