A Campaign-based ID fIPV Administration Trial

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

Interventions

DEVICE

ID adaptor

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

DEVICE

ID Jet Injector (Tropis, Pharmajet)

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

DEVICE

Needle and syringe

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

Sponsors & Collaborators

• World Health Organization

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Medical Research Council Unit, The Gambia

  lead OTHER

Principal Investigators

• Ed Clarke, MRCPCH MSc PhD · MRC Unit The Gambia

• Adedapo O Bashorun, MBBS · MRC Unit The Gambia

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

4 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-02-07

Primary Completion

2017-07-10

Completion

2018-09-18

Countries

• The Gambia

Study Locations