title: Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial.
abstract: The final endgame strategy of global polio eradication initiative includes switching from trivalent oral poliovirus vaccines (tOPV) to bivalent oral polio vaccine (bOPV), and introduction of inactivated poliovirus vaccine (IPV). This study compares IPV with tOPV week 39 boost in Indian infants.
  
  
  
  Starting 28 March 2012, we enrolled 372 Indian infant-mother pairs from Kolkata, India in an open-label, block-randomized, controlled trial comparing a 39 week tOPV to an IPV boost among infants immunized with three doses of tOPV. The primary outcome was mucosal immunity to poliovirus as measured by fecal polio virus shedding after OPV challenge. The secondary outcome was humoral response as defined by >1:8 titers for neutralizing antibodies at week 40. Seroconversion was measured by change in level of antibody titers from week 18 to week 40. The analyses were performed by both intention-to-treat (ITT) and per-protocol (PP) comparing the occurrences of outcomes between the arms of the study.
  
  
  
  Both the study arms provided equivalent mucosal immunity at 52 weeks with a total shedding prevalence of 28%. Vaccination with IPV resulted in significantly higher seroconversion rates for Polio type 2 (p = 0.03) and Polio type 3 (p < 0.01).
  
  
  
  This study indicates that an IPV boost at week 39 is equivalent to tOPV in intestinal immunity, and provides higher seroconversion compared to tOPV. The major limitation of the study was the additional OPV doses receive by infants during pulse polio immunization resulted in additional mucosal boosting, diminishing the impact of IPV or tOPV boost at week 39. However, IPV for OPV boost should prove to be a step forward in the global polio eradication initiative to reduce the problem of circulating vaccine-derived poliovirus (cVDPV).
authors.affiliation: National Institute of Cholera and Enteric Diseases, Kolkata, India.
authors.forename: Suman
authors.initials: S
authors.lastname: Kanungo
authors.affiliation: International Vaccine Institute, Seoul, South Korea.
authors.forename: Deok Ryun
authors.initials: DR
authors.lastname: Kim
authors.affiliation: National Institute of Cholera and Enteric Diseases, Kolkata, India.
authors.forename: Bisakha
authors.initials: B
authors.lastname: Haldar
authors.affiliation: Cone Health, Greensboro, NC, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Snider
authors.affiliation: Enterovirus Research Centre, Mumbai, India.
authors.forename: Uma
authors.initials: U
authors.lastname: Nalavade
authors.affiliation: International Vaccine Institute, Seoul, South Korea.
authors.forename: Soon Ae
authors.initials: SA
authors.lastname: Kim
authors.affiliation: International Vaccine Institute, Seoul, South Korea.
authors.forename: Ju Yeon
authors.initials: JY
authors.lastname: Park
authors.affiliation: National Institute of Cholera and Enteric Diseases, Kolkata, India.
authors.forename: Anuradha
authors.initials: A
authors.lastname: Sinha
authors.affiliation: National Institute of Cholera and Enteric Diseases, Kolkata, India.
authors.forename: Aiyel Haque
authors.initials: AH
authors.lastname: Mallick
authors.affiliation: National Institute of Cholera and Enteric Diseases, Kolkata, India.
authors.forename: Byomkesh
authors.initials: B
authors.lastname: Manna
authors.affiliation: National Institute of Cholera and Enteric Diseases, Kolkata, India.
authors.forename: Dipika
authors.initials: D
authors.lastname: Sur
authors.affiliation: National Institute of Cholera and Enteric Diseases, Kolkata, India.
authors.forename: Ranjan Kumar
authors.initials: RK
authors.lastname: Nandy
authors.affiliation: Enterovirus Research Centre, Mumbai, India.
authors.forename: Jagadish M
authors.initials: JM
authors.lastname: Deshpande
authors.affiliation: Institut de Pharmacologie Moleculaire & Cellulaire, CNRS-INSERM-University of Nice-Sophia Antipolis, Valbonne, France.
authors.forename: Cecil
authors.initials: C
authors.lastname: Czerkinsky
authors.affiliation: PATH, Washington, DC, USA.
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Wierzba
authors.affiliation: Division of Infectious Diseases and International Health, The University of Virginia, Charlottesville, VA, USA.
authors.forename: William A
authors.initials: WA
authors.lastname: Petri
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Ali
authors.affiliation: International Vaccine Institute, Seoul, South Korea.
authors.forename: Ayan
authors.initials: A
authors.lastname: Dey
keywords: Health profession; Immunology; Infectious disease; Internal medicine; Pathology; Pediatrics; Pharmaceutical science; Public health