HVTN 702/Uhambo efficacy trial is halted early following an interim analysis due to non-efficacy.
HVTN LOC, LC and SDMC are recruited by the US government to use their expertise in conducting HIV vaccine trials to help operationalize five largescale (30,000 persons each) efficacy trials of COVID-19 vaccines.
HVTN has almost 15,000 participants enrolled in its trials.
HVTN and collaborators publish a meta-analysis of nonhuman primate monoclonal antibody studies that shows neutralizing activity in serum at the time of challenge was the main determinant of protection from infection.
HVTN and South African Medical Research Council, with additional support from the Fred Hutch and industry partners, set up a PrEP fund for drug acquisition and laboratory monitoring for HIV prevention studies across sub-Saharan Africa. Reference Miner, et al, Trials, 2021)
HVTN launches the HVTN 705/Imbokodo Study, in collaboration with Janssen, in five sub-Saharan African countries to test the efficacy of an experimental mosaic vaccine designed to protect against global HIV subtypes. The goal of the Imbokodo study is to prompt a broad immune response that would be effective worldwide, regardless of circulating subtype.
HVTN, in collaboration with the HIV Prevention Trials Network (HPTN), initiates the Antibody Mediated Prevention (AMP) test-of-concept trials, the first efficacy trials of a monoclonal antibody (VRC01) to prevent HIV acquisition. The two trials are conducted in 11 countries.
HVTN opens a pivotal Phase 2b/3 HIV vaccine efficacy trial in South Africa. HVTN 702 evaluates a regionally-modified version of the RV144 vaccine to target subtype C strains that predominate in southern Africa.
HVTN demonstrates that people in South Africa respond with equivalent immune responses as people in Thailand to the modestly protective RV144 vaccine. These results pave the way for follow up HIV vaccine trials in southern Africa.
HVTN discovers that polyfunctional T helper cells could predict vaccine efficacy in the RV144 vaccine trial.
HVTN expands its clinical research site network to include over two dozen new CRSs with corresponding clinician researchers, local communities, laboratory staff, and pharmacists.
HVTN successfully renews its 7-year grant and funding from the NIH.
HVTN scientists develop new statistical and analytical methods to evaluate HIV vaccine T-cell response profiles more comprehensively.
Results related to HVTN studies have been published in more than 300 manuscripts in peer-reviewed scientific journals.
Under the auspices of the Hutchinson Center Research Institute of South Africa, the new Cape Town HVTN Immunology Laboratory (CHIL) is officially unveiled. CHIL is a state-of-the-art facility created to increase the efficiency of laboratory assessment for future efficacy trials, while developing local scientists and local capacity in specialized clinical trial assays.
HVTN LC develops a set of antibody assays with high reproducibility that provides a more comprehensive understanding of the characteristics and functions of effective antibodies. These assays were used to obtain many of the informative results from the RV144 vaccine trial.
The HVTN Initiatives Program is established to work collaboratively with investigators utilizing previously collected trial data and specimens. The program results in significant scientific contributions that include cutting-edge basic science research and sophisticated cross study analyses.
A social and behavioral science initiative is launched and brings new qualitative research expertise to the HVTN.
HVTN researchers and affiliates contribute to a landmark analysis that demonstrates for the first time that vaccination with an experimental vaccine could put immunological pressure on HIV.
HVTN LC develops and validates a binding multiplex antibody assay (BAMA) to assess levels and specificity of antibodies binding to HIV envelope protein.
HVTN LC and SDMC collaborate with the US Military HIV Research Program and the Thai government to examine potential immune responses correlating with infection risk in the RV144 HIV vaccine efficacy trial, the first HIV vaccine trial to show some effectiveness in preventing HIV infection.
An unprecedented collaboration known as the Pox Protein Public Private Partnership, or P5, is initiated. Its primary aim is to extend and confirm the RV144 findings in other geographical locations, such as southern Africa, and to prepare a path to potential vaccine licensure.
The HVTN establishes three training and mentorship programs aimed to recruit and retain the next generation of HIV prevention researchers to ensure the continuation of scientific advances in HIV vaccine research.
A novel Phase 2b adaptive trial design is developed to use statistical power to obtain early efficacy evaluations in smaller trials than traditionally used. Since its development, the model has gained favor by many in the HIV vaccine field over the traditional use of Phase 3 trials.
HVTN launched a Phase 2b efficacy trial, HVTN 505, in the U.S. to evaluate a DNA prime, Ad5 boost vaccine regimen in men and transgender women who have sex with men.
HVTN reaches out to colleagues in the scientific community for research proposals to investigate key scientific questions following the release of the Step Study efficacy results, ultimately funding and/or providing specimens for over 25 studies that followed-up on the Step Study results. Outcomes from these collaborative projects altered the vaccine design and development field moving forward.
HVTN LC, SDMC, and Merck laboratories conduct a technology transfer and concordance study to further optimize and validate the ELISpot assay used to measure HIV-specific T cells.
HVTN LC validates its intracellular cytokine staining assay that allows for better characterization of cellular responses. This assay can be used across countries and regions in preventive vaccine trials and with other clinical trials networks.
HVTN successfully renews its 7-year grant and funding from the NIH.
The Legacy Project, a program pioneered by the HVTN, is created to engage historically under-represented populations and build trust between researchers and communities of color. The success of the program led NIAID to expand it to all of its HIV clinical trials networks. Leadership for the Legacy Project is now provided through the Office of HIV/AIDS Network Coordination.
To address characteristics unique to the preventive HIV vaccine setting, the HVTN Statistical and Data Management Center (SDMC) develops a novel approach to evaluate vaccine candidates for early phase trials that efficiently identifies the most promising vaccine candidates for further study in efficacy trials.
HVTN scientists develop and validate an assay to measure the ability of vaccine-elicited antibodies to neutralize different HIV isolates. The neutralizing antibody assay developed at the HVTN has been widely used in clinical trials and preclinical studies evaluating experimental HIV vaccines.
HVTN launches HVTN 050 (Merck 018), a global vaccine trial spanning eight countries and five regions.
A commitment is made to ensure antiretroviral therapy (ART) is available to study participants who become infected with HIV.
A fund is established to help ensure that participants receive ART if it is not otherwise available through a national program.
HVTN Laboratory Center (LC) develops a qualified interferon gamma ELISpot assay to measure HIV-specific T cells elicited in HIV vaccine study participants.
HVTN LC validates an ELISA assay to assess vaccine-induced antibody responses in HIV vaccine study participants.
HVTN develops an efficient protocol development process that includes thorough scientific, government, community, and regulatory review and approval. Elements of this process have since been used by other organizations.
HVTN statisticians and their collaborators develop a novel statistical method called 'sieve analysis,' which identifies viral sequences that differ between vaccine and placebo recipients who became infected with HIV. The implication is that the vaccine put immune pressure on certain viral strains.
HIV Vaccine Trials Network awarded grant from the National Institutes of Health to integrate clinical development of experimental HIV vaccines in a network structure and conduct vaccine studies worldwide with consistent clinical, laboratory, and statistical standards and procedures that allow comparisons across experimental vaccines.