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

October 29, 2010 updated by: University of British Columbia
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital Vaccine Education Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds.
Biological: Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
Other Names:
  • HPV vaccine - Gardasil
Biological: Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
Other Names:
  • HPV vaccine = Gardasil
ACTIVE_COMPARATOR: 2
3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds.
Biological: Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
Other Names:
  • HPV vaccine - Gardasil
Biological: Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
Other Names:
  • HPV vaccine = Gardasil
ACTIVE_COMPARATOR: 3
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds.
Biological: Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
Other Names:
  • HPV vaccine - Gardasil
Biological: Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
Other Names:
  • HPV vaccine = Gardasil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at 30 days after vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at 7 and 30 days post vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Jan Dutz, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2010

Last Update Submitted That Met QC Criteria

October 29, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C05-0027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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