Ineffective – HVTN 505 HIV Vaccine Trial Discontinued

hvtn 505 trial stopped nih (kevin dooley)

The National Institute of Allergy and Infectious Diseases (NIAID) has announced that it will halt its HVTN 505 HIV vaccine trial due to a perceived lack of efficacy. A scheduled review by an independent data and safety monitoring board found that the vaccine regimen neither prevented HIV infection nor reduced viral load in vaccine recipients who became infected with HIV.

The announcement will come as a blow to those hoping the HVTN 505 would be an effective intervention to stem the HIV pandemic. However, IAVI CEO Margie McGlynn said ""We know that these trials, even those that do not achieve their goals, play an important role in informing HIV vaccine development."

The prime-boost regimen comprised a DNA-based vaccine candidate and an adenovirus serotype 5-based candidate. The study had been running since 2009, and enrolled over 2500 volunteers from across 19 US cities. There was in fact a non-statistically significant increase in acquisition of HIV among the vaccinated group compared to the placebo group – a total of 41 cases of HIV infection occurred in the volunteers who received the investigational vaccine regimen and 30 cases of HIV infection occurred among the placebo vaccine recipients. The cause of this increase is unknown and is being investigated.

What do you think? Are you surprised or disappointed by the news? You can join our discussion on LinkedIn or leave a comment below, I'd love to hear what you think.

HIV vaccine design and clinical trials were discussed at the World Vaccine Congress USA 2013 – Read more here >> If you want to know more about strategy and innovation in vaccines, you might be interested in attending the World Vaccine Congress Asia 2013, 17-20 June 2013, Singapore.

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Comments 2

  1. Ed Rybicki

    SO sad! There was a lot of optimism around this trial; the fact that it hasn’t worked – and may indeed have caused harm – will be a severe blow to HIV vaccine efforts.

    But the work goes on!

  2. Veljko Veljkovic

    Not surprising. The outcome of this clinical trial was known in advance (see references below)..

    Veljkovic V, Metlas R. Potentially negative effects of AIDS vaccines based on recombinant viruses carrying HIV-1 derived envelope gene. A warning on AIDS vaccine development. Vaccine. 1993;11(3):291-292.

    Veljkovic et al. Molecular basis of the inefficacy and possible harmful effects of AIDS vaccine candidates based on HIV-1 envelope glycoprotein gp120. Vaccine. 1997;15:473-474.

    Veljkovic et al. AIDS epidemic at the beginning of the third millennium: time for a new AIDS vaccine strategy. Vaccine. 2001;19(15-16):1855-1862

    Veljkovic et al. Does VaxGen hide the breakthrough infections? Lancet. 2003; 361(9370):1743-1744.

    Veljkovic et al. AIDSVAX results: an important open question. Vaccine. 2003;21(25-26):3528-3529.

    Veljkovic et al. AIDS vaccine: state of the art at the beginning of the third millennium. Int Rev Immunol. 2004;23(5-6):369-381

    Veljkovic et al. Safety and ethical consideration of AIDS vaccine. Int Rev Immunol. 2004;23(5-6):465-486.

    Veljkovic et al. AIDS vaccine: efficacy, safety and ethics. Vaccine. 2008;26(24):3072-3077.

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