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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
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...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taylor & Francis
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10411305/ https://www.ncbi.nlm.nih.gov/pubmed/37553178 http://dx.doi.org/10.1080/21645515.2023.2240690 |
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author | Kitonsa, Jonathan Kamacooko, Onesmus Ruzagira, Eugene Nambaziira, Florence Abaasa, Andrew Serwanga, Jennifer Gombe, Ben Lunkuse, Jane Naluyinda, Hadijah Tukamwesiga, Naboth Namata, Tamara Kigozi, Antony Kafeero, Paddy Basajja, Vincent Joseph, Sarah Pierce, Benjamin F. Shattock, Robin Kaleebu, Pontiano |
author_facet | Kitonsa, Jonathan Kamacooko, Onesmus Ruzagira, Eugene Nambaziira, Florence Abaasa, Andrew Serwanga, Jennifer Gombe, Ben Lunkuse, Jane Naluyinda, Hadijah Tukamwesiga, Naboth Namata, Tamara Kigozi, Antony Kafeero, Paddy Basajja, Vincent Joseph, Sarah Pierce, Benjamin F. Shattock, Robin Kaleebu, Pontiano |
author_sort | Kitonsa, Jonathan |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10411305 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Taylor & Francis |
record_format | MEDLINE/PubMed |
spelling | pubmed-104113052023-08-10 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 Kitonsa, Jonathan Kamacooko, Onesmus Ruzagira, Eugene Nambaziira, Florence Abaasa, Andrew Serwanga, Jennifer Gombe, Ben Lunkuse, Jane Naluyinda, Hadijah Tukamwesiga, Naboth Namata, Tamara Kigozi, Antony Kafeero, Paddy Basajja, Vincent Joseph, Sarah Pierce, Benjamin F. Shattock, Robin Kaleebu, Pontiano Hum Vaccin Immunother Coronavirus 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. Taylor & Francis 2023-08-08 /pmc/articles/PMC10411305/ /pubmed/37553178 http://dx.doi.org/10.1080/21645515.2023.2240690 Text en © 2023 The Author(s). Published with license by Taylor & Francis Group, LLC. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent. |
spellingShingle | Coronavirus Kitonsa, Jonathan Kamacooko, Onesmus Ruzagira, Eugene Nambaziira, Florence Abaasa, Andrew Serwanga, Jennifer Gombe, Ben Lunkuse, Jane Naluyinda, Hadijah Tukamwesiga, Naboth Namata, Tamara Kigozi, Antony Kafeero, Paddy Basajja, Vincent Joseph, Sarah Pierce, Benjamin F. Shattock, Robin Kaleebu, Pontiano 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Coronavirus |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10411305/ https://www.ncbi.nlm.nih.gov/pubmed/37553178 http://dx.doi.org/10.1080/21645515.2023.2240690 |
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