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History of NIAID HIV Vaccine Research

1984 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.
1987 The first HIV vaccine clinical trial opened at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. This Phase I trial enrolled 138 healthy, uninfected volunteers. The gp160 subunit vaccine showed no serious adverse effects.
1988 The NIAID AIDS Vaccine Evaluation Group (AVEG), the first U.S. cooperative HIV vaccine clinical trials group, began enrolling volunteers in its first trial.
1992 NIAID launched the first Phase II HIV vaccine clinical trial. This trial included uninfected 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.
1998 First annual HIV Vaccine Awareness Day to honor vaccine study volunteers.

First large scale vaccine trial began: VaxGen initiates Phase III trial of AIDSVAX (VAX004) in North America and The Netherlands involving over 5,400 volunteers.

1999 NIAID begins first African preventive HIV vaccine trial in Uganda.

First large scale vaccine trial in a developing country began: VaxGen initiates Phase III trial of AIDSVAX (VAX003) involving over 2,500 volunteers in Thailand.

Dedication of the Dale and Betty Bumpers Vaccine Research Center (VRC).

2000 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

First African vaccine trial completed in Uganda.

2003 U.S. and Royal Thai governments jointly initiated RV144, a Phase III trial to evaluate a novel HIV vaccine strategy commonly referred to as "prime-boost."

Formation of Global HIV Vaccine Enterprise proposed in Science

2004 Both VaxGen candidates failed to confer protection against HIV in Phase III trials.
2007 NIAID halted the Phase II Step and Phambili studies due to safety concerns.
2009 Phase II HVTN 505 study initiated to evaluate a “prime-boost” vaccine regimen developed by the VRC.

Results of Phase III Thai Trial (RV144) show vaccine combination is first to demonstrate modest preventive effect in humans. The trial enrolled more than 16,000 volunteers.

2010 Two potent antibodies that prevent most strains of HIV identified by the VRC (VRC01 and VRC02).

Establishment of Pox-Protein Public-Private Partnership (P5)

2011 HVTN 505 expanded to include protection from HIV as primary endpoint.
2012 Additional analyses of samples from RV144 provide insight about what type of immune response may be needed for an effective vaccine.
2013 HVTN 505 immunizations stopped due to lack of efficacy.
2015 Phase I/II HVTN 100 study, part of the Pox-Protein Public-Private Partnership (P5), launched to build upon the RV144 results

Last Reviewed September 24, 2015