Phase 3 Trial of a Sabin Strain-Based Inactivated Poliovirus Vaccine.

Abstract

BACKGROUND:

 The development of a Sabin strain-based inactivated poliovirus vaccine (Sabin-IPV) is imperative to protecting against vaccine-associated paralytic poliomyelitis in developing countries.

METHODS:

 In this double-blinded, parallel-group, noninferiority trial, eligible infants aged 60-90 days were randomly assigned in a ratio of 1:1 to receive either 3 doses of Sabin-IPV or Salk strain-based IPV (Salk-IPV) at 30-day intervals and a booster at the age of 18 months. Immunogenicity and safety were assessed on the basis of a protocol.

RESULTS:

 Of 1438 infants, 1200 eligible infants were recruited and received either Sabin-IPV or Salk-IPV. From the Sabin-IPV and Salk-IPV groups, 570 and 564 infants, respectively, completed the primary immunization and formed the per-protocol population. The seroconversion rates of the participants who received Sabin-IPV were 100%, 94.9%, and 99.0% (types I, II, and III, respectively), and those of the participants who received Salk-IPV were 94.7%, 91.3%, and 97.9% 1 month after the completion of primary immunization. An anamnestic response for poliovirus types I, II, and III was elicited by a booster in both groups. Except in the case of fever, other adverse events were similar between the 2 groups.

CONCLUSIONS:

 The immune response induced by Sabin-IPV was not inferior to that established with Salk-IPV.

• Authors: Guoyang Liao, Rongcheng Li, Changgui Li, Mingbo Sun, Shude Jiang, Yanping Li, Zhaojun Mo, Jielai Xia, Zhongping Xie, Yanchun Che, Jingsi Yang, Zhifang Yin, Jianfeng Wang, Jiayou Chu, Wei Cai, Jian Zhou, Junzhi Wang, Qihan Li
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 214 Issue 11 Pg. 1728-1734 (Dec 01 2016) ISSN: 1537-6613 [Electronic] United States
• PMID: 27658691 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail [email protected].

Chemical References

• Antibodies, Viral
• Poliovirus Vaccine, Inactivated

Topics

• Antibodies, Viral (blood)
• Double-Blind Method
• Female
• Humans
• Immunization Schedule
• Infant
• Male
• Poliomyelitis (prevention & control)
• Poliovirus Vaccine, Inactivated (administration & dosage, adverse effects, immunology)