Efficacy, immunogenicity, and safety of heterologous boosting with a novel chimera Chinese mRNA (RQ3013) SARS-CoV-2 vaccine: A randomized, double-blind, active-controlled trial
Issued Date
2025-01-01
Resource Type
ISSN
21645515
eISSN
2164554X
Scopus ID
2-s2.0-105005477668
Pubmed ID
40376714
Journal Title
Human Vaccines and Immunotherapeutics
Volume
21
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Human Vaccines and Immunotherapeutics Vol.21 No.1 (2025)
Suggested Citation
Liu X.Q., Qi Y.Y., Huang T., Huang L.L., Zhao M.X., Wang Z.F., Dai J., Wang Y.X., Chen J.J., Yang X.Y., Fan H.L., Yan X.M., He J.C., Zou Y.X., Jiang Z.W., Zhan Z.F., Tao S.W., Dai D.F., Shi F., Zhang Q.N., Yang X.L., Li X.Z., Li W., Lu J., Zheng J.B., Zhang Z.H., Chen G.X., Su H., Gao W.M., Seidlein L.v., Wang X.Y., Yuan L., Lin J.Z. Efficacy, immunogenicity, and safety of heterologous boosting with a novel chimera Chinese mRNA (RQ3013) SARS-CoV-2 vaccine: A randomized, double-blind, active-controlled trial. Human Vaccines and Immunotherapeutics Vol.21 No.1 (2025). doi:10.1080/21645515.2025.2502250 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/110401
Title
Efficacy, immunogenicity, and safety of heterologous boosting with a novel chimera Chinese mRNA (RQ3013) SARS-CoV-2 vaccine: A randomized, double-blind, active-controlled trial
Author(s)
Liu X.Q.
Qi Y.Y.
Huang T.
Huang L.L.
Zhao M.X.
Wang Z.F.
Dai J.
Wang Y.X.
Chen J.J.
Yang X.Y.
Fan H.L.
Yan X.M.
He J.C.
Zou Y.X.
Jiang Z.W.
Zhan Z.F.
Tao S.W.
Dai D.F.
Shi F.
Zhang Q.N.
Yang X.L.
Li X.Z.
Li W.
Lu J.
Zheng J.B.
Zhang Z.H.
Chen G.X.
Su H.
Gao W.M.
Seidlein L.v.
Wang X.Y.
Yuan L.
Lin J.Z.
Qi Y.Y.
Huang T.
Huang L.L.
Zhao M.X.
Wang Z.F.
Dai J.
Wang Y.X.
Chen J.J.
Yang X.Y.
Fan H.L.
Yan X.M.
He J.C.
Zou Y.X.
Jiang Z.W.
Zhan Z.F.
Tao S.W.
Dai D.F.
Shi F.
Zhang Q.N.
Yang X.L.
Li X.Z.
Li W.
Lu J.
Zheng J.B.
Zhang Z.H.
Chen G.X.
Su H.
Gao W.M.
Seidlein L.v.
Wang X.Y.
Yuan L.
Lin J.Z.
Author's Affiliation
Yunnan Provincial Centers for Disease Control and Prevention
Mahidol Oxford Tropical Medicine Research Unit
School of Life Sciences Fudan University
Shanghai General Hospital
Chinese Center for Disease Control and Prevention
Guangzhou Medical University
Fudan University
Ltd.
Yucheng County Center for Disease Control and Prevention
Guangzhou Customs Technical Center
Yunnan Vaccine Laboratory
Jiaozuo Center for Disease Control and Prevention
Wuyang County Center for Disease Control and Prevention
Baoshan Center for Disease Control and Prevention
Heqing Center for Disease Control and Prevention
Puer Municipal Center for Disease Control and Prevention
Ltd.
Ltd.
Yueyanglou Center for Disease Control and Prevention
Luxi County Center for Disease Control and Prevention
Hunan Center for Disease Control and Prevention
Hengnan County Center for Disease Control and Prevention
Mahidol Oxford Tropical Medicine Research Unit
School of Life Sciences Fudan University
Shanghai General Hospital
Chinese Center for Disease Control and Prevention
Guangzhou Medical University
Fudan University
Ltd.
Yucheng County Center for Disease Control and Prevention
Guangzhou Customs Technical Center
Yunnan Vaccine Laboratory
Jiaozuo Center for Disease Control and Prevention
Wuyang County Center for Disease Control and Prevention
Baoshan Center for Disease Control and Prevention
Heqing Center for Disease Control and Prevention
Puer Municipal Center for Disease Control and Prevention
Ltd.
Ltd.
Yueyanglou Center for Disease Control and Prevention
Luxi County Center for Disease Control and Prevention
Hunan Center for Disease Control and Prevention
Hengnan County Center for Disease Control and Prevention
Corresponding Author(s)
Other Contributor(s)
Abstract
A randomized, double-blind, controlled phase 3 trial was conducted during a COVID-19 outbreak after the initial, stringent zero-Covid policy was relaxed in three provinces. Eligible adults aged ≥18 years who had received three doses of inactivated COVID-19 vaccines 6 months earlier were randomly assigned in a 1:1 ratio to receive either one intramuscular injection of RQ3013 or ZF2001 vaccine. The primary end point was protection against PCR-confirmed symptomatic SARS-CoV-2 infection with onset at least 7 days after the booster. A total of 3,167 and 3,169 eligible participants received one dose of RQ3013 or ZF2001 vaccine, respectively. COVID-19 illness was confirmed in 91 participants in the ZF2001 group (11.8 per 100 person years; 95% confidence interval [CI]: 9.6–14.6) and in 45 participants in the RQ3013 group (5.7 per 100 person-years; 95% CI: 4.3–7.7) during a 4-month follow-up, resulting in a relative efficacy of 51.7% (95% CI, 30.9–66.2%) (p <.001) in an intention-to-treat analysis. The RQ3013 vaccine was also found to be significantly more immunogenic against omicron BA.5 compared to the ZF2001 vaccine. Moderate, transient adverse reaction after vaccination occurred more frequently in the RQ3013 group than in the ZF2001 group. Serious adverse events (SAEs) were rare and occurred almost equally in two groups. All SAEs were not related to the vaccination. These findings suggest that a chimeric mRNA vaccine design involving multiple antigenic epitopes provides broader protection across subvariants and variants of SARS-CoV-2 than the subunit vaccine ZF2001.