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Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination

Primary Purpose

Virus Diseases, Hepatitis B

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Jet Injector with Protector Cap (HSI-500)
Sponsored by
PATH
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Virus Diseases focused on measuring Pilot Projects, Injections, Jet, Injections, Jet/instrumentation, Equipment Contamination/prevention and control, Blood-Borne Pathogens, Disease Transmission, Horizontal

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Between the age of 18 and 60 years. Either male or female. In good health, by self-report and confirmed by physical exam. Willing and able to follow procedural requirements of the study. Willing and able to provide informed consent for study participation. Ability to read and understand informed consent information sheet in English. For Hepatitis B Positive Volunteers Actively infected with blood levels of greater than or equal to 10*6 hepatits B virus (HBV) copies/mL, confirmed by HBV DNA blood test conducted up to 21 days prior to the day of study enrollment (existing patient record) Not presently taking any heparin-based drugs that could potentially interfere with HBV assays. For Hepatitis B Negative Volunteers Not actively infected with HBV as confirmed by HBV tests. Not presently taking any drugs that could potentially interfere with HBV assays. No prior history of HBV infection. Exclusion Criteria: Requires anti-viral HBV therapy. History of allergic reactions or anaphylaxis to immunizations. Dermatological conditions affecting the injection site (such as eczema). Blood coagulation disorders or history of taking drugs that affect blood coagulation. Presently taking any heparin-based medication (Calciparine, Liquaemin Sodium, Hep-Lock, or Hep-Lock U/P) that could potentially interfere with HBV assays. History of severe psychiatric disease. Previous suicidal attempt or hospitalization for psychiatric episode within the last 24 weeks. Any other conditions or circumstances that, in the opinion of the investigator, may be a threat to the safety and welfare of the volunteer.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Presence of hepatitis B virus in post-injection saline samples as verified by a polymerase chain reaction (PCR)-based assay

    Secondary Outcome Measures

    Evaluation of injection site reactions by observation and self-report of pain on a scale (none, mild, moderate, severe)

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    April 18, 2007
    Sponsor
    PATH
    Collaborators
    Bill and Melinda Gates Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00219453
    Brief Title
    Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination
    Official Title
    A Pilot Safety Study to Determine the Presence of Hepatitis B Virus in Downstream Injection Samples Using the HSI-500 Jet Injector With Protector Cap
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    PATH
    Collaborators
    Bill and Melinda Gates Foundation

    4. Oversight

    5. Study Description

    Brief Summary
    The primary purpose of this study is to determine the ability of the Protector Cap Jet Injector to prevent cross-contamination in the next injection sample. The hypothesis is that the Protector Cap Jet Injector will prevent contamination in the next injection sample, even following injection of volunteers with high levels of hepatitis B virus.
    Detailed Description
    The jet injector is a needle-free injection device that uses a high-pressure stream to penetrate the skin and deliver medication into intradermal, subcutaneous, or intramuscular tissues. Multi-dose jet injectors are a type of jet injector with a reusable fluid path that consists of the vial adapter, dose chamber, fluid pathway, and nozzle. Although credited with decades of use and the delivery of millions of doses of vaccine in the field, multi-dose jet injectors are no longer used due to evidence of cross-contamination between injections. The HSI-500 Jet Injector with Protector Cap has been designed with a disposable plastic cap that acts as a shield between the nozzle and the skin to eliminate cross-contamination between injections while maintaining a high rate of vaccine delivery to multiple patients. The objective of this pilot safety study is to provide a preliminary indication of the ability of the jet injector to prevent cross-contamination from hepatitis B virus between volunteer injections. A secondary objective of the study is to test study procedures prior to a larger-scale safety study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Virus Diseases, Hepatitis B
    Keywords
    Pilot Projects, Injections, Jet, Injections, Jet/instrumentation, Equipment Contamination/prevention and control, Blood-Borne Pathogens, Disease Transmission, Horizontal

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    17 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Jet Injector with Protector Cap (HSI-500)
    Primary Outcome Measure Information:
    Title
    Presence of hepatitis B virus in post-injection saline samples as verified by a polymerase chain reaction (PCR)-based assay
    Secondary Outcome Measure Information:
    Title
    Evaluation of injection site reactions by observation and self-report of pain on a scale (none, mild, moderate, severe)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Between the age of 18 and 60 years. Either male or female. In good health, by self-report and confirmed by physical exam. Willing and able to follow procedural requirements of the study. Willing and able to provide informed consent for study participation. Ability to read and understand informed consent information sheet in English. For Hepatitis B Positive Volunteers Actively infected with blood levels of greater than or equal to 10*6 hepatits B virus (HBV) copies/mL, confirmed by HBV DNA blood test conducted up to 21 days prior to the day of study enrollment (existing patient record) Not presently taking any heparin-based drugs that could potentially interfere with HBV assays. For Hepatitis B Negative Volunteers Not actively infected with HBV as confirmed by HBV tests. Not presently taking any drugs that could potentially interfere with HBV assays. No prior history of HBV infection. Exclusion Criteria: Requires anti-viral HBV therapy. History of allergic reactions or anaphylaxis to immunizations. Dermatological conditions affecting the injection site (such as eczema). Blood coagulation disorders or history of taking drugs that affect blood coagulation. Presently taking any heparin-based medication (Calciparine, Liquaemin Sodium, Hep-Lock, or Hep-Lock U/P) that could potentially interfere with HBV assays. History of severe psychiatric disease. Previous suicidal attempt or hospitalization for psychiatric episode within the last 24 weeks. Any other conditions or circumstances that, in the opinion of the investigator, may be a threat to the safety and welfare of the volunteer.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Darin L Zehrung, BS
    Organizational Affiliation
    PATH
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=556
    Description
    August 9, 2005 FDA Safety Panel meeting information: agenda, meeting transcript, questions, and other supporting documentation.

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    Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination

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