ID Administration of fIPV Using Intradermal Adapters vs. BCG Syringe (ID-ADAP)

Intradermal Administration of Fractional Dose of Inactivated Poliovirus Vaccine Using Intradermal Adapters vs. BCG Syringe: Community Based Randomized Control Trial in Pakistan

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.

Study Overview

• Status: Completed
• Conditions: IPV
• Intervention / Treatment: Device: Westpharma ID adapter; Device: Star ID syringe; Device: BCG NS

Detailed Description

The study will be conducted in following two phases.

1. Phase I: Ergonometric evaluation and serology: Phase I is based on community based randomized controlled trial with three arms. List of households with child aged 6-12 months will be retrieved from demographic surveillance system. Train CHWs will visit the household and provide relevant information regarding the study to the parents. The children of the parents who provide written informed consent will be screened for eligibility and enrolled into the study. The children accompanied with parents/guardians will be carried to the primary health center of the Dept. of pediatrics and child health, AKU. Baseline 3ml of blood will be collected by trained study phlebotomist in EDT tubes and will be transported to infectious disease research laboratory (IDRL) at AKU. A sample of 450 children will be randomized using sealed envelopes into one of the three study arms. Arm 1, will receive fIPV using WestPharma device, arm 2 will receive fIPV using Star ID syringe and arm 3 will receive fIPV using BCG syringe. The child will be observed for 30 minutes for any adverse event. The research Assistants will interview the parents to fill the socio-demographic questionnaire and vaccinators will fill ergonometric and injection quality questionnaires. The child will be followed after 28 days (4 weeks) of enrollment and another 3ml of blood will be collected by trained phlebotomist. Details of the visit will be recorded in follow-up questionnaire. Both baseline and endline blood samples will be tested for immune response against polio virus 1,2 and 3.
2. Phase II: Pilot campaign demonstration: In this phase, investigators will conduct a door to door campaign in the high risk community to provide fIPV using either WestPharma device or Star ID syringe or BCG needle syringe. In this campaign, any child less than 5 years of age, living in the study area and whose parents provide verbal consent will receive intradermal injection of fIPV using any of the three devices by the trained research assistants. This will be a one day campaign in coordination with provincial polio emergency operation center (EOC). About 300 children will receive fIPV using any of the three devices.

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; Westpharma ID Adapter	Device: Westpharma ID adapter; device used for administering intradermal injection
Active Comparator: Arm B; Star ID syringe	Device: Star ID syringe; device used for administering intradermal injection
Active Comparator: Arm C; BCG NS	Device: BCG NS; syringe used for administering intradermal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in bleb size after the intradermal injection among three arms	The bleb size will measured immediately after the administration of injection using the millimeter scale.	immediately after injection
Difference in vaccine loss after the intradermal injection among three arms	The measurement is performed by blotting the skin with filter paper to collect liquid that was not delivered into the skin or leaked out after injection. The wet spot on the filter paper will be circled and the diameter of the circle compared to a reference template to quantify the amount of liquid present into the following categories: 0 μl, 0 to 5 μl, 5 to 10 μl, 10 to 20 μl, 20 to 40 μl, more than 40 μl.	immediately after injection
Difference in local adverse events	local adverse events include redness, itching, etc.	within 30 minutes after injection

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: World Health Organization
• Investigators: Principal Investigator: Ali F Saleem, FCPS,MSc, The Aga Khan University, Karachi; Principal Investigator: Mohammad T Yousafzai, MPH, MSc, The Aga Khan University, Karachi

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): September 13, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: IPV; polio; fIPV; WestPharma ID-adapter; Star ID syringe; BCG needle syringe; fractional dose IPV; Polio Endgame
• Other Study ID Numbers: 3519-Ped-ERC-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: in process