Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China

Shaohong Yan; Haiping Chen; Zhenguo Zhang; Shaoying Chang; Yanhui Xiao; Linyun Luo; Zhaoyong Zhang; Li Sun; Xiao Chen; Yunkai Yang; Xuanwen Shi; Yu Guo; Yunlong Sun; Hong Li; Na Li; Shasha Han; Meng Ma; Xiaoming Yang

doi:10.1016/j.vaccine.2020.07.042

Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China

Vaccine. 2020 Sep 11;38(40):6274-6279. doi: 10.1016/j.vaccine.2020.07.042. Epub 2020 Jul 31.

Authors

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

Affiliations

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.

PMID: 32747216
DOI: 10.1016/j.vaccine.2020.07.042

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.

Keywords: Bivalent oral poliovirus vaccine; Inactivated poliovirus vaccine; Poliovirus; Sabin strain.

Publication types

Clinical Trial, Phase IV
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Viral
Child, Preschool
China
Humans
Immunization Schedule
Infant
Poliomyelitis* / prevention & control
Poliovirus Vaccine, Inactivated / adverse effects
Poliovirus Vaccine, Oral / adverse effects
Poliovirus*
Vaccination

Substances

Antibodies, Viral
Poliovirus Vaccine, Inactivated
Poliovirus Vaccine, Oral

Associated data

ClinicalTrials.gov/NCT04054492