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

Phase 1

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Resiquimod gel

• Registration Number: NCT00175435
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-15
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-29
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Resiquimod gel	3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds.
3	Resiquimod gel	3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds.
1	Resiquimod gel	2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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.	at 7 and 30 days post vaccine

Trial Locations

Locations (1)

Vancouver General Hospital Vaccine Education Centre; 🇨🇦 Vancouver, British Columbia, Canada