A Phase 1 interventional study of Jet Injector with Protector Cap (HSI-500) in Virus Diseases and Hepatitis B, sponsored by PATH. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-04-19.
Sponsored by PATH · Phase 1, Interventional, and Prevention
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.
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.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 17 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →PATH is the lead sponsor of 111 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
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For Hepatitis B Positive Volunteers
For Hepatitis B Negative Volunteers
Exclusion Criteria:
Presence of hepatitis B virus in post-injection saline samples as verified by a polymerase chain reaction (PCR)-based assay
Evaluation of injection site reactions by observation and self-report of pain on a scale (none, mild, moderate, severe)
No study locations are listed for this record.
This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.
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