The New York–based International AIDS Vaccine Initiative (IAVI) denies that it violated ethics by testing a US-made HIV vaccine in India, even though it already knew the vaccine had failed to protect trial participants in Europe. The vaccine, tgAAC09, uses an adeno-associated viral vector and was developed by Targeted Genetics, of Seattle, which conceded in early 2005 that the vaccine did not “elicit significant immune responses at the doses evaluated” in Germany and Belgium. The IAVI-sponsored trial involved 30 volunteers recruited by India's National AIDS Research Institute (NARI) in Pune. The Indian Council of Medical Research (ICMR) stopped the trial in December, saying the vaccine gave “poor” immune responses. Critics have questioned IAVI's rationale for continuing the trial after knowing that only 20% of volunteers in Europe responded to the vaccine. Antara Sinha, IAVI spokesperson, points out that European trial results were communicated promptly to ICMR and the trial continued only after clearance from NARI's ethics committee. IAVI claimed the trial was justified because “the safety and immunogenicity among Indian and European volunteers may be completely different” owing to ethnicity and genetic factors, and the ICMR says the volunteers were fully informed about the European data and given the option to withdraw. Indeed, IAVI has now clarified that no trial participants tested seropositive for HIV. KSJ
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11 July 2008
In the version of this article initially published, the author reported that “trial participants now test seropositive for HIV and are 'unable to convince their employers that their HIV status was vaccine induced'.” In fact, none of the trial participants tested positive for HIV. The error has been corrected in the HTML and PDF versions of the article.
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Jayaraman, K. HIV vaccine controversy. Nat Biotechnol 26, 256 (2008). https://doi.org/10.1038/nbt0308-256a
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DOI: https://doi.org/10.1038/nbt0308-256a
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