title: Randomized trial of type 1 and type 3 oral monovalent poliovirus vaccines in newborns in Africa.
abstract: BACKGROUND
  The Global Polio Eradication Initiative aims to eradicate wild poliovirus by the end of 2012. Therefore, more-immunogenic polio vaccines, including monovalent oral poliovirus vaccines (mOPVs), are needed for supplemental immunization activities. This trial assessed the immunogenicity of monovalent types 1 and 3, compared with that of trivalent oral poliovirus vaccine (tOPV), in South Africa.
  
  
  METHODS
  We conducted a blinded, randomized, 4-arm controlled trial comparing the immunogenicity of a single dose of mOPV1 (from 2 manufacturers) and mOPV3 (from 1 manufacturer), given at birth, with the immunogenicity of tOPV.
  
  
  RESULTS
  Eight hundred newborns were enrolled; 762 (95%) were included in the analysis. At 30 days after vaccine administration, seroconversion to poliovirus type 1 was 73.4% and 76.4% in the 2 mOPV1 arms, compared with 39.1% in the tOPV arm (P < .0000001), and seroconversion to poliovirus type 3 was 58.0% in the mOPV3 arm, compared with 21.2% in the tOPV arm (P < .0000001). The vaccines were well tolerated, and no adverse events were attributed to trial interventions.
  
  
  CONCLUSIONS
  A dose of mOPV1 or mOPV3 at birth was superior to that of tOPV in inducing type-specific seroconversion in this sub-Saharan African population. Our results support continued use of mOPVs in supplemental immunization activities in countries where poliovirus types 1 or 3 circulate. Clinical Trials Registration. ISRCTN18107202.
authors.affiliation: School of Child and Adolescent Health and Institute of Infectious Disease and Molecular Medicine, Medicine, University of Cape Town, Cape Town, South Africa. zainab.waggie@uct.ac.za
authors.forename: Zainab
authors.initials: Z
authors.lastname: Waggie
authors.forename: Hennie
authors.initials: H
authors.lastname: Geldenhuys
authors.forename: Roland W
authors.initials: RW
authors.lastname: Sutter
authors.forename: Mariana
authors.initials: M
authors.lastname: Jacks
authors.forename: Humphrey
authors.initials: H
authors.lastname: Mulenga
authors.forename: Hassan
authors.initials: H
authors.lastname: Mahomed
authors.forename: Marwou
authors.initials: M
authors.lastname: De Kock
authors.forename: Willem
authors.initials: W
authors.lastname: Hanekom
authors.forename: Mark A
authors.initials: MA
authors.lastname: Pallansch
authors.forename: Anna-Lea
authors.initials: AL
authors.lastname: Kahn
authors.forename: Anthony H
authors.initials: AH
authors.lastname: Burton
authors.forename: Meghana
authors.initials: M
authors.lastname: Sreevatsava
authors.forename: Gregory
authors.initials: G
authors.lastname: Hussey
mesh_terms: D000349:Africa; D000914:Antibodies, Viral / Q000097:blood*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D011051:Poliomyelitis / Q000276:immunology*; D017955:Poliovirus / Q000276:immunology*; D011055:Poliovirus Vaccine, Oral / Q000009:adverse effects / Q000276:immunology*; D016037:Single-Blind Method; D013019:South Africa; D018709:Statistics, Nonparametric
chemical_list: D000914:Antibodies, Viral; D011055:Poliovirus Vaccine, Oral