A Campaign-based ID fIPV Administration Trial

NCT02967783 | Completed

• 1 other identifier: SCC1495
• Study Type: interventional
• Target: 2,721
• Locations: 1 country
• Sites: 1

Brief Summary

The introduction of one dose of the inactivated poliovirus vaccine (IPV) into routine immunization schedules in OPV-only using countries as part of the Global Polio Eradication Initiative (GPEI) was planned for completion in 2016. However, due to recent developments in the global IPV supply landscape, the GPEI polio eradication program is facing a critical shortage of the vaccine which is forecast to continue until at least the end of 2017. The shortage means that some countries that have already introduced the vaccine, but which are considered to be relatively low risk (The Gambia included), will be left without adequate supplies and in other countries IPV introduction is being unavoidably delayed. Exacerbating the shortage is the need to reserve IPV for future outbreak responses (OBR). The current OBR protocol recommends that, if a circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreak occurs (after the recent global switch from trivalent to bivalent OPV), a large scale IPV campaign will be implemented to increase population immunity to the type 2 poliovirus in an large area surrounding the outbreak as high risk of extending transmission. Due to above, dose-sparing through the administration of intra-dermal (ID) fractional (one fifth - 0.1mL) doses of IPV (fIPV) has become a very important focus and, for planning purposes, there is an urgent need to assess the practical and logistic challenges a country such as The Gambia would face in rapidly undertaking an ID fIPV campaign.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (12)

• Total time taken to deliver ID fIPV using each of the three methods of administration

  Collected on day 1, 2 or 3 of the vaccination campaign

• Qualitative measures of administration method utility

  Ergonomic characteristics of the intradermal administration methods collected through questionnaires

  Collected on day 1, 2 or 3 of the vaccination campaign

• Local and systemic reactogenicity collected according to standard severity score (0 - 4) system.

  Local reactogenicity (induration, erythema, tenderness, fever, vomiting, diarrhoea, feeding, irritability) will be collected on all vaccines on day 3 following vaccine administration

  Day 3 following vaccination

• Serious adverse events (SAE) and adverse events (AE) following ID fIPV administration

  Within 4 weeks of vaccination

• Semi-quantitative measure of distress in infants and children associated with ID fIPV administration

  Infant distress will be graded according to a visual analogue scale

  Collected on day 1, 2 or 3 of the vaccination campaign

• Storage volumes of equipment required for ID fIPV delivery and subsequent bio-waste disposal including any differences the equipment required to safely deliver such vaccinations in a campaign

  The volume of the disposables and biowaste created by each of the administration methods will be recorded.

  Collected on day 1, 2 or 3 of the vaccination campaign

• Number of ID fIPV doses deliverable per IPV vial using each of the three administration methods (to identify any wastage associated with syringe/device filling)

  Collected on day 1, 2 or 3 of the vaccination campaign

• Immune response to ID fIPV (poliovirus neutralization assays)

  Poliovirus neutralization assays

  Serum sample taken at baseline (pre-vaccination) and 4 weeks following vaccination

• Changes in the time taken to deliver the ID fIPV and in the immune responses generated over the course of a 3 day campaign

  Over 3 days of the campaign

• Changes in the vaccine vial monitors (VVM) and also temperature deviations identified using a continuous temperature data logger associated with a campaign using each of the three administration methods

  Over 3 days of the campaign

• Qualitative factors which might influence campaign uptake in The Gambia and comparable sub-Saharan African settings

  1 week following vaccination campaign

• Number of ID fIPV doses delivered using each of the three methods in the course of a defined campaign day by one vaccination team

  Collected on day 1, 2 or 3 of the vaccination campaign

Study Arms (3)

ID Needle and Syringe

ACTIVE COMPARATOR

Fractional (0.1mL) dose of inactivated poliovirus vaccine (IPV) administered using a needle and syringe

Device: Needle and syringe

ID Adaptor (Helm)

EXPERIMENTAL

Fractional (0.1mL) dose of inactivated poliovirus vaccine (IPV) administered using a needle and syringe with an ID adaptor

Device: ID adaptor

ID Jet Injector (Tropis, Pharmajet)

EXPERIMENTAL

Fractional (0.1mL) dose of inactivated poliovirus vaccine (IPV) administered by needle and syringe with a disposable syringe jet injecto

Device: ID Jet Injector (Tropis, Pharmajet)

Interventions

ID adaptor DEVICE

ID adaptor fixed to the end of a standard ID needle and syringe to facilitate ID administration of the inactivated poliovirus vaccine

ID Adaptor (Helm)

ID Jet Injector (Tropis, Pharmajet) DEVICE

ID disposable syringe (needle free) jet injector to facilitate ID administration of the inactivated poliovirus vaccine

ID Jet Injector (Tropis, Pharmajet)

Needle and syringe DEVICE

Standard ID needle and syringe for ID administration of the inactivated poliovirus vaccine

ID Needle and Syringe

Eligibility Criteria

• Age: 4 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written or thumb-printed informed consent obtained from a child's parent or guardian
• Resident within the geographical area which is expected to be covered by the campaign
• Between 4 and 59 months of age at the time of the campaign

You may not qualify if:

• Anaphylaxis or a severe, potentially life threatening, allergic reaction to a previous vaccination

Sponsors & Collaborators

• Medical Research Council Unit, The Gambia: lead
• World Health Organization: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

MRC Unit The Gambia

Banjul, The Gambia

Location

Related Publications (1)

• Bashorun AO, Badjie Hydara M, Adigweme I, Umesi A, Danso B, Johnson N, Sambou NA, Fofana S, Kanu FJ, Jeyaseelan V, Verma H, Weldon WC, Oberste MS, Sutter RW, Jeffries D, Wathuo M, Mach O, Clarke E. Intradermal administration of fractional doses of the inactivated poliovirus vaccine in a campaign: a pragmatic, open-label, non-inferiority trial in The Gambia. Lancet Glob Health. 2022 Feb;10(2):e257-e268. doi: 10.1016/S2214-109X(21)00497-6. Epub 2021 Dec 21.

  PMID: 34951974 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Interventions

Needles; Syringes

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Ed Clarke, MRCPCH MSc PhD

  MRC Unit The Gambia

  PRINCIPAL INVESTIGATOR

• Adedapo O Bashorun, MBBS

  MRC Unit The Gambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: six vaccination teams will be randomly assigned to administer the three different ID fIPV administration technique the campaign days
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: November 18, 2016
• Study Start: February 7, 2017
• Primary Completion: July 10, 2017
• Study Completion: September 18, 2018
• Last Updated: January 3, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)