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Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial

Hannawi, Suad, Wu, Xiao-Hong, Villalobos, Ralph Elvi, Burhan, Erlina, Lallaine Borra, Ma. Dovie, Gupta, Rakesh Kumar, Aquitania, Grace P., Ang, Blake Warren C., Mae A. Zabat, Gelza, Roa, Camilo C., Zoleta-De Jesus, Loreta, Yu, Dan-Dan, Wang, Meng, Wu, Yan, Song, Wen-Jie, Ying, Bo, Qin, Cheng-Feng·2024·Med
DOI 10.1016/j.medj.2024.06.013
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Abstract

Background ABO1020 is a monovalent COVID-19 mRNA vaccine. Results from a phase 1 trial showed ABO1020 was safe and well tolerated, and phase 3 trials to evaluate the efficacy, immunogenicity, and safety of ABO1020 in healthy adults are urgently needed. Methods We conducted a multinational, randomized, placebo-controlled, double-blind, phase 3 trial among healthy adults (ClinicalTrials.gov: NCT05636319). Participants were randomly assigned (1:1) to receive either 2 doses of ABO1020 (15 μg per dose) or placebo, administered 28 days apart. The primary endpoint was the vaccine efficacy in preventing symptomatic COVID-19 cases that occurred at least 14 days post-full vaccination. The second endpoint included the neutralizing antibody titers against Omicron BA.5 and XBB and safety assessments. Findings A total of 14,138 participants were randomly assigned to receive either vaccine or placebo (7,069 participants in each group). A total of 366 symptomatic COVID-19 cases were confirmed 14 days after the second dose among 93 participants in the ABO1020 group and 273 participants in the placebo group, yielding a vaccine efficacy of 66.18% (95% confidence interval: 57.21-73.27, p Conclusion ABO1020 was well tolerated and conferred 66.18% protection against symptomatic COVID-19 in adults. Funding National Key Research and Development Project of China, Innovation Fund for Medical Sciences from the CAMS, National Natural Science Foundation of China.

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Research works printed but not linked: 29

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Metadata

Authors
Hannawi, S., Wu, X.-H., Villalobos, R. E., Burhan, E., Lallaine Borra, M. D., Gupta, R. K., Aquitania, G. P., Ang, B. W. C., Mae A. Zabat, G., Roa, C. C., Zoleta-De Jesus, L., Yu, D.-D., Wang, M., Wu, Y., Song, W.-J., Ying, B., & Qin, C.-F.
Venue
Med
Publisher
Elsevier BV
Published
2024-10
Volume
5
Issue
10
Pages
1282-1292.e3
ISSN
2666-6340
DOI
10.1016/j.medj.2024.06.013
Cited by
8
References
7
Language
en
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CoChat. (2026). Citation check: Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial. https://app.cochat.ai/papers/10.1016/j.medj.2024.06.013
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Hannawi, S., Wu, X.-H., Villalobos, R. E., Burhan, E., Lallaine Borra, M. D., Gupta, R. K., Aquitania, G. P., Ang, B. W. C., Mae A. Zabat, G., Roa, C. C., Zoleta-De Jesus, L., Yu, D.-D., Wang, M., Wu, Y., Song, W.-J., Ying, B., & Qin, C.-F. (2024). Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial. Med. https://doi.org/10.1016/j.medj.2024.06.013