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.
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.