title: Immunogenicity and safety evaluation of bivalent types 1 and 3 oral poliovirus vaccine by comparing different poliomyelitis vaccination schedules in China: A randomized controlled non-inferiority clinical trial.
abstract: The type 2 component of the oral poliovirus vaccine is targeted for global withdrawal through a switch from the trivalent oral poliovirus vaccine (tOPV) to a bivalent oral poliovirus vaccine (bOPV). The switch is intended to prevent paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess the immunogenicity and safety profile of 6 vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.
  
  
  
  A randomized controlled trial was conducted in China in 2015. Healthy newborn babies randomly received one of the following 6 vaccination schedules: cIPV-bOPV-bOPV(I-B-B), cIPV-tOPV-tOPV(I-T-T), cIPV-cIPV-bOPV(I-I-B), cIPV-cIPV-tOPV(I-I-T), cIPV-cIPV-cIPV(I-I-I), or tOPV-tOPV-tOPV(T-T-T). Doses were administered sequentially at 4-6 week intervals after collecting baseline blood samples. Patients were proactively followed up for observation of adverse events after the first dose and 30 days after all doses. The primary study objective was to investigate the immunogenicity and safety profile of different vaccine schedules, evaluated by seroconversion, seroprotection and antibody titer against poliovirus types 1, 2, and 3 in the per-protocol population.
  
  
  
  Of 600 newborn babies enrolled, 504 (84.0%) were included in the per-protocol population. For type 1 poliovirus, the differences in the seroconversion were 1.17% (95% CI = -2.74%, 5.08%) between I-B-B and I-T-T and 0.00% (95% CI: -6.99%, 6.99%) between I-I-B and I-I-T; for type 3 poliovirus, differences in the seroconversion were 3.49% (95% CI: -1.50%, 8.48%) between I-B-B and I-T-T and -2.32% (95% CI: -5.51%, 0.86%) between I-I-B and I-I-T. The non-inferiority conclusion was achieved in both poliovirus type 1 and 3 with the margin of -10%. Of 24 serious adverse events reported, no one was vaccine-related.
  
  
  
  The vaccination schedules with bOPV followed by one or 2 doses of IPV were recommended to substitute for vaccinations involving tOPV without compromising the immunogenicity and safety in the Chinese population. The findings will be essential for policy formulation by national and global authorities to facilitate polio elimination.
authors.affiliation: a Department of Health Statistics, School of Preventive Medicine , Fourth Military Medical University , Xi'an , Shaanxi , China.
authors.forename: Jingjun
authors.initials: J
authors.lastname: Qiu
authors.affiliation: b Beijing Tiantan Biological Products CO., Ltd. , Beijing , China.
authors.forename: Yunkai
authors.initials: Y
authors.lastname: Yang
authors.affiliation: c Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention , Nanning , Guangxi Zhuang Autonomous Region , China.
authors.forename: Lirong
authors.initials: L
authors.lastname: Huang
authors.affiliation: a Department of Health Statistics, School of Preventive Medicine , Fourth Military Medical University , Xi'an , Shaanxi , China.
authors.forename: Ling
authors.initials: L
authors.lastname: Wang
authors.affiliation: a Department of Health Statistics, School of Preventive Medicine , Fourth Military Medical University , Xi'an , Shaanxi , China.
authors.forename: Zhiwei
authors.initials: Z
authors.lastname: Jiang
authors.affiliation: c Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention , Nanning , Guangxi Zhuang Autonomous Region , China.
authors.forename: Jian
authors.initials: J
authors.lastname: Gong
authors.affiliation: b Beijing Tiantan Biological Products CO., Ltd. , Beijing , China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: b Beijing Tiantan Biological Products CO., Ltd. , Beijing , China.
authors.forename: Hongyan
authors.initials: H
authors.lastname: Wang
authors.affiliation: b Beijing Tiantan Biological Products CO., Ltd. , Beijing , China.
authors.forename: Shaohong
authors.initials: S
authors.lastname: Guo
authors.affiliation: a Department of Health Statistics, School of Preventive Medicine , Fourth Military Medical University , Xi'an , Shaanxi , China.
authors.forename: Chanjuan
authors.initials: C
authors.lastname: Li
authors.affiliation: b Beijing Tiantan Biological Products CO., Ltd. , Beijing , China.
authors.forename: Shuyuan
authors.initials: S
authors.lastname: Wei
authors.affiliation: c Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention , Nanning , Guangxi Zhuang Autonomous Region , China.
authors.forename: Zhaojun
authors.initials: Z
authors.lastname: Mo
authors.affiliation: a Department of Health Statistics, School of Preventive Medicine , Fourth Military Medical University , Xi'an , Shaanxi , China.
authors.forename: Jielai
authors.initials: J
authors.lastname: Xia
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D002681:China; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D011051:Poliomyelitis / Q000517:prevention & control*; D017955:Poliovirus / Q000276:immunology*; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D011055:Poliovirus Vaccine, Oral
keywords: immunization; inactivated polio vaccine; infectious disease; oral polio vaccine; polio; poliomyelitis; poliovirus; vaccine; vaccine schedule