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Clinical trial of recombinant gag-env HIV1 protein based vaccine VICHREPOL in healthy adults
Presented by Igor Sidorovich, Russian Federation.
Korobova S.1, Nikolaeva I.1, Chevalier A.1, Gornostaeva Y.1, Trubcheniniva L.1, Gorbunova Z.1, Gudima G.1, Pinegin B.1, Chernousov A.1, Petrova T.2, Trofimov D.2, Sidorovich I.1
1Institute of Immunology, Moscow, Russian Federation, 2DNA Tecnology Ltd, Moscow, Russian Federation
Objectives: In spite of the dramatically growth of the new cases of HIV infection the clinical trial only one candidate HIV/AIDS vaccine VICHREPOL has been started in Russia. VICHREPOL is comprised of C-terminal p17, full p24, and immunoreactive fragment of gp41 with polyoxidonium adjuvant. The safety and immunogenicity of candidate vaccine were evaluated.
Methods: 15 male and female participants (2 of them are currently enrolled) aged from 20-40 were recruited. A dose escalation study was conducted to determine the maximum tolerated dose and safety of the vaccine. VICHREPOL were administrated intramuscularly from 2.5 µg to 50 µg at 0, 1, 3, 6 month. Immune response were assessed by virus protein based WB, ELISA and lymphoproliferative assay. Participants were follow-up 6 months after the last immunization.
Results: The vaccine was safe, well tolerated and apyrogenic at all doses. There were no serious adverse events related to the vaccine. The most common vaccine-related adverse events observed was injection site reactions (80%). Vaccination induced both antibody and lymphoproliferative response against both part of vaccine in most participants. The highest antibody level was determine after the forth immunization. The immune response was dose-depended predominantly directed against p24 part.
Conclusions: Preliminary safety data suggest the VICHREPOL was generally safe and well tolerated at all doses studied and induced HIV-specific immune response. The trial will be fully completed at the middle of 2008.
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