Status:
COMPLETED
Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination
Lead Sponsor:
PATH
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Virus Diseases
Hepatitis B
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 Je...
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 je...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00219453
Start Date
October 1 2004
End Date
January 1 2006
Last Update
April 19 2007
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