1. 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
- Author
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Tomáš Hanke, Carol Smith, Peter Hughes, Jill Gilmour, Annet Nanvubya, Sabina Wakasiaka, Gloria Omosa Manyonyi, Len Dally, Bruce Johnson, Wambui Waruingi, Jane Odada, Omu Anzala, Farah Bashir, Patricia E. Fast, Bhatt Km, Peter Hayes, Mark Boaz, Andrew J. McMichael, Jackton Indangasi, Lucy Matu, Micah Oyaro, Leslie Nielsen, Josephine Birungi, Job J. Bwayo, Tony Tarragona, Andrew Muluubya, Walter Jaoko, Pontiano Kaleebu, C. Schmidt, Carol Konde, H Ogutu, Jeckonia Ndinya-Achola, Frederick N. Nakwagala, Emmanuel Mugisha, and Burc Barin
- Subjects
Adult ,Male ,viruses ,Genetic Vectors ,Epitopes, T-Lymphocyte ,Vaccinia virus ,gag Gene Products, Human Immunodeficiency Virus ,Virus ,DNA vaccination ,Placebos ,Interferon-gamma ,chemistry.chemical_compound ,Vaccines, DNA ,Humans ,Medicine ,Uganda ,Poxviridae ,Orthopoxvirus ,AIDS Vaccines ,General Veterinary ,General Immunology and Microbiology ,biology ,business.industry ,ELISPOT ,Immunogenicity ,Public Health, Environmental and Occupational Health ,Flow Cytometry ,biology.organism_classification ,Kenya ,Virology ,Infectious Diseases ,Chordopoxvirinae ,chemistry ,Immunology ,HIV-1 ,Leukocytes, Mononuclear ,Molecular Medicine ,Female ,Vaccinia ,business ,Plasmids - 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.
- Published
- 2008
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