Quantitative Analysis of the Instant and Persistent Inhibition Effects of Maternal Poliovirus Antibodies on the Immune Response in a Phase IV Trial of a Sabin Strain-Based Inactivated Poliovirus Vaccine
Qiongzhou Yin,
Yan Zheng,
Zhifang Ying,
Jingyu Li,
Ya Jiang,
Wenmei Bao,
Youjian Dou,
Yi Pu,
Jin Lei,
Haitao Yang,
Ruiju Jiang,
Yan Deng,
Zhimei Zhao,
Jing Pu,
Jing Yang,
Yadong Li,
Min Xu,
Wei Cai,
Yanchun Che,
Li Shi
Affiliations
Qiongzhou Yin
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Yan Zheng
Vaccine Clinical Research Center, Yunnan Center for Disease Control and Prevention, Kunming 650022, China
Zhifang Ying
Division of Respiratory Virus Vaccines, National Institutes for Food and Drug Control, Beijing 100050, China
Jingyu Li
Vaccine Clinical Research Center, Yunnan Center for Disease Control and Prevention, Kunming 650022, China
Ya Jiang
Mile Center for Disease Control and Prevention, Mile 652399, China
Wenmei Bao
Gejiu Center for Disease Control and Prevention, Gejiu 661000, China
Youjian Dou
Mile Center for Disease Control and Prevention, Mile 652399, China
Yi Pu
Gejiu Center for Disease Control and Prevention, Gejiu 661000, China
Jin Lei
Gejiu Center for Disease Control and Prevention, Gejiu 661000, China
Haitao Yang
Vaccine Clinical Research Center, Yunnan Center for Disease Control and Prevention, Kunming 650022, China
Ruiju Jiang
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Yan Deng
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Zhimei Zhao
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Jing Pu
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Jing Yang
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Yadong Li
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Min Xu
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Wei Cai
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Yanchun Che
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Li Shi
Institute of Medical Biology, Chinese Academy of Medical Science & Peking Union Medical College, Kunming 650118, China
Background: An inactivated poliomyelitis vaccine made from Sabin strains (sIPVs) has widely been used in China since 2015. However, the quantitative data on the instant and persistent inhibition effects of maternal poliovirus antibodies on the immune response to sIPV priming and booster vaccination have not been available yet. Objective: In this study, we aim to explore and quantify the instant and persistent inhibition effect of maternal poliovirus antibodies on the immune response elicited by sIPV primary and booster vaccination. Methods: The immunogenicity data consisting of the days 0 and 30 after the prime and booster vaccination of the sIPV in a phase IV trial were pooled for a quantitative analysis of the inhibition effect of maternal poliovirus antibody. The geometric mean ratio (GMR) was calculated using linear regression models, representing that every 2-fold higher maternal poliovirus antibody titer may result in a (1-GMR) lower postimmunization antibody titer. Results: The GMRs for poliovirus types 1, 2, and 3 were 0.79 (0.77–0.82), 0.85 (0.81–0.89), and 0.87 (0.83–0.91) at 30 days after the priming series, 0.86 (0.83–0.89), 0.81 (0.76–0.85), and 0.86 (0.80–0.93) at one year after the priming series, and 0.96 (0.94–0.99), 0.89 (0.86–0.93), and 0.98 (0.93–1.03) at 30 days after the booster dose. The inhibition effect continued to exist until the booster dose 1 year later, and such a persistent inhibition effect was almost attenuated for poliovirus types 1 and 3, and partly reduced for type 2 at 30 days after the booster dose. Conclusion: A wider interval between the four sIPV doses might be a consideration for reducing the effect of maternal antibodies and subsequently eliciting and maintaining higher antibody levels to protect against poliovirus transmission and infection at the final stage of polio eradication in the global world. This study’s clinical trial registry number is NCT04224519.
