Studies of a prophylactic HIV-1 vaccine candidate based on modified vaccinia virus Ankara (MVA) with and without DNA priming: Effects of dosage and route on safety and immunogenicity

Citation:
Peters BS, Jaoko W, Vardas E, Panayotakopoulos G, Fast P, Klavinskis L, Bogoshi M, Omosa-Manyonyi G, Dally L, Klavinskis L, Farah B, Tarragona T, Bart P-A, Robinson A, Pieterse C, Stevens W, Thomas R, Barin B, McMichael AJ, McIntyre JA, Pantaleo G, Hanke T´aˇs, Bwayo JJ. "Studies of a prophylactic HIV-1 vaccine candidate based on modified vaccinia virus Ankara (MVA) with and without DNA priming: Effects of dosage and route on safety and immunogenicity.". 2006.

Abstract:

Two parallel studies evaluated safety and immunogenicity of a prophylactic HIV-1 vaccine in 192 HIV-seronegative, low-risk volunteers. Modified vaccinia virus Ankara (MVA) and plasmid DNA (pTHr) expressed HIV-1 clade A gag p24 and p17 fused to a string of 25 overlapping CD8+ T cell epitopes (HIVA). Methods: These studies compared intramuscular, subcutaneous, and intradermal MVA at dosage levels ranging from 5×106–2.5×108 pfu. In Study IAVI-010, DNA vaccine was given as a prime at months 0 and 1, followed by MVA as a boost at months 5 and 8. In Study IAVI-011, MVA alone was given at months 0 and 2. Regular safety monitoring was performed. Immunogenicity was measured by the interferon (IFN)- ELISPOT assay on peripheral blood mononuclear cells (PBMC). Results: No serious adverse events were attributed to either vaccine; most adverse events were mild or moderate, although MVA resulted in some severe local reactions. Five vaccine recipients had at least one positive IFN- ELISPOT response, but none were sustained. Conclusion: This HIV-1 vaccine candidate was in general safe and well-tolerated. Local reactions were common, but tolerable. Detectable immune responses were infrequent.

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