To date, the Network has conducted the majority of the published, presented, or ongoing clinical trials of preventive HIV vaccines worldwide. In the process, we have gained tremendous experience in implementing an innovative global scientific organization, which combines the intellectual robustness and creativity of academia with the focus and infrastructure of industry.
The HVTN is comprised of the Leadership and Operations Center (LOC), Laboratory Center (LC), Statistical and Data Management Center (SDMC), study clinics , and participants and communities. Each of these components is necessary to conduct our clinical trials.
One unique advantage of the Network is the vast collection of samples and data from all studies that allows us to compare and contrast cross-study results. We can then decide which vaccine regimens are worth pursuing versus those that are not as promising. By sharing these data with other researchers, we help the entire HIV prevention effort move forward.
The Executive Management Team (EMT) provides the day-to-day leadership and decision-making for the HVTN and is the focus of coordination among the LOC, LC, SDMC and study clinics. The Scientific Governance Committee (SGC) provides scientific, administrative, fiscal and programmatic leadership and governance for our Network. This 24-person committee encompasses important constituents from across the HVTN, including Network leadership, investigators and committee chairs, DAIDS representatives, community representatives and external advisors. HVTN leadership relies on 6 advisory boards to provide feedback and guidance on Network performance, strategic scientific and operational issues, and community questions. Eight committees and working groups serve as forums for ideas and expertise that inform the Network’s scientific productivity. Importantly, regional LOC staff work overseas to support the efficacy trials and increase in-country capacity development.
The HVTN vaccine pipeline is currently focused on vaccine regimens that elicit broadly neutralizing antibody (bnAb) responses. An antibody that neutralizes HIV binds to proteins on the surface of the virus and blocks HIV’s ability to bind and infect CD4+ T cells. Neutralizing antibodies are considered ‘broad’ by their ability to neutralize multiple strains of HIV. Recent technological advances have accelerated progress in the isolation and characterization of several different classes of HIV-specific bnAbs. With that information in hand, we can design vaccines that specifically stimulate the production of those bnAbs.
In recent years, the HVTN has paved the way in studying a technique called passive antibody transfer, which involves giving antibodies directly to an HIV-negative person by injections or infusions. Through the AMP Studies, the HVTN determined a broadly neutralizing antibody called VRC01 was effective at preventing the acquisition of HIV to 75 percent of HIV strains that were sensitive to the bnAb. This work has led to further study of combinations of bnAbs that may be more potent or have greater breadth of neutralization.
In partnership with the AIDS Clinical Trials Group (ACTG) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), the HVTN is conducting an integrated clinical trials program including immunological, microbiological, and diagnostic technologies to enhance the TB vaccine field globally by evaluating the safety and immunogenicity of TB vaccines.
As the SARS-CoV-2/COVID-19 pandemic began, the HVTN was asked to apply its community engagement, clinical, statistical, and operational infrastructure to rapidly implement and analyze the U.S. government-supported Phase 3 clinical trials of COVID-19 vaccines. The COVID-19 Prevention Network (CoVPN), funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), was formed in spring 2020 to create a coordinated, efficient and scientifically rigorous approach to conduct COVID-19 vaccine efficacy trials and help end the pandemic.
The HVTN recognizes the importance of public support in finding a vaccine against HIV. Our staff and volunteers from around the globe work actively to help community members understand the science of HIV/AIDS vaccines, as well as research methods and clinical trial processes. Through our efforts, we hope to dispel some of the misconceptions that surround HIV/AIDS and studies involving human participants.
Funding is provided by public and private sources. The NIAID, part of the NIH, an agency of the U.S. Department of Health and Human Services (DHHS), is our main funder and the sponsor of most of our trials. Another significant funding source is the Bill & Melinda Gates Foundation. The Network and our partners have a close, cooperative working relationship, with shared attention to intellectual and scientific issues.
The Network’s clinical research sites are located at leading research institutions in over in 16 countries on four continents. Internationally renowned researchers in HIV vaccines and prevention lead these units and contribute to the Network’s scientific agenda. The Network’s headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington.
Vaccine Developers: The HVTN does not develop vaccine candidates ourselves. We rely on the expertise of others, who bring their products to us to test in clinical trials. Our developers include biotech companies, academic institutions, pharmaceutical companies, and the NIH – representing the best the scientific community has to offer.
Funders: The HVTN is supported through a cooperative agreement with the Division of AIDS (DAIDS) at NIAID, part of the NIH. We are proud to be one of four research networks funded by DAIDS. We are also grateful for partnerships with the Bill & Melinda Gates Foundation, which have enabled us to scale up our efforts in southern Africa for larger efficacy trials.
Communities: Since its formation in 1999, the HVTN has incorporated communities into all aspects of our work. In addition to local Community Advisory Boards (CABs) at each clinical research site, community members serve on Network committees and are part of Network governance. The HVTN follows the principals of Good Participatory Practice. We rely on input from members of the community to help ensure that our trials follow the highest standards of research ethics and are relevant to the communities that participate in our studies.
Regulators and Ethicists: The HVTN follows the regulations of every country in which we conduct our research and we work closely with each of the national regulatory agencies. All of our studies go through layers of regulatory review including at the local and national levels. As new issues in HIV prevention arise, we consult with experts in the field of research ethics.
Participants/Volunteers: These individuals are the true heroes in the HVTN! Scientists cannot do this work by themselves. We rely on the people who join a clinical trial, the members of our local and global CABs, and all who help spread the message about the hope offered by a preventive vaccine against HIV. Without this support, HIV vaccine research could not move forward.