title: Early priming with inactivated poliovirus vaccine (IPV) and intradermal fractional dose IPV administered by a microneedle device: A randomized controlled trial.
abstract: BACKGROUND
  Inactivated poliovirus vaccine (IPV) introduction and phased oral poliovirus vaccine (OPV) cessation are essential for eradication of polio.
  
  
  METHODS
  Healthy 6-week old infants in Bangladesh were randomized to one of five study arms: receipt of trivalent OPV (tOPV) or bivalent OPV (bOPV) at ages 6, 10 and 14 weeks, intramuscular IPV or intradermal one-fifth fractional dose IPV (f-IPV) at ages 6 and 14 weeks, or f-IPV at ages 6 and 14 weeks with bOPV at age 10 weeks (f-IPV/bOPV). All participants received tOPV at age 18 weeks.
  
  
  RESULTS
  Of 975 infants randomized, 95% (922) completed follow-up. Type 1 seroconversion after 3 doses at 6, 10 and 14 weeks was higher with bOPV compared with tOPV (99% vs 94%, p=0.019). Seroconversions to types 1 and 3 after 2 IPV doses at ages 6 and 14 weeks were no different than after 3 doses of tOPV or bOPV at ages 6, 10 and 14 weeks. A priming response, seroconversion 1 week after IPV at 14 weeks among those who did not seroconvert after IPV at 6 weeks, was observed against poliovirus types 1, 2 and 3 in 91%, 84% and 97%, respectively. Compared with IPV, f-IPV failed non-inferiority tests for seroconversion with 1 or 2 doses and priming after 1 dose.
  
  
  CONCLUSIONS
  The findings demonstrate considerable priming with IPV at age 6 weeks, comparable immunogenicity of tOPV and bOPV, and inferior immunogenicity of one-fifth f-IPV compared with IPV. If IPV induced priming at age 6 weeks is similar to that at age 14 weeks, IPV could be administered at a younger age and possibly with a higher coverage.
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30033, United States. Electronic address: aanand@cdc.gov.
authors.forename: Abhijeet
authors.initials: A
authors.lastname: Anand
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), 68 Shahid Tajuddin Sarani, Dhaka 1212, Bangladesh.
authors.forename: K
authors.initials: K
authors.lastname: Zaman
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30033, United States.
authors.forename: Concepción F
authors.initials: CF
authors.lastname: Estívariz
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), 68 Shahid Tajuddin Sarani, Dhaka 1212, Bangladesh.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Yunus
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30033, United States.
authors.forename: Howard E
authors.initials: HE
authors.lastname: Gary
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30033, United States.
authors.forename: William C
authors.initials: WC
authors.lastname: Weldon
authors.affiliation: Expanded Program on Immunization and Surveillance, Mohakhali, Dhaka 1212, Bangladesh.
authors.forename: Tajul I
authors.initials: TI
authors.lastname: Bari
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30033, United States.
authors.forename: M
authors.initials: M
authors.lastname: Steven Oberste
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30033, United States.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Wassilak
authors.affiliation: Stanford University, Stanford, CA 94305, United States.
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Luby
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30033, United States; International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), 68 Shahid Tajuddin Sarani, Dhaka 1212, Bangladesh.
authors.forename: James D
authors.initials: JD
authors.lastname: Heffelfinger
authors.affiliation: Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30033, United States.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Pallansch
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D001459:Bangladesh; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D007271:Injections, Intradermal / Q000295:instrumentation*; D008297:Male; D011051:Poliomyelitis / Q000517:prevention & control*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000276:immunology*; D016896:Treatment Outcome
chemical_list: D000914:Antibodies, Viral; D011054:Poliovirus Vaccine, Inactivated
keywords: Inactivated polio vaccine; Oral polio vaccine; Polio immunogenicity; Priming