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Hum Vaccin Immunother
. 2025 Dec;21(1):2502250.
doi: 10.1080/21645515.2025.2502250. Epub 2025 May 16. 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
Xiao-Qiang Liu 1 , Yang-Yang Qi 2 , Tao Huang 3 , Li-Li Huang 4 , Ming-Xuan Zhao 5 , Zhong-Fang Wang 6 , Jun Dai 7 , Yan-Xia Wang 4 , Jing-Jing Chen 8 , Xiao-Yun Yang 6 , Hui-Lan Fan 8 , Xue-Mei Yan 8 , Jian-Chang He 5 , Yan-Xiang Zou 1 , Zhi-Wei Jiang 9 , Zhi-Fei Zhan 3 , Si-Wen Tao 8 , De-Fang Dai 3 , Feng Shi 10 , Qiong-Na Zhang 11 , Xiu-Liang Yang 12 , Xiao-Zhong Li 13 , Wei Li 8 , Jing Lu 14 , Jiang-Bing Zheng 15 , Zhi-Hua Zhang 16 , Gao-Xiang Chen 17 , Hong Su 18 , Wei-Min Gao 19 , Lorenz von Seidlein 20 , Xuan-Yi Wang 2 21 22 , Lin Yuan 8 23 , Jin-Zhong Lin 2 24 25
Affiliations
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.
Keywords: COVID-19; Efficacy; chimeric; mRNA vaccine; safety.
. 2025 Dec;21(1):2502250.
doi: 10.1080/21645515.2025.2502250. Epub 2025 May 16. 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
Xiao-Qiang Liu 1 , Yang-Yang Qi 2 , Tao Huang 3 , Li-Li Huang 4 , Ming-Xuan Zhao 5 , Zhong-Fang Wang 6 , Jun Dai 7 , Yan-Xia Wang 4 , Jing-Jing Chen 8 , Xiao-Yun Yang 6 , Hui-Lan Fan 8 , Xue-Mei Yan 8 , Jian-Chang He 5 , Yan-Xiang Zou 1 , Zhi-Wei Jiang 9 , Zhi-Fei Zhan 3 , Si-Wen Tao 8 , De-Fang Dai 3 , Feng Shi 10 , Qiong-Na Zhang 11 , Xiu-Liang Yang 12 , Xiao-Zhong Li 13 , Wei Li 8 , Jing Lu 14 , Jiang-Bing Zheng 15 , Zhi-Hua Zhang 16 , Gao-Xiang Chen 17 , Hong Su 18 , Wei-Min Gao 19 , Lorenz von Seidlein 20 , Xuan-Yi Wang 2 21 22 , Lin Yuan 8 23 , Jin-Zhong Lin 2 24 25
Affiliations
- PMID: 40376714
- DOI: 10.1080/21645515.2025.2502250
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.
Keywords: COVID-19; Efficacy; chimeric; mRNA vaccine; safety.