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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

Tracking Information
First Submitted Date  ICMJE September 11, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date November 2, 2010
Study Start Date  ICMJE August 2005
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
Official Title  ICMJE Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis B
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2005)
39
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00175435
Other Study ID Numbers  ICMJE C05-0027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Jan Dutz, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Dutz, MD University of British Columbia
PRS Account University of British Columbia
Verification Date October 2010

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