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.

• From: Department for International Development
• Published: 1 January 2008

• Country: Uganda, Kenya
• Document Type: Journal Article
• Theme: Health
• Authors: Nielsen, L., Hughes, P., Kaleebu, P., Birungi, J., Bhatt, K., Anzala, O., Dally, L., Fast, P., Gilmour, J., Jaoko, W., Bwayo, J., Hayes, P., Schmidt, C., Smith, C., Barin, B., Boaz, M., Hanke, T., McMichael, A., Tarragona, T., Indangasi, J., Nanvubya, A., Ndinya-Achola, J., Ogutu, H., Oyaro, M., Wakasiaka, S., Odada, J., Bashir, F., Johnson, B., Konde, C., Manyonyi, G.O., Matu, L., Mugisha, E., Muluubya, A., Nakwagala, F.N., Waruingi, W.

Abstract

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.

Citation

Vaccine (2008) 26 (22) 2788-2795

Links

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.

Published 1 January 2008