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

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. Identifier: NCT00219453
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 19, 2007
Bill and Melinda Gates Foundation
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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.

Condition or disease Intervention/treatment Phase
Virus Diseases Hepatitis B Device: Jet Injector with Protector Cap (HSI-500) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : October 2004
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Evaluation of injection site reactions by observation and self-report of pain on a scale (none, mild, moderate, severe)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00219453

Sponsors and Collaborators
Bill and Melinda Gates Foundation
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Study Director: Darin L Zehrung, BS PATH

Additional Information:
Layout table for additonal information Identifier: NCT00219453     History of Changes
Other Study ID Numbers: HS243
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007
Keywords provided by PATH:
Pilot Projects
Injections, Jet
Injections, Jet/instrumentation
Equipment Contamination/prevention and control
Blood-Borne Pathogens
Disease Transmission, Horizontal
Additional relevant MeSH terms:
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Hepatitis B
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Hepadnaviridae Infections
DNA Virus Infections