Evaluating a multi-vaccine respiratory immunization strategy involving SARS-CoV-2, pneumococcal, and influenza vaccines in adults: A randomized, open-label, multicenter, controlled, non-inferiority Phase IV trial in China.
8 affiliations
- 1Medical Affairs Department, China National Biotec Group Company Limited, Beijing, China.
- 2Wuhan Institute of Biological Products Co., Ltd., Wuhan, China.
- 3National Engineering Technology Research Center for Combined Vaccines, Wuhan, China.
- 4Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.
- 5National Key Laboratory for Novel Vaccines Research and Development of Emerging Infectious Diseases, Wuhan, China.
- 6Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
- 7Medical Affairs Department, Changchun Institute of Biological Products Co., Ltd., Changchun, China.
- 8Medical Affairs Department, Chengdu Institute of Biological Products Co., Ltd., Chengdu, China.
Abstract
Co-administration of vaccines targeting multiple respiratory pathogens may enhance coverage and streamline adult immunization programs. We conducted a randomized, multicentre, open-label Phase IV trial registered at Chinese Clinical Trial Registry (ChiCTR2100046227) in China to evaluate the immunogenicity and safety of co-administering an inactivated SARS-CoV-2 vaccine (WIBP-CorV) with the 23-valent pneumococcal polysaccharide vaccine (PPV23) and a quadrivalent inactivated influenza vaccine (IIV4). A total of 1,404 adults aged ≥ 18 year, including equal numbers of adults aged 18-59 year and ≥60 year, were randomized 1:1:1 to receive WIBP-CorV + PPV23 on Day 0 followed by WIBP-CorV + IIV4 on Day 28, WIBP-CorV alone on Days 0 and 28, or PPV23 on Day 0 followed by IIV4 on Day 28. Co-administration preserved humoral immune responses across vaccine platforms. Non-inferiority in geometric mean titers or concentrations was demonstrated for SARS-CoV-2 neutralizing antibodies and pneumococcal serotype-specific IgG responses. Seroconversion rates were non-inferior to those following separate administration for all pneumococcal serotypes, though results were less consistent for SARS-CoV-2 (after the second dose) and influenza A(H1N1). Age-stratified analyses showed age- and strain-specific non-inferiority findings that should be interpreted cautiously. Co-administration demonstrated an acceptable safety profile, with only slightly higher rates of mild, transient local reactions and no vaccine-related serious adverse events (SAEs). These findings support the feasibility of co-administering WIBP-CorV with PPV23 and IIV4 while maintaining immunogenicity and safety in adults represented in this study.Trial registration The study was registered in the Chinese Clinical Trial Registry (ChiCTR) under registration number ChiCTR2100046227.
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BibTeX
@article{shi2026evaluating,
title = {{Evaluating a multi-vaccine respiratory immunization strategy involving SARS-CoV-2, pneumococcal, and influenza vaccines in adults: A randomized, open-label, multicenter, controlled, non-inferiority Phase IV trial in China.}},
author = {Xuanwen Shi and Shasha Han and Cong Wu and Xuejuan Wang and Jiao Huang and Wei Chen and Xiaoqin Liu and Sheng Wei and Jun Liu and Xiang Guo and Chenhao Wang and Shengyi Wang and Min Zhang and Xue Guo and Wei Zhao and Haiping Chen and Qingliang Li},
journal = {Human vaccines \& immunotherapeutics},
year = {2026},
month = oct,
doi = {10.1080/21645515.2026.2747495},
url = {https://europepmc.org/article/MED/42904667},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Evaluating a multi-vaccine respiratory immunization strategy involving SARS-CoV-2, pneumococcal, and influenza vaccines in adults: A randomized, open-label, multicenter, controlled, non-inferiority Phase IV trial in China.
AU - Xuanwen Shi
AU - Shasha Han
AU - Cong Wu
AU - Xuejuan Wang
AU - Jiao Huang
AU - Wei Chen
AU - Xiaoqin Liu
AU - Sheng Wei
AU - Jun Liu
AU - Xiang Guo
AU - Chenhao Wang
AU - Shengyi Wang
AU - Min Zhang
AU - Xue Guo
AU - Wei Zhao
AU - Haiping Chen
AU - Qingliang Li
PY - 2026
DA - 2026/10/21
JO - Human vaccines & immunotherapeutics
DO - 10.1080/21645515.2026.2747495
UR - https://europepmc.org/article/MED/42904667
AB - Co-administration of vaccines targeting multiple respiratory pathogens may enhance coverage and streamline adult immunization programs. We conducted a randomized, multicentre, open-label Phase IV trial registered at Chinese Clinical Trial Registry (ChiCTR2100046227) in China to evaluate the immunogenicity and safety of co-administering an inactivated SARS-CoV-2 vaccine (WIBP-CorV) with the 23-valent pneumococcal polysaccharide vaccine (PPV23) and a quadrivalent inactivated influenza vaccine (IIV4). A total of 1,404 adults aged ≥ 18 year, including equal numbers of adults aged 18-59 year and ≥60 year, were randomized 1:1:1 to receive WIBP-CorV + PPV23 on Day 0 followed by WIBP-CorV + IIV4 on Day 28, WIBP-CorV alone on Days 0 and 28, or PPV23 on Day 0 followed by IIV4 on Day 28. Co-administration preserved humoral immune responses across vaccine platforms. Non-inferiority in geometric mean titers or concentrations was demonstrated for SARS-CoV-2 neutralizing antibodies and pneumococcal serotype-specific IgG responses. Seroconversion rates were non-inferior to those following separate administration for all pneumococcal serotypes, though results were less consistent for SARS-CoV-2 (after the second dose) and influenza A(H1N1). Age-stratified analyses showed age- and strain-specific non-inferiority findings that should be interpreted cautiously. Co-administration demonstrated an acceptable safety profile, with only slightly higher rates of mild, transient local reactions and no vaccine-related serious adverse events (SAEs). These findings support the feasibility of co-administering WIBP-CorV with PPV23 and IIV4 while maintaining immunogenicity and safety in adults represented in this study.Trial registration The study was registered in the Chinese Clinical Trial Registry (ChiCTR) under registration number ChiCTR2100046227.
SN - 2164-5515
SN - 2164-554X
ER -