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
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 ass...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2025-12-01
|
| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2502250 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849727846293962752 |
|---|---|
| author | Xiao-Qiang Liu Yang-Yang Qi Tao Huang Li-Li Huang Ming-Xuan Zhao Zhong-Fang Wang Jun Dai Yan-Xia Wang Jing-Jing Chen Xiao-Yun Yang Hui-Lan Fan Xue-Mei Yan Jian-Chang He Yan-Xiang Zou Zhi-Wei Jiang Zhi-Fei Zhan Si-Wen Tao De-Fang Dai Feng Shi Qiong-Na Zhang Xiu-Liang Yang Xiao-Zhong Li Wei Li Jing Lu Jiang-Bing Zheng Zhi-Hua Zhang Gao-Xiang Chen Hong Su Wei-Min Gao Lorenz von Seidlein Xuan-Yi Wang Lin Yuan Jin-Zhong Lin |
| author_facet | Xiao-Qiang Liu Yang-Yang Qi Tao Huang Li-Li Huang Ming-Xuan Zhao Zhong-Fang Wang Jun Dai Yan-Xia Wang Jing-Jing Chen Xiao-Yun Yang Hui-Lan Fan Xue-Mei Yan Jian-Chang He Yan-Xiang Zou Zhi-Wei Jiang Zhi-Fei Zhan Si-Wen Tao De-Fang Dai Feng Shi Qiong-Na Zhang Xiu-Liang Yang Xiao-Zhong Li Wei Li Jing Lu Jiang-Bing Zheng Zhi-Hua Zhang Gao-Xiang Chen Hong Su Wei-Min Gao Lorenz von Seidlein Xuan-Yi Wang Lin Yuan Jin-Zhong Lin |
| author_sort | Xiao-Qiang Liu |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-bb073bb5b4f2440baeacfc86cd666224 |
| institution | DOAJ |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-bb073bb5b4f2440baeacfc86cd6662242025-08-20T03:09:44ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2502250Efficacy, immunogenicity, and safety of heterologous boosting with a novel chimera Chinese mRNA (RQ3013) SARS-CoV-2 vaccine: A randomized, double-blind, active-controlled trialXiao-Qiang Liu0Yang-Yang Qi1Tao Huang2Li-Li Huang3Ming-Xuan Zhao4Zhong-Fang Wang5Jun Dai6Yan-Xia Wang7Jing-Jing Chen8Xiao-Yun Yang9Hui-Lan Fan10Xue-Mei Yan11Jian-Chang He12Yan-Xiang Zou13Zhi-Wei Jiang14Zhi-Fei Zhan15Si-Wen Tao16De-Fang Dai17Feng Shi18Qiong-Na Zhang19Xiu-Liang Yang20Xiao-Zhong Li21Wei Li22Jing Lu23Jiang-Bing Zheng24Zhi-Hua Zhang25Gao-Xiang Chen26Hong Su27Wei-Min Gao28Lorenz von Seidlein29Xuan-Yi Wang30Lin Yuan31Jin-Zhong Lin32Immunization Planning Unit, Yunnan Center for Disease Control and Prevention, Kunming, People’s Republic of ChinaShanghai Institute of Infectious Disease and Biosecurity, Fudan University, Shanghai, People’s Republic of ChinaImmunization Planning Unit, Hunan Center for Disease Control and Prevention, Changsha, People’s Republic of ChinaImmunization Planning Unit, Henan Center for Disease Control and Prevention, Zhengzhou, People’s Republic of ChinaClinical Research, First People’s Hospital, Shanghai, People’s Republic of ChinaState Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, People’s Republic of ChinaInspection and Quarantine Branch, Guangzhou Customs Technical Center, Guangzhou, People’s Republic of ChinaImmunization Planning Unit, Henan Center for Disease Control and Prevention, Zhengzhou, People’s Republic of ChinaRegistry and Medical Center, Yunnan Walvax Biotechnology Co., Ltd., Kunming, People’s Republic of ChinaState Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, People’s Republic of ChinaRegistry and Medical Center, Yunnan Walvax Biotechnology Co., Ltd., Kunming, People’s Republic of ChinaRegistry and Medical Center, Yunnan Walvax Biotechnology Co., Ltd., Kunming, People’s Republic of ChinaClinical Research, First People’s Hospital, Shanghai, People’s Republic of ChinaImmunization Planning Unit, Yunnan Center for Disease Control and Prevention, Kunming, People’s Republic of ChinaDepartment of Statistics, Beijing Key Tech Statistical Consulting Co., Ltd., Beijing, People’s Republic of ChinaImmunization Planning Unit, Hunan Center for Disease Control and Prevention, Changsha, People’s Republic of ChinaRegistry and Medical Center, Yunnan Walvax Biotechnology Co., Ltd., Kunming, People’s Republic of ChinaImmunization Planning Unit, Hunan Center for Disease Control and Prevention, Changsha, People’s Republic of ChinaImmunization Planning Unit, Puer County Center for Disease Control and Prevention, Puer, People’s Republic of ChinaImmunization Planning Unit, Xiangyun County Center for Disease Control and Prevention, Dali, People’s Republic of ChinaImmunization Planning Unit, Luxi County Center for Disease Control and Prevention, Hmong Autonomous Region, People’s Republic of ChinaImmunization Planning Unit, Wuyang County Center for Disease Control and Prevention, Luohe, People’s Republic of ChinaRegistry and Medical Center, Yunnan Walvax Biotechnology Co., Ltd., Kunming, People’s Republic of ChinaResearch and Development Center, Shanghai RNACure Biopharma Co., Ltd., Shanghai, People’s Republic of ChinaImmunization Planning Unit, Wenxian County Center for Disease Control and Prevention, Jiaozuo, People’s Republic of ChinaImmunization Planning Unit, Huarong County Center for Disease Control and Prevention, Yueyang, People’s Republic of ChinaImmunization Planning Unit, Hengnan County Center for Disease Control and Prevention, Hengyang, People’s Republic of ChinaImmunization Planning Unit, Longyang County Center for Disease Control and Prevention, Baoshan, People’s Republic of ChinaImmunization Planning Unit, Yucheng County Center for Disease Control and Prevention, Shangqiu, People’s Republic of ChinaMahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandShanghai Institute of Infectious Disease and Biosecurity, Fudan University, Shanghai, People’s Republic of ChinaRegistry and Medical Center, Yunnan Walvax Biotechnology Co., Ltd., Kunming, People’s Republic of ChinaShanghai Institute of Infectious Disease and Biosecurity, Fudan University, Shanghai, People’s Republic of ChinaA 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.https://www.tandfonline.com/doi/10.1080/21645515.2025.2502250EfficacysafetymRNA vaccineCOVID-19chimeric |
| spellingShingle | Xiao-Qiang Liu Yang-Yang Qi Tao Huang Li-Li Huang Ming-Xuan Zhao Zhong-Fang Wang Jun Dai Yan-Xia Wang Jing-Jing Chen Xiao-Yun Yang Hui-Lan Fan Xue-Mei Yan Jian-Chang He Yan-Xiang Zou Zhi-Wei Jiang Zhi-Fei Zhan Si-Wen Tao De-Fang Dai Feng Shi Qiong-Na Zhang Xiu-Liang Yang Xiao-Zhong Li Wei Li Jing Lu Jiang-Bing Zheng Zhi-Hua Zhang Gao-Xiang Chen Hong Su Wei-Min Gao Lorenz von Seidlein Xuan-Yi Wang Lin Yuan Jin-Zhong Lin 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 & Immunotherapeutics Efficacy safety mRNA vaccine COVID-19 chimeric |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Efficacy safety mRNA vaccine COVID-19 chimeric |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2502250 |
| work_keys_str_mv | AT xiaoqiangliu efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT yangyangqi efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT taohuang efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT lilihuang efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT mingxuanzhao efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT zhongfangwang efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT jundai efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT yanxiawang efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT jingjingchen efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT xiaoyunyang efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT huilanfan efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT xuemeiyan efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT jianchanghe efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT yanxiangzou efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT zhiweijiang efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT zhifeizhan efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT siwentao efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT defangdai efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT fengshi efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT qiongnazhang efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT xiuliangyang efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT xiaozhongli efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT weili efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT jinglu efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT jiangbingzheng efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT zhihuazhang efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT gaoxiangchen efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT hongsu efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT weimingao efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT lorenzvonseidlein efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT xuanyiwang efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT linyuan efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial AT jinzhonglin efficacyimmunogenicityandsafetyofheterologousboostingwithanovelchimerachinesemrnarq3013sarscov2vaccinearandomizeddoubleblindactivecontrolledtrial |