Needle-free injectors for mass administration of fractional dose inactivated poliovirus vaccine in Karachi, Pakistan: A survey of caregiver and vaccinator acceptability

Daly, Catherine; Molodecky, Natalia A.; Sreevatsava, Meghana; Belayneh, Asalif; Chandio, Shoukat Ali; Partridge, Jeff; Shaikh, Ahmed; Laghari, Mumtaz Ali; Agbor, John; Safdar, Rana Muhammad; Bullo, Umar Farooq; Malik, Safi M.; Mahamud, Abdirahman

doi:10.1016/j.vaccine.2019.12.059

Cited by 24 publications

(16 citation statements)

References 10 publications

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“…Both devices also show high acceptability among vaccinators, study subjects, and caregivers. For example, in an effort involving polio vaccination, acceptability survey data for Tropis indicated that 4638/4813 (94.7%) caregivers said they would be more likely to bring their child for vaccination in a future campaign that used jet injectors versus needle and syringe 22 . In a clinical study, the immunogenicity of an inactivated influenza vaccine delivered with the PharmaJet Stratis elicited antibody titers that were comparable to those measured following traditional needle and syringe delivery 23 .…”

Section: Introductionmentioning

confidence: 99%

A DNA vaccine targeting VEE virus delivered by needle-free jet-injection protects macaques against aerosol challenge

et al. 2022

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We have previously shown that DNA vaccines expressing codon optimized alphavirus envelope glycoprotein genes protect both mice and nonhuman primates from viral challenge when delivered by particle-mediated epidermal delivery (PMED) or intramuscular (IM) electroporation (EP). Another technology with fewer logistical drawbacks is disposable syringe jet injection (DSJI) devices developed by PharmaJet, Inc. These needle-free jet injection systems are spring-powered and capable of delivering vaccines either IM or into the dermis (ID). Here, we evaluated the immunogenicity of our Venezuelan equine encephalitis virus (VEEV) DNA vaccine delivered by either the IM- or ID-DSJI devices in nonhuman primates. The protective efficacy was assessed following aerosol challenge. We found that a prime and single boost by either the IM or ID route resulted in humoral and cellular immune responses that provided significant protection against disease and viremia. Although the ID route utilized one-fifth the DNA dose used in the IM route of vaccination, and the measured humoral and cellular immune responses trended lower, the level of protection was high and performed as well as the IM route for several clinical endpoints.

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Section: Introductionmentioning

confidence: 99%

A DNA vaccine targeting VEE virus delivered by needle-free jet-injection protects macaques against aerosol challenge

et al. 2022

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“…While we do not envisage that the five-dose IMRAS regimen will undergo further clinical evaluation, we suggest that the concept of fractional dosing, as well as a delay in the final immunization, may improve vaccine efficacy is becoming better established in malaria and other diseases [20][21][22][23][24]. Recently, a clinical trial of the malaria vaccine RTS,S, usually given in three doses monthly, showed that a delayed fractional dose regimen where the final dose was 20% of the full dose and administered after a six-month interval gave a significant increase in vaccine efficacy [15].…”

Section: Discussionmentioning

confidence: 92%

IMRAS—Immunization with radiation-attenuated Plasmodium falciparum sporozoites by mosquito bite: Cellular immunity to sporozoites, CSP, AMA1, TRAP and CelTOS

et al. 2021

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Background Immunization with radiation-attenuated sporozoites (RAS) by mosquito bites provides >90% sterile protection against Plasmodium falciparum malaria in humans. We conducted a clinical trial based on data from previous RAS clinical trials that suggested that 800–1200 infected bites should induce ~50% protective vaccine efficacy (VE) against controlled human malaria infection (CHMI) administered three weeks after the final immunization. Two cohorts were immunized separately. VE was 55% in Cohort 1 but 90% in Cohort 2, the cohort that received a higher first dose and a reduced (fractional) fifth dose. Immune responses were better boosted by the fractional fifth dose in Cohort 2 and suggested the importance of the fractional fifth dose for increased protection in Cohort 2 responses. Three protected subjects were later boosted and were protected suggesting that protection could be extended to at least 67 weeks. Methods The ex vivo FluoroSpot assay was used to measure peripheral IFN-γ, IL2, and IFN-γ+IL2 responses to PfNF54 sporozoites and malaria antigens CSP, AMA1, TRAP, and CelTOS using pools of synthetic overlapping 15mer peptides spanning each antigen. Results There was no correlation between IFN-γ, IL2, and IFN-γ+IL2 responses to sporozoites and protection, but fold-increases between post-4th and post-5th responses greater than 1.0 occurred mostly in protected subjects. IFN-γ and IL2 responses to TRAP, CelTOS and CSP occurred only in protected subjects. Peripheral IFN-γ, IL2, and IFN-γ+IL2 responses were short-lived and low by 27 weeks post-CHMI but were restored by boosting. Conclusions These studies highlight the importance of vaccine dose and schedule for vaccine efficacy, and suggest that CSP, TRAP, AMA1 and CelTOS may be targets of protective immunity. The correlation between fold-increases in responses and protection should be explored in other vaccine trials. Trial registration ClinicalTrials.gov NCT01994525.

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“… 32 A report after another intradermal fIPV campaign, undertaken in Hyderabad, Pakistan, recorded little experience and incorrect vaccine administration as limitations to the use of N&S. 33 A study conducted in Karachi, Pakistan, during a catch-up campaign supported the feasibility of DSJI use in this context and also reported that 97·6% (578/592) of vaccinators and 99·6% (4792/4813) of caregivers reported a preference for DSJI over the previous experience of intramuscular N&S vaccination. 34 Immunogenicity data were not collected in these campaigns and safety data were limited to the routine passive reporting of adverse events after immunisation.…”

Section: Discussionmentioning

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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Needle-free injectors for mass administration of fractional dose inactivated poliovirus vaccine in Karachi, Pakistan: A survey of caregiver and vaccinator acceptability

Cited by 24 publications

References 10 publications

A DNA vaccine targeting VEE virus delivered by needle-free jet-injection protects macaques against aerosol challenge

A DNA vaccine targeting VEE virus delivered by needle-free jet-injection protects macaques against aerosol challenge

IMRAS—Immunization with radiation-attenuated Plasmodium falciparum sporozoites by mosquito bite: Cellular immunity to sporozoites, CSP, AMA1, TRAP and CelTOS

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

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