Browsing by Author "Nakwagala, Frederick N."

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    Experiences and practices of key research team members in obtaining informed consent for pharmacogenetic research among people living with HIV: a qualitative study
    (Research Ethics, 2022) Ochieng, Joseph; Kaawa-Mafigiri, David; Munabi, Ian; Nakigudde, Janet; Nabukenya, Sylvia; Nakwagala, Frederick N.; Barugahare, John; Kwagala, Betty; Ibingira, Charles; Twimwijukye, Adelline; Sewankambo, Nelson; Mwaka Sabakaki, Erisa
    This study aimed to explore experiences and practices of key research team members in obtaining informed consent for pharmacogenetics research and to identify the approaches used for enhancing understanding during the consenting process. Data collection involved 15 qualitative, in-depth interviews with key researchers who were involved in obtaining informed consent from HIV infected individuals in Uganda for participation in pharmacogenetic clinical trials. The study explored two prominent themes: approaches used to convey information and enhance research participants’ understanding and challenges faced during the consenting process. Several barriers and facilitators for obtaining consent were identified. Innovative and potentially effective consenting strategies were identified in this study that should be studied and independently verified.
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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
    (Vaccine, 2008) Jaoko, Walter; Nakwagala, Frederick N.; Anzala, Omu; Manyonyi, Gloria Omosa; Birungi, Josephine; Nanvubya, Annet; Ogutu, Hilda; Wakasiaka, Sabina; Matu, Lucy; Odada, Jane; Konde, Carol; Mugisha, Emmanuel; Muluubya, Andrew; Kaleebu, Pontiano
    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-γ) 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.