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

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175435
First received: September 11, 2005
Last updated: October 29, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Hepatitis B
 Biological: Resiquimod gel
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: August 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr. Jan Dutz, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175435     History of Changes
Other Study ID Numbers: C05-0027
Study First Received: September 11, 2005
Last Updated: October 29, 2010
Health Authority: Canada: Health Canada

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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013