Mingbo Sun1, Changgui Li2, Wenbo Xu3, Guoyang Liao4, Rongcheng Li5, Jian Zhou6, Yanping Li5, Wei Cai6, Dongmei Yan3, Yanchun Che1, Zhifang Ying2, Jianfeng Wang2, Huijuan Yang6, Yan Ma6, Lei Ma4, Guang Ji6, Li Shi1, Shude Jiang1, Qihan Li1. 1. Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Disease, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan. 2. Third Division of Viral Vaccines, National Institutes for Food and Drug Control, and. 3. Ministry of Health Key Laboratory for Medical, Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing. 4. No. 5 Department of Biological Products, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan. 5. Vaccine Clinical Research Center, Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, and. 6. No. 4 Department of Biological Products, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan, China.
Abstract
BACKGROUND: A Sabin strain-based inactivated poliomyelitis vaccine (Sabin-IPV) is the rational option for completely eradicating poliovirus transmission. The neutralizing capacity of Sabin-IPV immune serum to different strains of poliovirus is a key indicator of the clinical protective efficacy of this vaccine. METHODS: Sera collected from 500 infants enrolled in a randomized, blinded, positive control, phase 2 clinical trial were randomly divided into 5 groups: Groups A, B, and C received high, medium, and low doses, respectively, of Sabin-IPV, while groups D and E received trivalent oral polio vaccine and Salk strain-based IPV, respectively, all on the same schedule. Immune sera were collected after the third dose of primary immunization, and tested in cross-neutralization assays against 19 poliovirus strains of all 3 types. RESULTS: All immune sera from all 5 groups interacted with the 19 poliovirus strains with various titers and in a dose-dependent manner. One type 2 immunodeficiency-associated vaccine-derived poliovirus strain was not recognized by these immune sera. CONCLUSIONS: Sabin-IPV vaccine can induce protective antibodies against currently circulating and reference wild poliovirus strains and most vaccine-derived poliovirus strains, with rare exceptions. CLINICAL TRIALS REGISTRATION: NCT01056705.
BACKGROUND: A Sabin strain-based inactivated poliomyelitis vaccine (Sabin-IPV) is the rational option for completely eradicating poliovirus transmission. The neutralizing capacity of Sabin-IPV immune serum to different strains of poliovirus is a key indicator of the clinical protective efficacy of this vaccine. METHODS: Sera collected from 500 infants enrolled in a randomized, blinded, positive control, phase 2 clinical trial were randomly divided into 5 groups: Groups A, B, and C received high, medium, and low doses, respectively, of Sabin-IPV, while groups D and E received trivalent oral polio vaccine and Salk strain-based IPV, respectively, all on the same schedule. Immune sera were collected after the third dose of primary immunization, and tested in cross-neutralization assays against 19 poliovirus strains of all 3 types. RESULTS: All immune sera from all 5 groups interacted with the 19 poliovirus strains with various titers and in a dose-dependent manner. One type 2 immunodeficiency-associated vaccine-derived poliovirus strain was not recognized by these immune sera. CONCLUSIONS: Sabin-IPV vaccine can induce protective antibodies against currently circulating and reference wild poliovirus strains and most vaccine-derived poliovirus strains, with rare exceptions. CLINICAL TRIALS REGISTRATION: NCT01056705.