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

• Published in: Vaccine Vol. 38; no. 40; pp. 6274 - 6279
• Main Authors: Yan, Shaohong, Chen, Haiping, Zhang, Zhenguo, Chang, Shaoying, Xiao, Yanhui, Luo, Linyun, Zhang, Zhaoyong, Sun, Li, Chen, Xiao, Yang, Yunkai, Shi, Xuanwen, Guo, Yu, Sun, Yunlong, Li, Hong, Li, Na, Han, Shasha, Ma, Meng, Yang, Xiaoming
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 11.09.2020; Elsevier Limited
• Subjects: Age; Antibodies; Antibodies, Viral; Babies; Bivalent oral poliovirus vaccine; Child, Preschool; China; Clinical trials; Disease control; Disease prevention; Guardians; Humans; Immunization; Immunization Schedule; Immunogenicity; Immunology; Inactivated poliovirus vaccine; Infant; Infants; Laboratories; Poliomyelitis; Poliomyelitis - prevention & control; Poliovirus; Poliovirus Vaccine, Inactivated - adverse effects; Poliovirus Vaccine, Oral - adverse effects; Randomization; Research centers; Sabin strain; Safety; Schedules; Seroconversion; Vaccination; Vaccines; Viruses; China; Beijing China; Inner Mongolia China; Sabin strain; Inactivated poliovirus vaccine; Bivalent oral poliovirus vaccine; Poliovirus
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2020.07.042

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. 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. 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. In china, a new vaccination schedule that including 2 doses of IPV in the national immunization programs is essential. Trial registration ClinicalTrials.govNCT04054492.