HVTN 505

HVTN 505 is a clinical trial testing an HIV vaccine regimen on research participants. The trial is conducted by the HIV Vaccine Trials Network and sponsored by the National Institute of Allergy and Infectious Diseases. Vaccinations were stopped in April 2013 due to initial results showing that the vaccine was ineffective in preventing HIV infections and lowering viral load among those participants who had become infected with HIV. All study participants will continue to be monitored for safety and any long-term effects.

The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the HIV Vaccine Trials Network (HVTN) is conducting the trial. The Vaccine Research Center (VRC) developed the vaccines being researched in the trial. The research sites were in the following places:

HVTN 505 is being conducted to determine the safety and efficacy of a Vaccine Research Center DNA/rAd5 vaccine regimen in healthy males and male-to-female transgender persons who have sex with men. All participants must be fully circumcised, and must have no evidence of previous infection with Adenovirus 5, which is a common virus that causes colds and respiratory infections. Potential participants were tested for antibodies to Adenovirus 5 as part of the screening process to determine their eligibility.

When the study began the primary outcome being measured was whether the vaccine decreased the viral load, which is amount of HIV in the blood of study participants who received the vaccine then later became infected with HIV. At that time, researchers stated that the vaccine was very unlikely to provide any protection from HIV infection. In August 2011 because of new data from other clinical trials, NIAID shifted the focus of the study to determine whether vaccination was also able to prevent HIV infection. As a result of this change to the research questions, NIAID also announced an expansion in the desired enrollment to a total of 2200 participants. The study was further expanded to 2500 participants in 2012 to ensure that there would be enough data to meaningfully answer the research questions.

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