title: Monovalent type 1 oral poliovirus vaccine among infants in India: report of two randomized double-blind controlled clinical trials.
abstract: BACKGROUND
  To provide the polio eradication initiative with more immunogenic oral poliovirus vaccines (OPVs), we evaluated newly developed monovalent type 1 OPV (mOPV1) among infants in India.
  
  
  METHODS
  Two double-blind randomized controlled clinical trials compared two mOPV1s (mOPV1 A and mOPV1 B) versus trivalent OPV (tOPV X) given at birth (trial I), or assessed two products of higher-potency mOPV1 (mOPV1 C and mOPV1 D) versus regular-potency mOPV1 (mOPV1 B) or tOPV Y given at birth and at 30 days (trial II).
  
  
  RESULTS
  In trial I, 597 newborns were enrolled, 66 withdrawn or excluded, leaving 531 (88.9%) subjects for analysis. Seroconversion to poliovirus type 1 was 10.4% for mOPV1 A, 15.6% for mOPV1 B and 10.2% for tOPV X. In trial II, 718 newborns were enrolled, 135 withdrawn or excluded, leaving 583 (81.2%) subjects for analysis. Seroconversion to poliovirus type 1 following a birth dose was 15.1%, 19.7%, 18.0% and 10.6%, following the 30-day dose 87.1%, 89.2%, 84.4%, or 55.9%, and cumulative for both doses 90.4%, 90.3%, 89.5% and 61.9% for mOPV1s B, C, and D and tOPV Y, respectively.
  
  
  CONCLUSIONS
  In both studies, seronconversion rates were unexpectedly low to poliovirus type 1 after mOPV1 or tOPV given at birth but high for all formulations of mOPV1 given at age 30 days. The cause for low immunogenicity of OPV at birth in India is not known.
authors.forename: T Jacob
authors.initials: TJ
authors.lastname: John
authors.forename: Hemant
authors.initials: H
authors.lastname: Jain
authors.forename: Kanithi
authors.initials: K
authors.lastname: Ravishankar
authors.forename: A
authors.initials: A
authors.lastname: Amaresh
authors.forename: Harish
authors.initials: H
authors.lastname: Verma
authors.forename: Jagadish
authors.initials: J
authors.lastname: Deshpande
authors.forename: Mark A
authors.initials: MA
authors.lastname: Pallansch
authors.forename: Ajit Pal
authors.initials: AP
authors.lastname: Singh
authors.forename: Meghana
authors.initials: M
authors.lastname: Sreevatsava
authors.forename: Anthony
authors.initials: A
authors.lastname: Burton
authors.forename: Pradeep
authors.initials: P
authors.lastname: Malankar
authors.forename: Arani
authors.initials: A
authors.lastname: Chatterjee
authors.forename: Roland W
authors.initials: RW
authors.lastname: Sutter
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D005260:Female; D006801:Humans; D017589:Immunization Programs; D007194:India; D007231:Infant, Newborn; D008297:Male; D011051:Poliomyelitis / Q000276:immunology / 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