Safety and Immunogenicity of Inactivated Poliovirus Vaccine Made From Sabin Strains: A Phase II, Randomized, Positive-Controlled Trial

• Published in: The Journal of infectious diseases Vol. 205; no. 2; pp. 237 - 243
• Main Authors: Liao, Guoyang, Li, Rongcheng, Li, Changgui, Sun, Mingbo, Li, Yanping, Chu, Jiayou, Jiang, Shude, Li, Qihan
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 15.01.2012
• Subjects: Antibodies; Antibodies, Viral - blood; Biological and medical sciences; Chi-Square Distribution; Confidence Intervals; Dosage; Female; Fundamental and applied biological sciences. Psychology; Humans; Immune response; Inactivated poliovirus vaccine; Infant; Infectious diseases; Lost to follow up; Male; Medical sciences; Microbiology; Miscellaneous; Oral poliovirus vaccine; Poliomyelitis; Poliomyelitis - immunology; Poliovirus; Poliovirus - immunology; Poliovirus Vaccine, Inactivated - administration & dosage; Poliovirus Vaccine, Inactivated - adverse effects; Poliovirus Vaccine, Inactivated - immunology; Poliovirus Vaccine, Oral - administration & dosage; Poliovirus Vaccine, Oral - adverse effects; Poliovirus Vaccine, Oral - immunology; Vaccination; Virology; Viruses; Virus; Infection; Immunogenicity; Picornaviridae; Vaccine strain; Phase II trial; Enterovirus; Poliovirus; Inactivated strain
• ISSN: 0022-1899; 1537-6613; 1537-6613
• DOI: 10.1093/infdis/jir723

Background. The production of Sabin inactivated polio virus vaccine (IPV) can reduce biosafety requirements in the posteradication/post-oral poliovirus vaccine (OPV) era. We conducted a phase II, randomized, positive-controlled trial to assess the safety and immunogenicity of Sabin IPV. Methods. The test groups (A, B, and C) received 3 doses of high, middle, and low D antigen (D Ag) of Sabin IPV at ages 2, 3, and 4 months, respectively. Infants in 2 control groups, group D and group E, received 3 doses of trivalent OPV and conventional IPV (cIPV), respectively, on the same schedule as that of groups A, B, and C. Serum samples were collected before and 30 days after the administration of the third dose. Results. In total, 500 infants were randomly assigned to 5 groups, and 449 infants completed the vaccine series. No serious adverse events were associated with vaccinations. After 3 doses, the seroconversion rates in groups A, B, C, D, and E were 100%, 97.8%, 96.6%, 100%, and 90.1%, respectively, for type 1 poliovirus; 97.7%, 95.7%, 78.7%, 100%, and 90.1%, respectively, for type 2; and 98.8%, 98.9%, 93.3%, 100%, and 97.8%, respectively, for type 3. Conclusions. Sabin IPV has good safety characteristics. The seroconversion rates for type 1 poliovirus (most appropriate concentration, 15 D Ag units [DU]), type 2 (32 DU), and type 3 (45 DU) Sabin IPV were similar to those of the OPV and cIPV control groups. Clinical Trials Registration. NCT01056705.