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

September 11, 2005
October 29, 2010
August 2005
April 2007   (final data collection date for primary outcome measure)
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 ]
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 at 30 days after vaccination in
Complete list of historical versions of study NCT00175435 on ClinicalTrials.gov Archive Site
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 ]
Minimal adverse effects to gel application as noted by laboratory assessment of liver enzyme and CBC and physical assessment of the site/surrounding area and solicited local and general post vaccine events at 7 and 30 days post vaccine
Not Provided
Not Provided
 
Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Hepatitis B
  • Biological: Resiquimod gel
    3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
    Other Name: HPV vaccine - Gardasil
  • Biological: Resiquimod gel
    3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
    Other Name: HPV vaccine = Gardasil
  • Experimental: 1
    2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds.
    Intervention: Biological: Resiquimod gel
  • Active Comparator: 2
    3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds.
    Intervention: Biological: Resiquimod gel
  • Active Comparator: 3
    3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds.
    Intervention: Biological: Resiquimod gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Both
19 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00175435
C05-0027
No
Dr. Jan Dutz, University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Jan Dutz, MD University of British Columbia
University of British Columbia
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP