Virus DiseasesPhase 1NCT00219453
Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination
A Phase 1 study testing Jet Injector with Protector Cap (HSI-500) in people with Virus Diseases and Hepatitis B, run by PATH.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Virus Diseases, Hepatitis B
- What is being tested?
- Jet Injector with Protector Cap (HSI-500)
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jan 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Virus Diseases, Hepatitis B
- Being tested
- Jet Injector with Protector Cap (HSI-500)
- Keywords
- Pilot Projects, Injections, Jet, Injections, Jet/instrumentation, Equipment Contamination/prevention and control, Blood-Borne Pathogens, Disease Transmission, Horizontal
- Medical subject headings
- Virus Diseases, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jet Injector with Protector Cap (HSI-500)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of hepatitis B virus in post-injection saline samples as verified by a polymerase chain reaction (PCR)-based assay
Secondary outcomes (1)
Evaluation of injection site reactions by observation and self-report of pain on a scale (none, mild, moderate, severe)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virus DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Investigators
- Darin L Zehrung, BS, Study director, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219453
- Sponsor's protocol ID
- HS243
- Status last verified
- Apr 2007
- First submitted
- 13 Sep 2005
- Last updated
- 19 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00219453
- Acronym / sponsor ID
- HS243
- Conditions
- Virus Diseases, Hepatitis B
- Keywords
- Pilot Projects, Injections, Jet, Injections, Jet/instrumentation, Equipment Contamination/prevention and control, Blood-Borne Pathogens, Disease Transmission, Horizontal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Oct 2004
- Study completion
- Jan 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jet Injector with Protector Cap (HSI-500) | Device | – |
Primary outcome
Presence of hepatitis B virus in post-injection saline samples as verified by a polymerase chain reaction (PCR)-based assay
1 secondary outcome
Evaluation of injection site reactions by observation and self-report of pain on a scale (none, mild, moderate, severe)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
- August 9, 2005 FDA Safety Panel meeting information: agenda, meeting transcript, questions, and other supporting documentation.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darin L Zehrung, BS study director
PATH
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Jet Injector with Protector Cap (HSI-500) in people with Virus Diseases and Hepatitis B, run by PATH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of hepatitis B virus in post-injection saline samples as verified by a polymerase chain reaction (PCR)-based assay. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2007.