Hepatitis BPhase 4HVSNCT01259453
Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
A Phase 4 study testing Vaccination to prevent hepatitis B virus infection in people with Hepatitis B, run by Yale University at 3 sites in United States.
Trial summary
The investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high risk individuals… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Vaccination to prevent hepatitis B virus infection
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 595 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2003to Aug 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrate evidence of recent injection drug use (injection stigmata),
- 18 years of age or older,
- Screened for and found susceptible to HBV
- Able to provide informed consent.
Who cannot join
- Evidence of intoxication that prevented provision of informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DePaul University
Chicago, Illinois, 60614
Case Western Reserve Universtiy
Cleveland, Ohio, 44106
Hispanic Health Council
Hartford, Connecticut, 06106
About this study
The investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The primary purpose of the study is to compare the standard schedule of hepatitis B vaccination at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The investigators hypothesize that the accelerated scheduling will result in improved completion rates without significant loss in vaccine efficacy.
- Conditions
- Hepatitis B
- Being tested
- Vaccination to prevent hepatitis B virus infection
- Keywords
- Hepatitis B vaccination, Syringe exchange programs, Injection drug users, Hepatitis B prevention through vaccination
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination to prevent hepatitis B virus infectionBiological
Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule
| Study group | Role | What they receive |
|---|---|---|
| Standard vaccination schedule | Active comparator | Standard dosing at 0, 1, and 6 months Receives: Biological: Vaccination to prevent hepatitis B virus infection |
| Accelerated Schedule | Active comparator | Accelerated dosing at 0, 1, and 2 months Receives: Biological: Vaccination to prevent hepatitis B virus infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Efficacy
Measured: 8 months from study enrollment
Secondary outcomes (2)
Vaccine completion rate
Measured: 8 months from study enrollment
Association of exchange status with completion
Measured: 8 months from study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startMay 2003
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- DePaul University, Hispanic Health Council, Inc., Case Western Reserve University, National Institute on Drug Abuse (NIDA)
- Investigators
- Robert Heimer, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259453
- Sponsor's protocol ID
- 0005011791
- Other IDs
- 5R01DA014502
- Acronym
- HVS
- Status last verified
- Dec 2010
- First submitted
- 10 Dec 2010
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hu Y, Grau LE, Scott G, Seal KH, Marshall PA, Singer M, Heimer R. Economic evaluation of delivering hepatitis B vaccine to injection drug users. Am J Prev Med. 2008 Jul;35(1):25-32. doi: 10.1016/j.amepre.2008.03.028.
PubMed 18541174
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
- ClinicalTrials.gov ID
- NCT01259453
- Acronym / sponsor ID
- HVS / 0005011791
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B vaccination, Syringe exchange programs, Injection drug users, Hepatitis B prevention through vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- DePaul University, Hispanic Health Council, Inc., Case Western Reserve University, National Institute on Drug Abuse (NIDA)
- Study start
- May 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 14 Dec 2010 (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 investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The primary purpose of the study is to compare the standard schedule of hepatitis B vaccination at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The investigators hypothesize that the accelerated scheduling will result in improved completion rates without significant loss in vaccine efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard vaccination schedule | Active comparator | Biological: Vaccination to prevent hepatitis B virus infectionStandard dosing at 0, 1, and 6 months |
| Accelerated Schedule | Active comparator | Biological: Vaccination to prevent hepatitis B virus infectionAccelerated dosing at 0, 1, and 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Demonstrate evidence of recent injection drug use (injection stigmata),
- 18 years of age or older,
- Screened for and found susceptible to HBV
- Able to provide informed consent.
Key exclusion criteria (1 listed)
- Evidence of intoxication that prevented provision of informed consent.
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 |
|---|---|---|
| Vaccination to prevent hepatitis B virus infectionStandard dosing with Twinrix; comparison of standard and acceleration dosing schedule | Biological | Accelerated Schedule, Standard vaccination schedule |
Primary outcome
Vaccine Efficacy
Time frame: 8 months from study enrollment
2 secondary outcomes
Vaccine completion rate
Time frame: 8 months from study enrollment
Association of exchange status with completion
Time frame: 8 months from study enrollment
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 14 Dec 2010.
- Results publication: PubMed 18541174Hu Y, Grau LE, Scott G, Seal KH, Marshall PA, Singer M, Heimer R. Economic evaluation of delivering hepatitis B vaccine to injection drug users. Am J Prev Med. 2008 Jul;35(1):25-32. doi: 10.1016/j.amepre.2008.03.028.
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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.
Robert Heimer, Ph.D. principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccination to prevent hepatitis B virus infection in people with Hepatitis B, run by Yale University at 3 sites in United States.
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 4 inclusion and 1 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 14 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Vaccine Efficacy (time frame: 8 months from study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01259453, which also lists 1 linked publication.
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 14 Dec 2010.