Immunogenicity of full and fractional dose of inactivated poliovirus vaccine for use in routine immunization and outbreak response: an open-label, randomized controlled trial

Details

• Alternative Title:
  Lancet
• Personal Author:
  Snider, Cynthia J ; Zaman, Khalequ ; Estivariz, Concepcion F ; Yunus, Mohammad ; Weldon, William C ; Wannemuehler, Kathleen A ; Oberste, M Steven ; Pallansch, Mark A ; Wassilak, Steven GF ; Bari, Tajul Islam A ; Anand, Abhijeet
• Description:
  Background
  
  Intradermal administration of fractional inactivated poliovirus vaccine (fIPV) is a dose-sparing alternative to intramuscular full dose. We assessed the recommendation of two fIPV doses or one IPV dose for routine immunization, and a fIPV booster dose for outbreak response.
  
  Methods
  
  We conducted an open-label, randomized, controlled, inequality, non-inferiority trial in two Dhaka clinics, Bangladesh. Healthy infants were randomized at 6 weeks to one of four arms: (A) IPV at 14 weeks and IPV at 22 weeks (booster); (B) IPV at 14 weeks and fIPV booster; (C) IPV at 6 weeks and fIPV booster; or (D) fIPV at 6+14 weeks and fIPV booster. Vaccines were administered by needle-syringe, with intradermal adapter for fIPV. Vaccine response (seroconversion from seronegative (<1:8) at baseline to seropositive (≥1:8) or four-fold increase in reciprocal antibody titers adjusted for maternal antibody decay) to types 1, 2, and 3 at 22 weeks (routine immunization) and 26 weeks (outbreak response) was assessed in the intention-to-treat population. Non-inferiority margin was 12·5%. (Registered at ClinicalTrials.gov, number NCT02847026).
  
  Findings
  
  From September 1, 2016 to May 2, 2017, 1,076 participants were assigned to Arms A (n=271), B (n=267), C (n=268), and D (n=270). Vaccine response at 22 weeks to two doses of fIPV was significantly higher (p<0.0001) than one dose of IPV (Arm D versus A/B) for type 1 [212 (79%, 95%CI: 73%−83%) versus 305 (57%, 95%CI: 53%−61%)], type 2 [173 (64%, 95%CI: 58%−70%) versus 249 (46%, 95%CI: 42%−51%)], and type 3 [196 (73%, 95%CI: 67%−78%) versus 196 (36%, 95%CI: 33%−41%)]. At 26 weeks, fIPV booster was non-inferior to IPV (Arm B versus A) to types 1 (−1·1%, 90%CI: −2·2% - −0·1%), type 2 (0·4%, 90%CI: −2·2% - 1·4%), and type 3 (−1·5%, 90%CI: −3·2% - −0·2%). Of 129 adverse events, 21 were serious including one death; none were attributed to IPV/fIPV.
  
  Interpretation
  
  fIPV is an effective dose-sparing strategy for routine immunization and outbreak response.
  
  Funding
  
  U.S. Centers for Disease Control and Prevention
  
  
• Subjects:
  Antibodies, Viral Article Bangladesh Disease Outbreaks Female Fractional Inactivated Poliovirus Vaccine Humans Immunization, Secondary Immunogenicity Inactivated Poliovirus Vaccine Infant Injections, Intramuscular Male Poliomyelitis Poliovirus Poliovirus Vaccine, Inactivated

  More +
• Source:
  Lancet. 393(10191):2624-2634
• Pubmed ID:
  31104832
• Pubmed Central ID:
  PMC7069654
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHS/United States
• Volume:
  393
• Issue:
  10191
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:ea81c43d6fa2467f112fd735c9300349f9e5859f3b8803735e3104fbebc18b66
• Download URL:
  https://stacks.cdc.gov/view/cdc/85863/cdc_85863_DS1.pdf
• File Type:
  [PDF - 782.62 KB ]