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

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ClinicalTrials.gov Identifier: NCT00175435
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 2, 2010
Sponsor:
Information provided by:
University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Resiquimod gel Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
Study Start Date : August 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: HPV vaccine = Gardasil




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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. [ Time Frame: at 7 and 30 days post vaccine ]


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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175435


Locations
Canada, British Columbia
Vancouver General Hospital Vaccine Education Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Jan Dutz, MD University of British Columbia

Responsible Party: Dr. Jan Dutz, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175435     History of Changes
Other Study ID Numbers: C05-0027
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: October 2010

Keywords provided by University of British Columbia:
Topical Immune Modulator
resiquimod gel
Hepatitis B booster response
Vaccine Evaluation
Prevention of Hepatitis B disease

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs