Immunogenicity of two-dose and three-dose vaccination schedules with Sabin inactivated poliovirus vaccine in China: An open-label, randomized, controlled trial

The Lancet Regional Health. Western Pacific

Zhijie An¹  Ning Wen²  Zundong Yin²  Lance Rodewald²  Zijian Feng²  Yamin Wang²  Jie Wang³  Hui Yuan⁴  Changgui Li⁵  Zhifang Ying⁵  Ondrej Mach⁶  Vishali Jeyaseelan⁶  Roland Sutter⁶  Qing Xu⁷  Aiqiang Xu⁷ 

[1] Correspondence authors.;Chinese Center for Disease Control and Prevention, Beijing, China;Dezhou prefecture-level Center for Disease Control and Prevention, Dezhou, Shandong, China;Liaocheng prefecture-level Center for Disease Control and Prevention, Liaocheng, Shandong, China;National Institutes for Food and Drug Control, Beijing, China;Polio Eradication Department, World Health Organization, Geneva, Switzerland;Shandong Provincial Center for Disease Control and Prevention, Jinan, China;

关键词: Inactivated polio vaccine;    Seroprevalence;    Sabin Strain;   

DOI  :  

来源: DOAJ

【 摘 要 】

Background: We assessed immunogenicity of three-dose and two-dose immunization schedules with a Sabin-strain inactivated poliovirus vaccine (sIPV) produced by one Chinese vaccine manufacturer. Methods: This was an open label, randomized, controlled trial conducted in 16 vaccination clinics in Shandong province. Infants were allocated randomly to either a 3-dose study arm (sIPV administered at 2, 3, and 4 months of age) or a 2-dose arm (sIPV administered at 4 and 8–11 months of age). Poliovirus neutralizing antibodies were measured in sera collected prior to the first sIPV dose and one month after the last dose. Findings: We enrolled 560 infants; 536 (95.7%) completed the study. Final seropositivity rates were >98% for all three serotypes in both study arms. There were no statistically significant differences in seropositivity between the 2-dose and the 3-dose schedule. Final median reciprocal titres of polio antibodies were high overall (>1:768 for all serotypes) and statistically significantly higher in 2-dose recipients compared with 3-dose recipients (p < 0.001). Interpretation: This study offers evidence that two doses of sIPV administered at 4 and 8–11 months of age and three doses of sIPV administered at 2, 3, and 4 months of age both provide serological protection against poliomyelitis. Median reciprocal titres of polio antibodies were high overall, and were more related to the interval between doses than the number of doses, with the longer interval of the 2-dose schedule producing higher reciprocal titres than the shorter-interval 3-dose schedule. The protection provided by the 3-dose schedule is achieved earlier in life than the protection with the 2-dose schedule. Countries planning to use an IPV-only schedule in the post-eradication era can consider this 2-dose sIPV option as an immunogenic and dose-sparing strategy. Funding: World Health Organization (from a grant from International PolioPlus Committee, Rotary International, Evanston, IL, USA).

【 授权许可】

Unknown