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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02769923
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Ali Faisal Saleem, Aga Khan University

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 12, 2016
Last Update Posted Date September 13, 2017
Study Start Date  ICMJE September 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
Difference in immune response against poliovirus type 1, 2 and 3 after 28 days of administration of fractional dose IPV [ Time Frame: up to day 28. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Difference in bleb size after the intradermal injection among three arms [ Time Frame: immediately after injection ]
    The bleb size will measured immediately after the administration of injection using the millimeter scale.
  • Difference in vaccine loss after the intradermal injection among three arms [ Time Frame: immediately after injection ]
    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.
  • Difference in local adverse events [ Time Frame: within 30 minutes after injection ]
    local adverse events include redness, itching, etc.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ID Administration of fIPV Using Intradermal Adapters vs. BCG Syringe
Official Title  ICMJE Intradermal Administration of Fractional Dose of Inactivated Poliovirus Vaccine Using Intradermal Adapters vs. BCG Syringe: Community Based Randomized Control Trial in Pakistan
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE IPV
Intervention  ICMJE
  • Device: Westpharma ID adapter
    device used for administering intradermal injection
  • Device: Star ID syringe
    device used for administering intradermal injection
  • Device: BCG NS
    syringe used for administering intradermal injection
Study Arms  ICMJE
  • Active Comparator: Arm A
    Westpharma ID Adapter
    Intervention: Device: Westpharma ID adapter
  • Active Comparator: Arm B
    Star ID syringe
    Intervention: Device: Star ID syringe
  • Active Comparator: Arm C
    BCG NS
    Intervention: Device: BCG NS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2016)
450
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02769923
Other Study ID Numbers  ICMJE 3519-Ped-ERC-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: in process
Responsible Party Ali Faisal Saleem, Aga Khan University
Study Sponsor  ICMJE Aga Khan University
Collaborators  ICMJE World Health Organization
Investigators  ICMJE
Principal Investigator: Ali F Saleem, FCPS,MSc The Aga Khan University, Karachi
Principal Investigator: Mohammad T Yousafzai, MPH, MSc The Aga Khan University, Karachi
PRS Account Aga Khan University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP