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. 2023 Aug 1;19(2):2240690.
doi: 10.1080/21645515.2023.2240690.

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

Jonathan Kitonsa  1 , Onesmus Kamacooko  1 , Eugene Ruzagira  1 , Florence Nambaziira  1 , Andrew Abaasa  1   2 , Jennifer Serwanga  1 , Ben Gombe  1 , Jane Lunkuse  1 , Hadijah Naluyinda  1 , Naboth Tukamwesiga  1 , Tamara Namata  1 , Antony Kigozi  1 , Paddy Kafeero  1 , Vincent Basajja  1 , Sarah Joseph  3 , Benjamin F Pierce  3 , Robin Shattock  3 , Pontiano Kaleebu  1
Affiliations

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

Jonathan Kitonsa et al. Hum Vaccin Immunother. .

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.

Keywords: COVID-19; SARS-CoV-2; enrolment; screening; self-amplifying RNA; vaccine.

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Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

Figure 1.
Figure 1.
Algorithm for SARS-CoV-2 serology screening in the COVAC Uganda trial.
Figure 2.
Figure 2.
COVAC Uganda screening and enrollment profile.
Figure 3.
Figure 3.
Graph showing reasons for screen failure (some participants had more than one reason for screen failure).
Figure 4.
Figure 4.
Comparison of cumulative screening and enrollment by weeks between (13th Dec 2021 and 13th April 2022).
See this image and copyright information in PMC

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Supplementary concepts