Shaohong Yan1, Haiping Chen2, Zhenguo Zhang3, Shaoying Chang4, Yanhui Xiao2, Linyun Luo2, Zhaoyong Zhang1, Li Sun3, Xiao Chen4, Yunkai Yang5, Xuanwen Shi2, Yu Guo1, Yunlong Sun3, Hong Li4, Na Li5, Shasha Han2, Meng Ma5, Xiaoming Yang6. 1. Inner Mongolia Autonomous Region Disease Prevention and Control Center, Huhhot, China. 2. China National Biotec Group Company Limited, Beijing, China. 3. Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, China. 4. Shanxi Provincial Center for Disease Control and Prevention, Taiyuan, China. 5. Beijing Institute of Biological Products Company Limited, Beijing, China. 6. China National Biotec Group Company Limited, Beijing, China. Electronic address: yangxiaoming@sinopharm.com.
Abstract
BACKGROUND: The immunogenicity and safety of the sequential schedule of Sabin strain-based inactivated poliovirus vaccine (sIPV) and bivalent oral poliovirus vaccine (bOPV) remains poorly understood in Chinese population. METHODS: A multi-center, open-label, randomized controlled trial was performed involving 648 healthy infants aged 2 months from Inner Mongolia, Shanxi, and Hebei provinces. These participants were divided into three groups: sIPV-bOPV-bOPV, sIPV-sIPV-bOPV, and sIPV-sIPV-sIPV. Doses were administered sequentially at age 2, 3, and 4 months. Neutralisation assays were tested using sera collected at 2 months and 5 months. RESULTS:A total of 569 were included in the per-protocol analysis. The seroconversion rates of poliovirus type 1 and 3 were 100% in all three groups, the seroconversion rate of poliovirus type 2 was 91.53% (173/189) (95% CI: 86.62-95.08) in the sIPV-bOPV-bOPV group, 98.38% (182/185) (95% CI: 95.33-99.66) in the sIPV-sIPV-bOPV group, and 99.49% (194/195) (95% CI: 97.18-99.99) in the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus types 1 and 3, the sIPV-bOPV-bOPV and sIPV-sIPV-bOPV groups were non-inferior to the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus type 2, the sIPV-sIPV-bOPV group was non-inferior to the sIPV-sIPV-sIPV group, and the sIPV-bOPV-bOPV group was inferior to the sIPV-sIPV-sIPV group. All three groups exhibited good safety, with two serious adverse events reported, that were unrelated to vaccine. CONCLUSIONS: In china, a new vaccination schedule that including 2 doses of IPV in the national immunization programs is essential. Trial registration ClinicalTrials.govNCT04054492.
RCT Entities:
BACKGROUND: The immunogenicity and safety of the sequential schedule of Sabin strain-based inactivated poliovirus vaccine (sIPV) and bivalent oral poliovirus vaccine (bOPV) remains poorly understood in Chinese population. METHODS: A multi-center, open-label, randomized controlled trial was performed involving 648 healthy infants aged 2 months from Inner Mongolia, Shanxi, and Hebei provinces. These participants were divided into three groups: sIPV-bOPV-bOPV, sIPV-sIPV-bOPV, and sIPV-sIPV-sIPV. Doses were administered sequentially at age 2, 3, and 4 months. Neutralisation assays were tested using sera collected at 2 months and 5 months. RESULTS: A total of 569 were included in the per-protocol analysis. The seroconversion rates of poliovirus type 1 and 3 were 100% in all three groups, the seroconversion rate of poliovirus type 2 was 91.53% (173/189) (95% CI: 86.62-95.08) in the sIPV-bOPV-bOPV group, 98.38% (182/185) (95% CI: 95.33-99.66) in the sIPV-sIPV-bOPV group, and 99.49% (194/195) (95% CI: 97.18-99.99) in the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus types 1 and 3, the sIPV-bOPV-bOPV and sIPV-sIPV-bOPV groups were non-inferior to the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus type 2, the sIPV-sIPV-bOPV group was non-inferior to the sIPV-sIPV-sIPV group, and the sIPV-bOPV-bOPV group was inferior to the sIPV-sIPV-sIPV group. All three groups exhibited good safety, with two serious adverse events reported, that were unrelated to vaccine. CONCLUSIONS: In china, a new vaccination schedule that including 2 doses of IPV in the national immunization programs is essential. Trial registration ClinicalTrials.govNCT04054492.
Authors: Anna Lisa Ong-Lim; Georgi Shukarev; Mitzi Trinidad-Aseron; Delia Caparas-Yu; Astrid Greijer; Michel Duchene; Gert Scheper; Vitalija van Paassen; Mathieu Le Gars; Conor P Cahill; Hanneke Schuitemaker; Macaya Douoguih; Jeanne-Marie Jacquet Journal: Hum Vaccin Immunother Date: 2022-03-28 Impact factor: 4.526