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news.The US National Institute of Allergy and Infectious Diseases, part of the NIH, has cancelled a large Phase IIb study planned for the development of a novel HIV vaccine. In its place the institute intends to begin a smaller study, according to Scrip World Pharmaceutical News.
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The US National Institute of Allergy and Infectious Diseases (NIAID) said that it had scrapped the trial because of uncertainties over the underlying science.
According to NIAID, the original Pave 100 study had planned to enrol 8,500 volunteers in the US, South America, the Caribbean and Africa. The main objectives of the study were to see whether the vaccine prevented HIV-1 infection and whether vaccination results in decreased viral load if volunteers become infected by HIV despite vaccination.
The study was to begin US recruitment in October 2007 however, the failure of Merck & Co’s similar Phase II HIV vaccine trial, which was co-sponsored by the NIAID, led to its postponement.
Later Pave 100 was reduced in scope to test the Vaccine Research Center (VRC) vaccine in 2,400 gay men in the US. Specifically, the men were to be circumcised and not to have pre-existing neutralising antibodies to adenovirus type 5 (Ad5), the common cold virus used in the vaccine as a carrier for the HIV genes. The redesigned Pave 100 study would have tested the vaccine’s effect on viral load and examined the immune responses to the vaccine and their impact on viral load.
NIAID is now planning to initiate a smaller, more focused trial with the VRC vaccine to find out whether the product has a significant effect on HIV viral load. This small study will demonstrate whether the vaccine will prevent HIV infection and would be large enough to detect a robust signal of VRC’s effect on viral load.
If such an effect is noticed, NIAID will carry on additional studies or an expansion of the study to determine whether immunological correlates (to see how the immune responses relate to effect on viral load) can be performed.