The Immunogenicity of Fractional Intradermal Doses of the Inactivated Poliovirus Vaccine Is Associated With the Size of the Intradermal Fluid Bleb

Bibby, Jack; Saidu, Yauba; Umesi, Ama; Moneke-Anyanwoke, Ngozi; Bashorun, Adedapo Olufemi; Hydara, Mariama Badjie; Adigweme, Ikechukwu; Adetifa, Jane U.; Okoye, Michael; Roberts, Elishia; Clemens, Ralf; Bandyopadhyay, Ananda S; Muhammad, Abdul Khalie; Mulwa, Sarah; Royals, Michael; Jarrahian, Courtney; Jeffries, David; Kampmann, Beate; Clarke, Ed

doi:10.1093/cid/cix381

Cited by 5 publications

(3 citation statements)

References 3 publications

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“…During the campaign, data on the size of the intradermal fluid bleb, fluid loss onto the skin, time taken to administer each vaccine, and the amount of distress apparent in the child were collected, as previously described. 20 , 21 The number of fIPV doses obtained from each vial according to administration method was calculated to assess vaccine waste.…”

Section: Methodsmentioning

confidence: 99%

Intradermal administration of fractional doses of the inactivated poliovirus vaccine in a campaign: a pragmatic, open-label, non-inferiority trial in The Gambia

Bashorun¹,

Hydara²,

Adigweme³

et al. 2022

The Lancet Global Health

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Background A rapid increase in circulating vaccine-derived poliovirus type 2 outbreaks, and the need to reserve inactivated poliovirus vaccine (IPV) for routine immunisation, has increased the value of fractional dose IPV (fIPV) as a measure to prevent acute flaccid paralysis. However, the intradermal route of administration has been viewed as prohibitive to outbreak response campaigns. We aimed to establish the immunogenicity and safety of administering intradermal fIPV with a disposable syringe jet injector (DSJI) or an intradermal adaptor (IDA) compared with standard administration with a BCG needle and syringe (N&S). MethodsThis pragmatic, non-inferiority trial was undertaken in a campaign setting in communities in The Gambia. Children aged 4-59 months without contraindication to vaccination were eligible. Children were not individually randomly assigned; instead, the vaccination teams were randomly assigned (1:1:1) to one of three administration methods. Parents and the field team were not masked, but laboratory personnel were masked. Baseline demographic and anthropometric data were collected from the participants. Public health officers experienced at intradermal immunisation, and nurses without experience, had 2 h of training on each of the administration methods before the campaign. Participants were vaccinated using the administration method in use by the vaccination team in their community. Poliovirus serum neutralising antibodies (SNA) were measured in children aged 24-59 months before and 4 weeks after vaccination. Adverse events and data on injection quality were collected from all participants. The primary outcome was the type 2 immune response rate (seroconversion in seronegative [SNA titre <8] children plus a 4-fold titre rise in seropositive children). Adjusted differences in the immune response between the DSJI or IDA group versus the N&S group were calculated with 97•5% CIs. A margin of -10% was used to define the non-inferiority of DSJI or IDA compared to N&S. Immunogenicity analysis was done per protocol. The trial is registered with ClinicalTrials.gov NCT02967783 and has been completed. Findings Between Oct 28 and Dec 29, 2016, 3189 children aged 4-59 months were recruited, of whom 3170 were eligible. Over 3 days, 2720 children were vaccinated (N&S, 917; IDA, 874; and DSJI, 929). Among 992 children aged 25-59 months with a baseline SNA available, 90•1% (95% CI 86•1-92•9; 281/312) of those vaccinated using the DSJI had an immune response to type 2 compared with 93•8% (90•6-95•8; 331/353) of those vaccinated with N&S and 96•6% (94•0-98•0; 316/327) of those vaccinated with IDA. All (53/53) type 2 seronegative children seroconverted. For polio type 2, non-inferiority was shown for both the IDA (adjusted difference 0•7% [97•5% CI -3•3 to 4•7], unadjusted difference 2•9% [-0•9 to 6•8]) and DSJI (adjusted difference -3•3% [-8•3 to 1•5], unadjusted difference -3•7% [-8•7 to 1•1]) compared with N&S. Non-inferiority was shown for type 1 and 3 for the IDA and DSJI. Neither injection quality nor the tr...

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Section: Methodsmentioning

confidence: 99%

Intradermal administration of fractional doses of the inactivated poliovirus vaccine in a campaign: a pragmatic, open-label, non-inferiority trial in The Gambia

Bashorun¹,

Hydara²,

Adigweme³

et al. 2022

The Lancet Global Health

Self Cite

View full text Add to dashboard Cite

show abstract

“…Two fractional IPV doses administered at 3.5–4 months and at 8–9 months of age may induce greater than 95% seroconversion to the three serotypes [ 37 ]. The quality of the intradermal injection, which depends on the vaccinator technique and device used for injection, may also affect the immunogenicity of fractional IPV [ 40 ]. Loss of vaccine fluid on the skin and a small bleb size (below 5 mm) have been associated with inferior immune responses [ 40 ].…”

Section: Immunogenicity Of Ipv Opv or Opv + Ipv Combinationsmentioning

confidence: 99%

“…The quality of the intradermal injection, which depends on the vaccinator technique and device used for injection, may also affect the immunogenicity of fractional IPV [ 40 ]. Loss of vaccine fluid on the skin and a small bleb size (below 5 mm) have been associated with inferior immune responses [ 40 ].…”

Section: Immunogenicity Of Ipv Opv or Opv + Ipv Combinationsmentioning

confidence: 99%