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The native HIV-1 Tat protein was chosen as vaccine candidate for phase I clinical trials based on its role in the natural infection and AIDS pathogenesis, on the association of Tat-specific immune response with the asymptomatic stage as well as on its sequence conservation among HIV clades.A randomized, double blind, placebo-controlled phase I study (ISS P-001) was conducted in healthy adult volunteers...
A randomized, double blind, placebo-controlled phase I vaccine trial based on the native Tat protein was conducted in HIV-infected asymptomatic individuals. The vaccine was administered five times subcute with alum or intradermally without adjuvant at 7.5μg, 15μg or 30μg doses, respectively. The Tat vaccine was well tolerated both locally and systemically and induced and/or maintained Tat-specific...
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