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

Autor:	Hannawi S; Internal Medicine Department, Al Kuwait-Dubai (Al Baraha) Hospital, Dubai, United Arab Emirates., Wu XH; National Institutes for Food and Drug Control, Beijing, China., Villalobos RE; University of the Philippines - Philippine General Hospital, Manila, Philippines., Burhan E; Department of Pulmonology and Respiratory Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Persahabatan Hospital, Jakarta, Indonesia., Lallaine Borra MD; Clinical Research Department, St. Paul's Hospital of Iloilo, Iloilo, Philippines., Gupta RK; Department of Pulmonology, Lifecare Hospital, Abu Dhabi, United Arab Emirates., Aquitania GP; Davao Medical School Foundation Hospital, Davao, Philippines., Ang BWC; Internal Medicine Department, Manuel J. Santos Hospital, Butuan, Philippines., Mae A Zabat G; William T. Chua Center for Clinical Research, Health Cube Medical Clinics, Mandaluyong, Philippines., Roa CC Jr; Department of Medicine, Medical Center Manila, Manila, Philippines., Zoleta-De Jesus L; Silang Specialists Medical Center, Silang Cavite, Philippines., Yu DD; Abogen Biosciences, Suzhou Abogen Biosciences, Suzhou, China., Wang M; Abogen Biosciences, Suzhou Abogen Biosciences, Suzhou, China., Wu Y; Abogen Biosciences, Suzhou Abogen Biosciences, Suzhou, China., Song WJ; Abogen Biosciences, Suzhou Abogen Biosciences, Suzhou, China., Ying B; Abogen Biosciences, Suzhou Abogen Biosciences, Suzhou, China. Electronic address: bo.ying@abogenbio.com., Qin CF; State Key Laboratory of Pathogen and Biosecurity, Beijing Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences (AMMS), Beijing, China; Research Unit of Discovery and Tracing of Natural Focus Diseases, Chinese Academy of Medical Sciences, Beijing, China. Electronic address: qincf@bmi.ac.cn.
Jazyk:	angličtina
Zdroj:	Med (New York, N.Y.) [Med] 2024 Oct 11; Vol. 5 (10), pp. 1282-1292.e3. Date of Electronic Publication: 2024 Jul 17.
DOI:	10.1016/j.medj.2024.06.013
Abstrakt:	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 < 0.0001). A single dose or two doses of ABO1020 elicited potent neutralizing antibodies against both BA.5 and XBB.1.5. The safety profile of ABO1020 was characterized by transient, mild-to-moderate fever, pain at the injection site, and headache. 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. Competing Interests: Declaration of interests W.-J.S., M.W., Y.W., and D.-D.Y. are employees of Abogen Biosciences. B.Y. is an employee and a board member of Abogen Biosciences. (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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