title: The Duration of Intestinal Immunity After an Inactivated Poliovirus Vaccine Booster Dose in Children Immunized With Oral Vaccine: A Randomized Controlled Trial.
abstract: In 2014, 2 studies showed that inactivated poliovirus vaccine (IPV) boosts intestinal immunity in children previously immunized with oral poliovirus vaccine (OPV). As a result, IPV was introduced in mass campaigns to help achieve polio eradication.
  
  
  
  We conducted an open-label, randomized, controlled trial to assess the duration of the boost in intestinal immunity following a dose of IPV given to OPV-immunized children. Nine hundred healthy children in Vellore, India, aged 1-4 years were randomized (1:1:1) to receive IPV at 5 months (arm A), at enrollment (arm B), or no vaccine (arm C). The primary outcome was poliovirus shedding in stool 7 days after bivalent OPV challenge at 11 months.
  
  
  
  For children in arms A, B, and C, 284 (94.7%), 297 (99.0%), and 296 (98.7%), respectively, were eligible for primary per-protocol analysis. Poliovirus shedding 7 days after challenge was less prevalent in arms A and B compared with C (24.6%, 25.6%, and 36.4%, respectively; risk ratio 0.68 [95% confidence interval: 0.53-0.87] for A versus C, and 0.70 [0.55-0.90] for B versus C).
  
  
  
  Protection against poliovirus remained elevated 6 and 11 months after an IPV boost, although at a lower level than reported at 1 month.
  
  
  
  CTRI/2014/09/004979.
authors.affiliation: Department of Community Health, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Jacob
authors.initials: J
authors.lastname: John
authors.affiliation: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Sidhartha
authors.initials: S
authors.lastname: Giri
authors.affiliation: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Arun S
authors.initials: AS
authors.lastname: Karthikeyan
authors.affiliation: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Dipti
authors.initials: D
authors.lastname: Lata
authors.affiliation: Department of Community Health, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Shalini
authors.initials: S
authors.lastname: Jeyapaul
authors.affiliation: Department of Clinical Virology, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Anand K
authors.initials: AK
authors.lastname: Rajan
authors.affiliation: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Nirmal
authors.initials: N
authors.lastname: Kumar
authors.affiliation: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Pavithra
authors.initials: P
authors.lastname: Dhanapal
authors.affiliation: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Jayalakshmi
authors.initials: J
authors.lastname: Venkatesan
authors.affiliation: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Mohanraj
authors.initials: M
authors.lastname: Mani
authors.affiliation: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Janardhanan
authors.initials: J
authors.lastname: Hanusha
authors.affiliation: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Uma
authors.initials: U
authors.lastname: Raman
authors.affiliation: Department of Clinical Virology, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Prabhakar D
authors.initials: PD
authors.lastname: Moses
authors.affiliation: Department of Clinical Virology, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Asha
authors.initials: A
authors.lastname: Abraham
authors.affiliation: WHO Regional Office for South-East Asia, New Delhi, India.
authors.forename: Sunil
authors.initials: S
authors.lastname: Bahl
authors.affiliation: Bill & Melinda Gates Foundation, Seattle, Washington, USA.
authors.forename: Ananda S
authors.initials: AS
authors.lastname: Bandyopadhyay
authors.affiliation: WHO Country Office, New Delhi, India.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Ahmad
authors.affiliation: Department of Infectious Disease Epidemiology, Imperial College London, UK.
authors.forename: Nicholas C
authors.initials: NC
authors.lastname: Grassly
authors.affiliation: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Gagandeep
authors.initials: G
authors.lastname: Kang
mesh_terms: D057134:Antibodies, Neutralizing / Q000097:blood / Q000276:immunology; D000914:Antibodies, Viral / Q000097:blood / Q000276:immunology; D002675:Child, Preschool; D004306:Dose-Response Relationship, Immunologic; D005243:Feces / Q000821:virology; D005260:Female; D006801:Humans; D018928:Immunity, Mucosal; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007194:India; D007223:Infant; D007422:Intestines / Q000821:virology; D008297:Male; D011051:Poliomyelitis / Q000517:prevention & control*; D017955:Poliovirus; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000627:therapeutic use*; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods; D017201:Virus Shedding
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011054:Poliovirus Vaccine, Inactivated; D011055:Poliovirus Vaccine, Oral
keywords: human challenge; inactivated vaccine; oral vaccine; poliovirus; mucosal immunity