tetano
Editor, Senior Moderator
Vaccine
. 2022 Jul 29;S0264-410X(22)00919-7.
doi: 10.1016/j.vaccine.2022.07.033. Online ahead of print.
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, open-label, randomised, controlled, phase 4 trial
Haiping Chen[SUP] 1 [/SUP], Zhuoying Huang[SUP] 2 [/SUP], Shaoying Chang[SUP] 3 [/SUP], Mei Hu[SUP] 4 [/SUP], Qingbin Lu[SUP] 5 [/SUP], Yuntao Zhang[SUP] 1 [/SUP], Hui Wang[SUP] 3 [/SUP], Yanhui Xiao[SUP] 1 [/SUP], Hui Wang[SUP] 6 [/SUP], Yonghong Ge[SUP] 7 [/SUP], Yong Zou[SUP] 8 [/SUP], Fuqiang Cui[SUP] 5 [/SUP], Shasha Han[SUP] 1 [/SUP], Min Zhang[SUP] 1 [/SUP], Shengyi Wang[SUP] 1 [/SUP], Xiaoping Zhu[SUP] 4 [/SUP], Biao Zhang[SUP] 9 [/SUP], Zhi Li[SUP] 2 [/SUP], Jia Ren[SUP] 2 [/SUP], Xiao Chen[SUP] 3 [/SUP], Rui Ma[SUP] 6 [/SUP], Lei Zhang[SUP] 7 [/SUP], Xue Guo[SUP] 8 [/SUP], Linyun Luo[SUP] 1 [/SUP], Xiaodong Sun[SUP] 10 [/SUP], Xiaoming Yang[SUP] 11 [/SUP]
Affiliations
Abstract
Background: The safety and immunogenicity of the coadministration of an inactivated SARS-CoV-2 vaccine (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 vaccine 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/PPV23 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 pneumoniae 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 satisfactory immunogenicity. This study is registered with ClinicalTrials.gov, NCT04790851.
Keywords: 23-valent pneumococcal polysaccharide vaccine; Coadministration; Inactivated SARS-CoV-2 vaccine; Split-virion inactivated influenza vaccine.
. 2022 Jul 29;S0264-410X(22)00919-7.
doi: 10.1016/j.vaccine.2022.07.033. Online ahead of print.
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, open-label, randomised, controlled, phase 4 trial
Haiping Chen[SUP] 1 [/SUP], Zhuoying Huang[SUP] 2 [/SUP], Shaoying Chang[SUP] 3 [/SUP], Mei Hu[SUP] 4 [/SUP], Qingbin Lu[SUP] 5 [/SUP], Yuntao Zhang[SUP] 1 [/SUP], Hui Wang[SUP] 3 [/SUP], Yanhui Xiao[SUP] 1 [/SUP], Hui Wang[SUP] 6 [/SUP], Yonghong Ge[SUP] 7 [/SUP], Yong Zou[SUP] 8 [/SUP], Fuqiang Cui[SUP] 5 [/SUP], Shasha Han[SUP] 1 [/SUP], Min Zhang[SUP] 1 [/SUP], Shengyi Wang[SUP] 1 [/SUP], Xiaoping Zhu[SUP] 4 [/SUP], Biao Zhang[SUP] 9 [/SUP], Zhi Li[SUP] 2 [/SUP], Jia Ren[SUP] 2 [/SUP], Xiao Chen[SUP] 3 [/SUP], Rui Ma[SUP] 6 [/SUP], Lei Zhang[SUP] 7 [/SUP], Xue Guo[SUP] 8 [/SUP], Linyun Luo[SUP] 1 [/SUP], Xiaodong Sun[SUP] 10 [/SUP], Xiaoming Yang[SUP] 11 [/SUP]
Affiliations
- PMID: 35931636
- PMCID: PMC9334936
- DOI: 10.1016/j.vaccine.2022.07.033
Abstract
Background: The safety and immunogenicity of the coadministration of an inactivated SARS-CoV-2 vaccine (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 vaccine 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/PPV23 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 pneumoniae 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 satisfactory immunogenicity. This study is registered with ClinicalTrials.gov, NCT04790851.
Keywords: 23-valent pneumococcal polysaccharide vaccine; Coadministration; Inactivated SARS-CoV-2 vaccine; Split-virion inactivated influenza vaccine.