Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
NCT ID: NCT00175435
Last Updated: 2010-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2005-08-31
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds.
Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
2
3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds.
Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
3
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds.
Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
Interventions
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Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* No allergies to HB vaccine or components
* No blood or blood components within previous 6 months
* Not pregnant or breastfeeding
19 Years
60 Years
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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University of British Columbia
Principal Investigators
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Jan Dutz, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Vancouver General Hospital Vaccine Education Centre
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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C05-0027
Identifier Type: -
Identifier Source: org_study_id