title: Immunogenicity of Two Different Sequential Schedules of Inactivated Polio Vaccine Followed by Oral Polio Vaccine Versus Oral Polio Vaccine Alone in Healthy Infants in China.
abstract: BACKGROUND
  Two vaccination schedules where inactivated polio vaccine (IPV) was followed by oral polio vaccine (OPV) were compared to an OPV-only schedule.
  
  
  METHODS
  Healthy Chinese infants received a 3-dose primary series of IPV-OPV-OPV (Group A), IPV-IPV-OPV (Group B), or OPV-OPV-OPV (Group C) at 2, 3, and 4 months of age. At pre-Dose 1, 1-month, and 14-months post-Dose 3, polio 1, 2, and 3 antibody titers were assessed by virus-neutralizing antibody assay with Sabin or wild-type strains. Adverse events were monitored.
  
  
  RESULTS
  Anti-polio 1, 2, and 3 titers were ≥8 (1/dil) in >99% of participants, and Group A and Group B were noninferior to Group C at 1-month post-Dose 3 as assessed by Sabin strain-based assay (SSBA). In Group A 1-month post-Dose 3, there was no geometric mean antibody titers (GMT) differences for types 1 and 3; type 2 GMTs were ≈3-fold higher by wild-type strain-based assay (WTBA) versus SSBA. For Group B, GMTs were ≈1.7- and 3.6-fold higher for types 1 and 2 via WTBA, while type 3 GMTs were similar. For Group C, GMTs were ≈6.3- and 2-fold higher for types 1 and 3 with SSBA, and type 2 GMTs were similar. Antibodies persisted in >96.6% of participants. Adverse event incidence in each group was similar.
  
  
  CONCLUSIONS
  A primary series of 1 or 2 IPV doses followed by 2 or 1 OPV doses was immunogenic and noninferior to an OPV-only arm. SSBA was better at detecting antibodies elicited by OPV with antibody titers correlated to the number of OPV doses (NCT01475539).
authors.affiliation: Guangxi Center for Disease Prevention and Control, Nanning, China.
authors.forename: Rong-Cheng
authors.initials: RC
authors.lastname: Li
authors.affiliation: National Institutes for Food and Drug Control (NIFDC), Beijing, China.
authors.forename: Chang-Gui
authors.initials: CG
authors.lastname: Li
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Hai-Bo
authors.initials: HB
authors.lastname: Wang
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Hui-Min
authors.initials: HM
authors.lastname: Luo
authors.affiliation: Guangxi Center for Disease Prevention and Control, Nanning, China.
authors.forename: Yan-Ping
authors.initials: YP
authors.lastname: Li
authors.affiliation: National Institutes for Food and Drug Control (NIFDC), Beijing, China.
authors.forename: Jian-Feng
authors.initials: JF
authors.lastname: Wang
authors.affiliation: National Institutes for Food and Drug Control (NIFDC), Beijing, China.
authors.forename: Zhi-Fang
authors.initials: ZF
authors.lastname: Ying
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Wen-Zhou
authors.initials: WZ
authors.lastname: Yu
authors.affiliation: Sanofi Pasteur, Beijing, China.
authors.forename: Jean Denis
authors.initials: JD
authors.lastname: Shu
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Ning
authors.initials: N
authors.lastname: Wen
authors.affiliation: Sanofi Pasteur, Lyon, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Vidor
mesh_terms: D000914:Antibodies, Viral; D002681:China; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D011051:Poliomyelitis / Q000517:prevention & control*; D011054:Poliovirus Vaccine, Inactivated / Q000276:immunology*; D011055:Poliovirus Vaccine, Oral / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D011054:Poliovirus Vaccine, Inactivated; D011055:Poliovirus Vaccine, Oral
keywords: China; IPV; immunogenicity; sequential regimen