Safety, immunogenicity, and immune persistence of two inactivated COVID-19 vaccines replacement vaccination in China: An observational cohort study

• Published in: Vaccine Vol. 40; no. 39; pp. 5701 - 5708
• Main Authors: Wang, Xiaoqi, Deng, Yao, Zhao, Li, Wang, Lei, Fu, Zhenwang, Tang, Lin, Ye, Fei, Liu, Qianqian, Wang, Wenling, Wang, Siquan, Hu, Bo, Guan, Xuhua, Han, Zhuling, Tong, Yeqing, Rodewald, Lance E., Yin, Zundong, Tan, Wenjie, Wang, Fuzhen, Huang, Baoying
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 16.09.2022; Elsevier Limited; The Authors. Published by Elsevier Ltd
• Subjects: Adolescent; Adult; adverse effects; Allergy and Immunology; Antibodies, Viral; Biological products; China; Clinical trials; Cohort analysis; Cohort Studies; Coronaviruses; COVID-19; COVID-19 - prevention & control; COVID-19 infection; COVID-19 vaccines; COVID-19 Vaccines - adverse effects; cytopathogenicity; Disease transmission; Epidemics; Humans; Immune persistence; Immunization; Immunogenicity; Immunogenicity, Vaccine; immunoglobulins; Inactivated vaccine; International standards; Medical laboratories; Middle Aged; Neutralization; Observational studies; Questionnaires; Regression analysis; Replacement vaccine; Safety; Sample size; SARS-CoV-2; seroprevalence; Severe acute respiratory syndrome coronavirus 2; Vaccination; Vaccines; Vaccines, Inactivated - adverse effects; Young Adult; Beijing China; China; COVID-19; Safety; Immune persistence; Immunogenicity; Replacement vaccine; Inactivated vaccine
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2022.08.037

To mitigate a national shortage of WIBP-CorV COVID-19 vaccine, China’s regulator approved administering BBIBP-CorV after WIBP-CorV for completion of a primary series. In a pragmatic observational study, we compared immunogenicity and safety of a primary series of WIBP-CorV followed by BBIBP-CorV with a primary series of two doses of BBIBP-CorV. We invited healthy 18–59-years-old adults who had already received either WIBP-CorV or BBIBP-CorV as their first dose in a primary series to participate in this observational cohort study. Subjects who had received WIBP-CorV as their first dose became the observation group; subjects who had received BBIBP-CorV as their first dose became the control group. All participants received BBIBP-CorV as their second dose. We obtained sera 1, 2, and 6 months after second doses for nAb titer measurement by micro-neutralization cytopathic effect assay with SARS-CoV-2 strain HB01, standardized with WHO International Standard for anti-SARS-CoV-2 immunoglobulin. Safety was assessed for the 7 days after administration of second doses. Between March and December 2021, 275 subjects were included in the observation group and 133 in the control group. Neutralizing seropositivity (≥1:4) rates were 98.91 % and 99.25 % at 1 month and 53.16 % and 70.69 % at 6 months. One-month geometric mean titers (GMTs) were 21.33 and 22.45; one-month geometric mean concentrations (GMCs) were 227.71 IU/mL and 273.27 IU/mL. One to two months after vaccination, observation group seropositivity rates and titers were not significantly different to the control group’s. Adverse reaction rates were 11.27 % and 18.80 %, all mild or moderate in severity. Both primary series were immunogenic; immunogenicity of WIBP-CorV followed by BBIBP-CorV was not different than immunogenicity following two doses of BBIBP-CorV for two months after vaccination; safety profiles were acceptable for both regimens. BBIBP-CorV can be used to complete a primary series that started with WIBP-CorV.