title: Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, positive-controlled trial.
abstract: BACKGROUND
  The production of Sabin inactivated poliovirus 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.
  
  
  BACKGROUND
  NCT01056705.
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
authors.forename: Guoyang
authors.initials: G
authors.lastname: Liao
authors.forename: Rongcheng
authors.initials: R
authors.lastname: Li
authors.forename: Changgui
authors.initials: C
authors.lastname: Li
authors.forename: Mingbo
authors.initials: M
authors.lastname: Sun
authors.forename: Yanping
authors.initials: Y
authors.lastname: Li
authors.forename: Jiayou
authors.initials: J
authors.lastname: Chu
authors.forename: Shude
authors.initials: S
authors.lastname: Jiang
authors.forename: Qihan
authors.initials: Q
authors.lastname: Li
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D016009:Chi-Square Distribution; D016001:Confidence Intervals; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011051:Poliomyelitis / Q000276:immunology*; D017955:Poliovirus / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D011054:Poliovirus Vaccine, Inactivated; D011055:Poliovirus Vaccine, Oral