title: Immunogenicity of supplemental doses of poliovirus vaccine for children aged 6-9 months in Moradabad, India: a community-based, randomised controlled trial.
abstract: BACKGROUND
  The continued presence of polio in northern India poses challenges to the interruption of wild poliovirus transmission and the management of poliovirus risks in the post-eradication era. We aimed to assess the current immunity profile after routine doses of trivalent oral poliovirus vaccine (OPV) and numerous supplemental doses of type-1 monovalent OPV (mOPV1), and compared the effect of five vaccine formulations and dosages on residual immunity gaps.
  
  
  METHODS
  We did a community-based, randomised controlled trial of healthy infants aged 6-9 months at ten sites in Moradabad, India. Serum neutralising antibody was measured before infants were randomly assigned to a study group and given standard-potency or higher-potency mOPV1, intradermal fractional-dose inactivated poliovirus vaccine (IPV, GlaxoSmithKline), or intramuscular full-dose IPV from two different manufacturers (GlaxoSmithKline or Panacea). Follow-up sera were taken at days 7 and 28. Our primary endpoint was an increase of more than four times in antibody titres. We did analyses by per-protocol in children with a blood sample available before, and 28 days after, receiving study vaccine (or who completed study procedures). This trial is registered with Current Controlled Trials, number ISRCTN90744784.
  
  
  RESULTS
  Of 1002 children enrolled, 869 (87%) completed study procedures (ie, blood sample available at day 0 and day 28). At baseline, 862 (99%), 625 (72%), and 418 (48%) had detectable antibodies to poliovirus types 1, 2, and 3, respectively. In children who were type-1 seropositive, an increase of more than four times in antibody titre was detected 28 days after they were given standard-potency mOPV1 (5/13 [38%]), higher-potency mOPV1 (6/21 [29%]), intradermal IPV (9/16 [56%]), GlaxoSmithKline intramuscular IPV (19/22 [86%]), and Panacea intramuscular IPV (11/13 [85%]). In those who were type-2 seronegative, 42 (100%) of 42 seroconverted after GlaxoSmithKline intramuscular IPV, and 24 (59%) of 41 after intradermal IPV (p<0·0001). 87 (90%) of 97 infants who were type-3 seronegative seroconverted after intramuscular IPV, and 21 (36%) of 49 after intradermal IPV (p<0·0001).
  
  
  CONCLUSIONS
  Supplemental mOPV1 resulted in almost total seroprevalence against poliovirus type 1, which is consistent with recent absence of poliomyelitis cases; whereas seroprevalence against types 2 and 3 was expected for routine vaccination histories. The immunogenicity of IPV produced in India (Panacea) was similar to that of an internationally manufactured IPV (GSK). Intradermal IPV was less immunogenic.
authors.affiliation: Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. cge3@cdc.gov
authors.forename: Concepción F
authors.initials: CF
authors.lastname: Estívariz
authors.forename: Hamid
authors.initials: H
authors.lastname: Jafari
authors.forename: Roland W
authors.initials: RW
authors.lastname: Sutter
authors.forename: T Jacob
authors.initials: TJ
authors.lastname: John
authors.forename: Vibhor
authors.initials: V
authors.lastname: Jain
authors.forename: Ashutosh
authors.initials: A
authors.lastname: Agarwal
authors.forename: Harish
authors.initials: H
authors.lastname: Verma
authors.forename: Mark A
authors.initials: MA
authors.lastname: Pallansch
authors.forename: Ajit P
authors.initials: AP
authors.lastname: Singh
authors.forename: Sherine
authors.initials: S
authors.lastname: Guirguis
authors.forename: Jitendra
authors.initials: J
authors.lastname: Awale
authors.forename: Anthony
authors.initials: A
authors.lastname: Burton
authors.forename: Sunil
authors.initials: S
authors.lastname: Bahl
authors.forename: Arani
authors.initials: A
authors.lastname: Chatterjee
authors.forename: R Bruce
authors.initials: RB
authors.lastname: Aylward
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D006801:Humans; D007194:India; D007223:Infant; D008297:Male; D009500:Neutralization Tests; D011051:Poliomyelitis / Q000276:immunology* / Q000517:prevention & control* / Q000821:virology; D017955:Poliovirus / Q000276:immunology*; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage* / Q000276:immunology*; D014611:Vaccination / Q000379:methods
chemical_list: D000914:Antibodies, Viral; D011055:Poliovirus Vaccine, Oral