Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2023
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
_version_ 1785086636829179904
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
work_keys_str_mv AT kitonsajonathan aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT kamacookoonesmus aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT ruzagiraeugene aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT nambaziiraflorence aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT abaasaandrew aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT serwangajennifer aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT gombeben aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT lunkusejane aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT naluyindahadijah aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT tukamwesiganaboth aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT namatatamara aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT kigoziantony aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT kafeeropaddy aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT basajjavincent aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT josephsarah aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT piercebenjaminf aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT shattockrobin aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT kaleebupontiano aphaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT kitonsajonathan phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT kamacookoonesmus phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT ruzagiraeugene phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT nambaziiraflorence phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT abaasaandrew phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT serwangajennifer phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT gombeben phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT lunkusejane phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT naluyindahadijah phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT tukamwesiganaboth phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT namatatamara phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT kigoziantony phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT kafeeropaddy phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT basajjavincent phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT josephsarah phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT piercebenjaminf phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT shattockrobin phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences
AT kaleebupontiano phaseicovid19vaccinetrialamongsarscov2seronegativeandseropositiveindividualsinugandautilizingaselfamplifyingrnavaccineplatformscreeningandenrollmentexperiences