Immunogenicity and safety of ‘Comvigen’, a bivalent SARS-CoV-2 vaccine, in comparison to Comirnaty bivalent vaccine in Thailand: a phase 2, non-inferiority randomised trial
Issued Date
2025-09-01
Resource Type
eISSN
27723682
Scopus ID
2-s2.0-105013667184
Journal Title
Lancet Regional Health Southeast Asia
Volume
40
Rights Holder(s)
SCOPUS
Bibliographic Citation
Lancet Regional Health Southeast Asia Vol.40 (2025)
Suggested Citation
Jantarabenjakul W., Nantanee R., Puthanakit T., Gatechompol S., Avihingsanon A., Punrin S., Tantawichien T., Nitayaphan S., Thitithanyanont A., Buranapraditkun S., Jongkaewwattana A., Ketloy C., Prompetchara E., Lawpoolsri S., Wijagkanalan W., Alameh M.G., Hong L., Samija M., Weissman D., Ruxrungtham K. Immunogenicity and safety of ‘Comvigen’, a bivalent SARS-CoV-2 vaccine, in comparison to Comirnaty bivalent vaccine in Thailand: a phase 2, non-inferiority randomised trial. Lancet Regional Health Southeast Asia Vol.40 (2025). doi:10.1016/j.lansea.2025.100650 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/111829
Title
Immunogenicity and safety of ‘Comvigen’, a bivalent SARS-CoV-2 vaccine, in comparison to Comirnaty bivalent vaccine in Thailand: a phase 2, non-inferiority randomised trial
Author's Affiliation
University of Pennsylvania Perelman School of Medicine
Chulalongkorn University
The Children's Hospital of Philadelphia
Faculty of Science, Mahidol University
Faculty of Tropical Medicine, Mahidol University
King Chulalongkorn Memorial Hospital
Thailand National Center for Genetic Engineering and Biotechnology
Faculty of Medicine, Chulalongkorn University
Thai Red Cross Agency
Armed Forces Research Institute of Medical Sciences, Thailand
The HIV Netherlands Australia Thailand Research Collaboration
BioNet-Asia
Genevant Sciences Corporation
Genevant Sciences GmbH
Chulalongkorn University
The Children's Hospital of Philadelphia
Faculty of Science, Mahidol University
Faculty of Tropical Medicine, Mahidol University
King Chulalongkorn Memorial Hospital
Thailand National Center for Genetic Engineering and Biotechnology
Faculty of Medicine, Chulalongkorn University
Thai Red Cross Agency
Armed Forces Research Institute of Medical Sciences, Thailand
The HIV Netherlands Australia Thailand Research Collaboration
BioNet-Asia
Genevant Sciences Corporation
Genevant Sciences GmbH
Corresponding Author(s)
Other Contributor(s)
Abstract
Background: Strengthening mRNA vaccine development in LMICs is essential for enhancing global pandemic preparedness. This study evaluated the safety and immunogenicity of Comvigen, a bivalent SARS-CoV-2 vaccine, in comparison to the Comirnaty bivalent vaccine (Comirnaty). Methods: This phase II, randomised, open-label, non-inferiority trial was conducted in Thailand across four centres. Participants (n = 450) were randomly assigned (2:1) to receive either Comvigen (50 μg) or Comirnaty (30 μg), using block randomisation (size = 9). Eligible participants had completed at least 2 doses of any approved COVID-19 vaccine, with the last mRNA-vaccine dose given over 3 months before enrolment. The non-inferiority margin of a geometric mean ratio (GMR) of 0.67. The primary immunogenicity endpoint was pseudovirus neutralisation titres (psVNT-50) against SARS-CoV-2 wild-type and Omicron BA.4/BA.5 at Day 29. Safety outcomes included local and systemic adverse reactions up to six months post-vaccination. Immunogenicity analyses were conducted on the Per-Protocol (PP) population and the modified Intent-to-Treat (mITT) population; safety analyses included all participants. Laboratory personnel were blinded to vaccine assignment (ClinicalTrials.gov: NCT05930730). Findings: Between October and November 2023, 450 participants were enrolled (median age of 36 years, IQR 30–45). At day 29, the geometric mean titre (GMT) of psVNT-50 against wild-type virus increased from 475.9 to 2062.9 for Comvigen and from 458.8 to 1905.1 for Comirnaty (GMR 1.1, 95% CI: 1.0–1.2), meeting non-inferiority criteria. Against Omicron BA.4/BA.5, GMTs were 3909.8 for Comvigen and 3288.6 for Comirnaty (GMR 1.2, 95% 1.0–1.4). Local and systemic reactions were more frequent with Comvigen (91% vs. 78%, p = 0.0002, 79% vs. 70%, p = 0.028) but were mild or moderate and transient with no difference in fever (6% vs. 5%, p = 0.84). Interpretation: Comvigen demonstrated non-inferiority immunogenicity to Comirnaty and had a comparable safety profile, supporting mRNA vaccine development for global access and pandemic preparedness. Funding: Covid-19 Pandemic Emergency Fund granted by Thailand's National Economic and Social Development Council provided major funding. Supplementary funding was provided by National Vaccine Institute (NVI), Thailand; Center of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University; Chulalongkorn University Second Century Fund (C2F); BioNet-Asia and Public Donation through Covid-19 vaccine development fund of the Faculty of Medicine, Chulalongkorn University and the Thai Red Cross Society, Thailand.