Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator

NCT ID: NCT00175435

Last Updated: 2010-11-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B

Keywords

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Topical Immune Modulator resiquimod gel Hepatitis B booster response Vaccine Evaluation Prevention of Hepatitis B disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type EXPERIMENTAL

Resiquimod gel

Intervention Type BIOLOGICAL

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.

Group Type ACTIVE_COMPARATOR

Resiquimod gel

Intervention Type BIOLOGICAL

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.

Group Type ACTIVE_COMPARATOR

Resiquimod gel

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Resiquimod gel

3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.

Intervention Type BIOLOGICAL

Resiquimod gel

3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.

Intervention Type BIOLOGICAL

Other Intervention Names

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HPV vaccine - Gardasil HPV vaccine = Gardasil HPV vaccine = Gardasil

Eligibility Criteria

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Inclusion Criteria

* 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)
* No allergies to HB vaccine or components
* No blood or blood components within previous 6 months
* Not pregnant or breastfeeding
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

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

Site Status

Countries

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Canada

Other Identifiers

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C05-0027

Identifier Type: -

Identifier Source: org_study_id