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BibTex format

@article{Kitonsa:2025:10.3390/vaccines13060553,
author = {Kitonsa, J and Serwanga, J and Cheeseman, HM and Abaasa, A and Lunkuse, JF and Ruzagira, E and Kato, L and Nambaziira, F and Oluka, GK and Gombe, B and Jackson, S and Ssebwana, JK and McFarlane, LR and Joseph, S and Pierce, BF and Shattock, RJ and Kaleebu, P},
doi = {10.3390/vaccines13060553},
journal = {Vaccines},
title = {Safety and immunogenicity of a modified self-amplifying ribonucleic acid (saRNA) vaccine encoding SARS-CoV-2 spike glycoprotein in SARS-CoV-2 seronegative and seropositive Ugandan individuals},
url = {http://dx.doi.org/10.3390/vaccines13060553},
volume = {13},
year = {2025}
}
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TY  - JOUR
AB  - Background: The COVID-19 pandemic highlighted the need for innovative vaccine platforms that elicit durable immunity. Self-amplifying RNA (saRNA) vaccines offer rapid production and dose-sparing advantages over traditional mRNA platforms. In Uganda’s first SARS-CoV-2 vaccine trial (NCT04934111), we assessed the safety and immunogenicity of a saRNA vaccine encoding the SARS-CoV-2 spike (S) glycoprotein in seronegative and seropositive adults. Methods: This non-randomised phase 1 trial (December 2021–April 2022) enrolled 42 healthy adults (18–45 years), including 12 seronegative and 30 seropositive for SARS-CoV-2. Participants received two 5 μg doses of saRNA vaccine, four weeks apart. Reactogenicity was assessed using diary cards for seven days post-vaccination, and adverse events were monitored throughout the 24-week study. Binding and neutralising antibody levels were quantified using ELISA and pseudovirus neutralisation assays. Findings: The vaccine was well tolerated, with only mild-to-moderate adverse events, including fatigue, headache, and chills. No serious vaccine-related events occurred. Among seronegative participants, 91.6% seroconverted after two doses (median S-IgG: 3695 ng/mL, p < 0.001). In the seropositive participants, S-IgG rose modestly from 7496 to 11,028 ng/mL after the second dose. Neutralising titres increased modestly across WT, BA.2, and A.23.1 variants, with no significant differences between groups. Conclusion: The saRNA SARS-CoV-2 vaccine was safe and immunogenic, inducing robust spike glycoprotein-specific antibody responses, particularly in seronegative participants. This trial demonstrates the potential of saRNA vaccines for broader use.
AU  - Kitonsa,J
AU  - Serwanga,J
AU  - Cheeseman,HM
AU  - Abaasa,A
AU  - Lunkuse,JF
AU  - Ruzagira,E
AU  - Kato,L
AU  - Nambaziira,F
AU  - Oluka,GK
AU  - Gombe,B
AU  - Jackson,S
AU  - Ssebwana,JK
AU  - McFarlane,LR
AU  - Joseph,S
AU  - Pierce,BF
AU  - Shattock,RJ
AU  - Kaleebu,P
DO  - 10.3390/vaccines13060553
PY  - 2025///
SN  - 2076-393X
TI  - Safety and immunogenicity of a modified self-amplifying ribonucleic acid (saRNA) vaccine encoding SARS-CoV-2 spike glycoprotein in SARS-CoV-2 seronegative and seropositive Ugandan individuals
T2  - Vaccines
UR  - http://dx.doi.org/10.3390/vaccines13060553
UR  - https://doi.org/10.3390/vaccines13060553
VL  - 13
ER  -
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