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Immunogenicity of full and fractional dose of inactivated poliovirus vaccine for use in routine immunization and outbreak response: an open-label, randomized controlled trial
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May 16 2019
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Source: Lancet. 393(10191):2624-2634
Details:
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Alternative Title:Lancet
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Personal Author:
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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
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Source:
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Pubmed ID:31104832
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Pubmed Central ID:PMC7069654
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Document Type:
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Funding:
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Volume:393
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Issue:10191
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[PDF-782.62 KB]
