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Safety and Immunogenicity of Recombinant Low-Dosage HIV-1 A Vaccine Candidates Vectored by Plasmid pTHr DNA or Modified Vaccinia Virus Ankara (MVA) in Humans in East Africa


Journal Article

W, J.; FN, N.; O, A.; G, O.Manyonyi; J, B.; A, N.; F, B.; K, B.; H, O.; S, W.; L, M.; W, W.; J, O.; M, O.; J, I.; J, N.A.; C, K.; , ; Smith, C.; Barin, B.; Dally, L.; , ; Kaleebu, P.





Adult; AIDS Vaccines; Epitopes- T-Lymphocyte; Female; Flow cytometry; gag Gene Products-Human Immunodeficiency Virus; Genetic Vectors; HIV-1; Interferon-gamma; Kenya; Leukocytes- Mononuclear; Male; Placebos; Plasmids; Uganda; Vaccines-DNA; Vaccinia virus

The safety and immunogenicity of plasmid pTHr DNA, modified vaccinia virus Ankara (MVA) human immunodeficiency virus type 1 (HIV-1) vaccine candidates were evaluated in four Phase I clinical trials in Kenya and Uganda. Both vaccines, expressing HIV-1 subtype A gag p24/p17 and a string of CD8 T-cell epitopes (HIVA), were generally safe and well-tolerated. At the dosage levels and intervals tested, the percentage of vaccine recipients with HIV-1-specific cell-mediated immune responses, assessed by a validated ex vivo interferon gamma (IFN-gamma) ELISPOT assay and Cytokine Flow Cytometry (CFC), did not significantly differ from placebo recipients. These trials demonstrated the feasibility of conducting high-quality Phase 1 trials in Africa.

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