Safety and immunogenicity of Ad5-nCoV immunization after three-dose priming with inactivated SARS-CoV-2 vaccine in Chinese adults

Hangjie Zhang, Nani Xu, Yu Xu, Pan Qin, Rongrong Dai, Bicheng Xu, Shenyu Wang, Linling Ding, Jian Fu, Shupeng Zhang, Qianhui Hua, Yuting Liao, Juan Yang, Xiaowei Hu, Jianmin Jiang and Huakun Lv ()
Additional contact information
Hangjie Zhang: Zhejiang Provincial Center for Disease Control and Prevention
Nani Xu: Xihu District Center for Disease Control and Prevention
Yu Xu: CanSino Biologics
Pan Qin: Xihu District Center for Disease Control and Prevention
Rongrong Dai: Hangzhou Medical College
Bicheng Xu: CanSino Biologics
Shenyu Wang: Zhejiang Provincial Center for Disease Control and Prevention
Linling Ding: Zhejiang Provincial Center for Disease Control and Prevention
Jian Fu: Zhejiang Provincial Center for Disease Control and Prevention
Shupeng Zhang: CanSino Biologics
Qianhui Hua: Ningbo University
Yuting Liao: Xiamen University
Juan Yang: Xiamen University
Xiaowei Hu: Xihu District Center for Disease Control and Prevention
Jianmin Jiang: Zhejiang Provincial Center for Disease Control and Prevention
Huakun Lv: Zhejiang Provincial Center for Disease Control and Prevention

Nature Communications, 2023, vol. 14, issue 1, 1-12

Abstract: Abstract Data on the safety and immunity of a heterologous booster (fourth dose) after three-doses of inactivated SARS-CoV-2 vaccine in Chinese adults are limited. We evaluate the safety and immunogenicity of Ad5-nCoV in a randomized, double-blind, parallel-controlled phase 4 clinical trial in Zhejiang, China (NCT05373030). Participants aged 18–80 years (100 per group), administered three doses of inactivated SARS-CoV-2 vaccine ≥6 months earlier, are enrolled and randomized 1:1 into two groups, which are administered intramuscular Ad5-nCoV or inactivated SARS-CoV-2 vaccine (CoronaVac or Covilo). All observed adverse reactions are predictable and manageable. Ad5-nCoV elicits significantly higher RBD-specific IgG levels, with a geometric mean concentration of 2924.0 on day 14 post-booster, 7.8-fold that of the inactivated vaccine. Pseudovirus-neutralizing antibodies to Omicron BA.4/5 show a similar pattern, with geometric mean titers of 228.9 in Ad5-nCoV group and 65.5 in inactivated vaccine group. Ad5-nCoV booster maintains high antibody levels on day 90, with seroconversion of 71.4%, while that of inactivated vaccine is 5.2%, almost pre-booster levels. A fourth Ad5-nCoV vaccination following three-doses of inactivated SARS-CoV-2 vaccine is immunogenic, tolerable, and more efficient than inactivated SARS-CoV-2 vaccine. Ad5-nCoV elicits a stronger humoral response against Omicron BA.4/5 and maintains antibody levels for longer than homologous boosting.

Date: 2023
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DOI: 10.1038/s41467-023-40489-2

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