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.
- Department for International Development
- 1 January 2008
- Uganda and Kenya
- Document Type:
- Journal Article
- 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., and Waruingi, W.
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.
Vaccine (2008) 26 (22) 2788-2795
Published: 1 January 2008
Document Type: Journal Article
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.