| Title | Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: A multicentre, non-inferiority, op |
| Authors | Chen, Haiping Huang, Zhuoying Chang, Shaoying Hu, Mei Lu, Qingbin Zhang, Yuntao Wang, Hui Xiao, Yanhui Ge, Yonghong Zou, Yong Cui, Fuqiang Han, Shasha Zhang, Min Wang, Shengyi Zhu, Xiaoping Zhang, Biao Li, Zhi Ren, Jia Chen, Xiao Ma, Rui Zhang, Lei Guo, Xue Luo, Linyun Sun, Xiaodong Yang, Xiaoming |
| Affiliation | China Natl Biotec Grp Co Ltd, 2 Shuangqiao St, Beijing 100024, Peoples R China Shanghai Municipal Ctr Dis Control & Prevent, 1380 Zhongshanxi St, Shanghai 200336, Peoples R China Shanxi Prov Ctr Dis Control & Prevent, Taiyuan, Peoples R China Sichuan Ctr Dis Control & Prevent, Chengdu, Peoples R China Peking Univ, Sch Publ Hlth, Dept Lab Sci & Technol, Beijing, Peoples R China Peking Univ, Vaccine Res Ctr, Sch Publ Hlth, Beijing, Peoples R China Beijing Inst Biol Prod Co Ltd, Beijing, Peoples R China Chengdu Inst Biol Prod Co Ltd, Chengdu, Peoples R China Changchun Inst Biol Prod Co Ltd, Changchun, Peoples R China Santai Cty Ctr Dis Control & Prevent, Mianyang, Peoples R China Wuhan Inst Biol Prod Co Ltd, Natl Engn Technol Res Ctr Combined Vaccines, Wuhan, Peoples R China |
| Keywords | SEASONAL INFLUENZA STREPTOCOCCUS-PNEUMONIAE HAEMOPHILUS-INFLUENZAE COVID-19 ADULTS POLICY COVERAGE DISEASE STATES |
| Issue Date | 26-Aug-2022 |
| Publisher | VACCINE |
| Abstract | Background: The safety and immunogenicity of the coadministration of an inactivated SARS-CoV-2 vac-cine (Sinopharm BBIBP-CorV), quadrivalent split-virion inactivated influenza vaccine (IIV4), and 23-valent pneumococcal polysaccharide vaccine (PPV23) in adults in China is unknown.Methods: In this open-label, non-inferiority, randomised controlled trial, participants aged >= 18 years were recruited from the community. Individuals were eligible if they had no history of SARS-CoV-2 vac-cine or any pneumonia vaccine and had not received an influenza vaccine during the 2020-21 influenza season. Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either: SARS-CoV-2 vaccine and IIV4 followed by SARS-CoV-2 vaccine and PPV23 (SARS-CoV-2 + IIV4/P PV23 group); two doses of SARS-CoV-2 vaccine (SARS-CoV-2 vaccine group); or IIV4 followed by PPV23 (IIV4/PPV23 group). Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28 before vaccination, and on day 56.Results: Between March 10 and March 15, 2021,1152 participants were recruited and randomly assigned to three groups (384 per group). 1132 participants were included in the per-protocol population (375 in the SARS-CoV-2 + IIV4/PPV23 group, 380 in the SARS-CoV-2 vaccine group, and 377 in the IIV4/PPV23 group). The seroconversion rate (100 % vs 100 %) and GMT (159.13 vs 173.20; GMT ratio of 0.92 [95 % CI 0.83 to 1.02]) of SARS-CoV-2 neutralising antibodies in the SARS-CoV-2 + IIV4/PPV23 group was not inferior to those in the SARS-CoV-2 vaccine group. The SARS-CoV-2 + IIV4/PPV23 group was not inferior to the IIV4/PPV23 group in terms of seroconversion rates and GMT of influenza virus antibodies for all strains except for the seroconversion rate for the B/Yamagata strain. The SARS-CoV-2 + IIV4/PPV23 group was not inferior to the IIV4/PPV23 group regarding seroconversion rates and GMC of Streptococcus pneu-moniae IgG antibodies specific to all serotypes. All vaccines were well tolerated. Conclusions: The coadministration of the inactivated SARS-CoV-2 vaccine and IIV4/PPV23 is safe with sat-isfactory immunogenicity.This study is registered with ClinicalTrials.gov, NCT04790851.(c) 2022 Elsevier Ltd. All rights reserved. |
| URI | http://hdl.handle.net/20.500.11897/655411 |
| ISSN | 0264-410X |
| DOI | 10.1016/j.vaccine.2022.07.033 |
| Indexed | SCI(E) |
| Appears in Collections: | 公共卫生学院 |
