History of HIV Vaccine Research


HIV was identified as the cause of AIDS. U.S. HHS Secretary Margaret Heckler declared that an AIDS vaccine will be ready for testing within two years.


The first HIV vaccine clinical trial opened at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. This Phase 1 trial enrolled 138 healthy, HIV-negative volunteers. The gp160 subunit vaccine showed no serious adverse effects.


The NIAID AIDS Vaccine Evaluation Group (AVEG), the first U.S. cooperative HIV vaccine clinical trials group, began enrolling volunteers in its first trial.


NIAID launched the first Phase 2 HIV vaccine clinical trial. This trial included HIV-negative volunteers with a history of high-risk behavior -- injection drug use, multiple sex partners, or sexually transmitted infections. Participants were counseled repeatedly to avoid any behaviors that put them at risk of HIV infection.


The first annual HIV Vaccine Awareness Day to honor vaccine study volunteers was observed.

The first large-scale HIV vaccine trial began. VaxGen initiated a Phase 3 trial of AIDSVAX (VAX004) in North America and the Netherlands involving more than 5,400 volunteers.


NIAID began the first African preventive HIV vaccine trial in Uganda.

The first large-scale HIV vaccine trial in a developing country began. VaxGen initiated a Phase 3 trial of AIDSVAX (VAX003) involving over 2,500 volunteers in Thailand.

The newly established Vaccine Research Center (VRC) was dedicated to immunization advocates Dale and Betty Bumpers.


NIAID formed the HIV Vaccine Trials Network (HVTN), a network of clinical sites in the United States and abroad dedicated to developing a preventive HIV vaccine by testing and evaluating candidate vaccines in all phases of clinical trials. The network included more than 25 sites in the United States, Africa, Asia, South America, and the Caribbean.

The first African HIV vaccine trial was completed in Uganda.


The U.S. and Royal Thai governments jointly initiated RV144, a Phase 3 trial to evaluate a novel HIV vaccine strategy commonly referred to as "prime-boost."

Formation of the Global HIV Vaccine Enterprise was proposed in the journal Science.


Both VaxGen candidates failed to confer protection against HIV in Phase 3 trials.


NIAID halted the Phase 2 Step and Phambili studies due to safety concerns.


The Phase 2 HVTN 505 study was initiated to evaluate a “prime-boost” vaccine regimen developed by the VRC.

Results of the Phase 3 Thai Trial (RV144) revealed that the vaccine combination demonstrated a modest preventive effect in humans. The trial, which enrolled more than 16,000 volunteers, was the first, and to date only, large clinical study to demonstrate efficacy for an investigational HIV vaccine.


VRC scientists identified two potent antibodies that neutralize most strains of HIV in the laboratory (VRC01 and VRC02).

The Pox-Protein Public-Private Partnership (P5), an international collaborative team committed to building on the modest success of RV144, was formed.


HVTN 505 was expanded to include protection from HIV as primary endpoint.


Additional analyses of samples from RV144 provided insight into what types of immune responses may be needed for an effective vaccine.


HVTN 505 immunizations were stopped due to lack of efficacy.


The Phase 1/2 HVTN 100 study, part of the P5 research endeavor, launched to test the safety of an experimental HIV vaccine regimen based upon the RV144 findings, as well as its ability to generate an immune response.


NIAID launched the AMP Studies to test whether intravenous infusions of the antibody VRC01 are safe, tolerable and effective at preventing HIV infection. The trials were also designed to answer fundamental scientific questions for HIV prevention and vaccine research.

HVTN 702, part of the P5 research endeavor, launched to test whether a new version of the RV144 HIV vaccine candidate safely prevents HIV infection among adults in South Africa.


NIAID and partners launched Imbokodo or HVTN 705/HPX2008, a Phase 2b proof-of-concept study evaluating the safety and efficacy of an experimental regimen based on a “mosaic” vaccine designed to induce immune responses against a wide variety of global HIV strains.


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