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

April 18, 2007 updated by: PATH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

17

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PATH

Collaborators

Bill and Melinda Gates Foundation

Investigators

  • Study Director: Darin L Zehrung, BS, PATH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 19, 2007

Last Update Submitted That Met QC Criteria

April 18, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS243

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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