Hepatitis BPhase 1/2NCT00175435
Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
A Phase 1/2 study testing Resiquimod gel in people with Hepatitis B, run by University of British Columbia at 1 site in Canada.
Trial summary
This study will look at what happens to the level of protection against hepatitis B (HB) disease if a 'helper' gel is applied to the skin over the injection site of a small dose of hepatitis B vaccine. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Resiquimod gel
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Apr 2007
- Phase
- Phase 1/2
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Previously vaccinated with conventional hepatitis B vaccine series 10 or more years ago
- Generally healthy
- Is and has been free of HB disease and/or is negative to core antibody
- Known to have sero-converted to positive after vaccine series (without extra doses)
- Speaks and understands English adequately
- Available for all 4 visits within the designated timelines (30 days)
Show all 9Show fewer
- No allergies to HB vaccine or components
- No blood or blood components within previous 6 months
- Not pregnant or breastfeeding
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital Vaccine Education Centre
Vancouver, British Columbia
About this study
This study will look at what happens to the level of protection against hepatitis B (HB) disease if a 'helper' gel is applied to the skin over the injection site of a small dose of hepatitis B vaccine.
- Conditions
- Hepatitis B
- Being tested
- Resiquimod gel
- Keywords
- Topical Immune Modulator, resiquimod gel, Hepatitis B booster response, Vaccine Evaluation, Prevention of Hepatitis B disease
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resiquimod gelBiological
Also called HPV vaccine - Gardasil
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
Resiquimod gelBiological
Also called HPV vaccine = Gardasil
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
Resiquimod gelBiological
Also called HPV vaccine = Gardasil
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds. Receives: Biological: Resiquimod gel |
| 2 | Active comparator | 3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds. Receives: Biological: Resiquimod gel |
| 3 | Active comparator | 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds. Receives: Biological: Resiquimod gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
A single application of an immune modulating gel will enhance the protective response against hepatitis B disease when vaccination is given at the same time as gel as evidenced by increased HB antibody and T-cell response.
Measured: at 30 days after vaccination
Secondary outcomes (1)
Minimal adverse effects to gel application as noted by laboratory assessment of liver enzyme and complete blood count (CBC) and physical assessment of the site/surrounding area and solicited local and general post vaccine events.
Measured: at 7 and 30 days post vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Jan Dutz, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175435
- Sponsor's protocol ID
- C05-0027
- Status last verified
- Oct 2010
- First submitted
- 11 Sep 2005
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
- ClinicalTrials.gov ID
- NCT00175435
- Acronym / sponsor ID
- C05-0027
- Conditions
- Hepatitis B
- Keywords
- Topical Immune Modulator, resiquimod gel, Hepatitis B booster response, Vaccine Evaluation, Prevention of Hepatitis B disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 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.
This study will look at what happens to the level of protection against hepatitis B (HB) disease if a 'helper' gel is applied to the skin over the injection site of a small dose of hepatitis B vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Resiquimod gel2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds. |
| 2 | Active comparator | Biological: Resiquimod gel3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds. |
| 3 | Active comparator | Biological: Resiquimod gel3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Previously vaccinated with conventional hepatitis B vaccine series 10 or more years ago
- Generally healthy
- Is and has been free of HB disease and/or is negative to core antibody
- Known to have sero-converted to positive after vaccine series (without extra doses)
- Speaks and understands English adequately
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Resiquimod gelAlso: HPV vaccine - Gardasil3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator | Biological | 1 |
| Resiquimod gelAlso: HPV vaccine = Gardasil3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator. | Biological | 2 |
| Resiquimod gelAlso: HPV vaccine = Gardasil3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator. | Biological | 3 |
Primary outcome
A single application of an immune modulating gel will enhance the protective response against hepatitis B disease when vaccination is given at the same time as gel as evidenced by increased HB antibody and T-cell response.
Time frame: at 30 days after vaccination
1 secondary outcome
Minimal adverse effects to gel application as noted by laboratory assessment of liver enzyme and complete blood count (CBC) and physical assessment of the site/surrounding area and solicited local and general post vaccine events.
Time frame: at 7 and 30 days post vaccine
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 2 Nov 2010.
Related trials for Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingObservational study
Evaluation of Non-Invasive Tests for Metabolic Liver Disease
Metabolic Associated Fatty Liver Disease, Metabolic Associated Steatotic Liver Disease
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
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.
Jan Dutz, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Resiquimod gel in people with Hepatitis B, run by University of British Columbia at 1 site in Canada.
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 9 inclusion and 0 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 2 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
A single application of an immune modulating gel will enhance the protective response against hepatitis B disease when vaccination is given at the same time as gel as evidenced by increased HB antibody and T-cell response. (time frame: at 30 days after vaccination). 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 2 Nov 2010; AzTrials last refreshed its copy on 26 Oct 2026.