ID Administration of fIPV Using Intradermal Adapters vs. BCG Syringe

NCT02769923 | Completed DMC

• 1 other identifier: 3519-Ped-ERC-15
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators will assess the usability and immune response following fractional dose inactivated polio virus vaccine (fIPV) administration with two novel intradermal adapters (ID adapter by West Pharmaceutical services Inc. and Star Intradermal syringe by Star Syringe Ltd.) and compare the response with the one achieved with fIPV administered with traditional BCG needle syringe.

Conditions

IPV

Keywords

WestPharma ID-adapter; Star ID syringe; BCG needle syringe; fractional dose IPV; fIPV; polio; Polio Endgame; IPV

Outcome Measures

Primary Outcomes (1)

• Difference in immune response against poliovirus type 1, 2 and 3 after 28 days of administration of fractional dose IPV

  Seropositivity is defined as reciprocal titers of poliovirus neutralizing antibodies \>8; seroconversion is defined as the change from seronegative to seropositive (from reciprocal titer of \<8 to \>8); and boosting is defined as \>4-fold increase in titers. In this study, "immune response" combines both boosting and seroconversion.

  up to day 28.

Secondary Outcomes (3)

• Difference in bleb size after the intradermal injection among three arms

  immediately after injection

• Difference in vaccine loss after the intradermal injection among three arms

  immediately after injection

• Difference in local adverse events

  within 30 minutes after injection

Study Arms (3)

Arm A

ACTIVE COMPARATOR

Westpharma ID Adapter

Device: Westpharma ID adapter

Arm B

ACTIVE COMPARATOR

Star ID syringe

Device: Star ID syringe

Arm C

ACTIVE COMPARATOR

BCG NS

Device: BCG NS

Interventions

Westpharma ID adapter DEVICE

device used for administering intradermal injection

Arm A

Star ID syringe DEVICE

device used for administering intradermal injection

Arm B

BCG NS DEVICE

syringe used for administering intradermal injection

Arm C

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-12 months living in four peri-urban slums of Bin Qasim Town, Karachi (Rehri Goth, Bhains Colony, Ali Akber Shah, Ibrahim Hydri).

You may not qualify if:

• Child found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization.
• Refusal of blood testing.
• Any contraindication for ID injection.
• A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family.
• e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.

Sponsors & Collaborators

• Aga Khan University: lead
• World Health Organization: collaborator

MeSH Terms

Conditions

Poliomyelitis

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

Study Officials

• Ali F Saleem, FCPS,MSc

  The Aga Khan University, Karachi

  PRINCIPAL INVESTIGATOR

• Mohammad T Yousafzai, MPH, MSc

  The Aga Khan University, Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 12, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share