Kitonsa, Jonathan; Kamacooko, Onesmus; Ruzagira, Eugene; Nambaziira, Florence; Abaasa, Andrew; Serwanga, Jennifer; Gombe, Ben; Lunkuse, Jane; Naluyinda, Hadijah; Tukamwesiga, Naboth; +8 more... Namata, Tamara; Kigozi, Antony; Kafeero, Paddy; Basajja, Vincent; Joseph, Sarah; Pierce, Benjamin F; Shattock, Robin; Kaleebu, Pontiano; (2023) A phase I COVID-19 vaccine trial among SARS-CoV-2 seronegative and seropositive individuals in Uganda utilizing a self-amplifying RNA vaccine platform: Screening and enrollment experiences. Human vaccines & immunotherapeutics, 19 (2). 2240690-. ISSN 2164-5515 DOI: https://doi.org/10.1080/21645515.2023.2240690
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Abstract
We report the screening and enrollment process for a phase I vaccine trial in Masaka, Uganda that investigated the safety and immunogenicity of a self-amplifying SARS-CoV-2 RNA vaccine amongst individuals with and without antibodies to SARS-CoV-2. Participant screening and enrollment were conducted between December 2021 and April 2022. Individuals were eligible if they were aged between 18 and 45 years, healthy, and never vaccinated against COVID-19. SARS-CoV-2 antibody status was determined using two point-of-care rapid tests, i.e. Multi G (MGFT3) and Standard Q (Standard Q COVID-19 IgM/IgG Plus). Data were entered and managed in OpenClinica. Analyses were performed and presented descriptively. A total of 212 individuals were screened and 43(20.3%) enrolled. The most common reasons for exclusion were ≥ grade 1 laboratory abnormalities (39, 18.4%), followed by discordant SARS-CoV-2 antibody results (23, 10.9%). While the first 38 participants were quickly enrolled over a period of 9 weeks, it took another 9 weeks to enroll the remaining five, as antibody negative participants became scarce during the surge of the Omicron variant. The SARS-CoV-2 antibody positivity rate was determined to be 60.8% and 84.4% in each half of the 18 months of screening respectively. The mean age (±Standard Deviation, SD) of screened and enrolled participants was 27.7 (±8.1) and 30.2 (±8.3) years respectively. We demonstrated that it is feasible to successfully screen and enroll participants for COVID-19 vaccine trials in Uganda in the time of a pandemic. Our experiences may be useful for investigators planning to undertake similar work in Africa.
Item Type | Article |
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Faculty and Department |
MRC Uganda > UG-HIV Prevention & Epidemiology MRC Uganda > UG-Uganda Science Support MRC Uganda > UG-HIV Care |
PubMed ID | 37553178 |
Elements ID | 207636 |
Official URL | http://dx.doi.org/10.1080/21645515.2023.2240690 |
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Filename: Kitonsa-etal-2023-A-phase-1-covid-19-vaccine-trial-among-sars-cov-2-seronegative-and-seropositive-individuals.pdf
Licence: Creative Commons: Attribution-Noncommercial 4.0
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