Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175435

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 I Phase II

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Resiquimod

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator

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 ]

Estimated Enrollment:	39
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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.
3: Active Comparator 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.

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

Contacts

Contact: Carol LaJeunesse, CRC

604.875.2757

clajeunesse@cw.bc.ca

Locations

Canada, British Columbia
Vancouver General Hospital Vaccine Education Centre	Recruiting
Vancouver, British Columbia, Canada
Contact: Carol LaJeunesse 604.875.2635 clajeunesse@cw.bc.ca

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Jan Dutz, MD

University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Jan Dutz )
Study ID Numbers:	C05-0027
Study First Received:	September 11, 2005
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00175435
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

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009