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

University of British Columbia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatitis B

Treatments: Biological: Resiquimod gel

Study type: Interventional

Funder types: Other

Identifiers

NCT00175435

C05-0027

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 3 patient groups

1

Experimental group

Description:

2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds.

Treatment:

Biological: Resiquimod gel

Biological: Resiquimod gel

Biological: Resiquimod gel

2

Active Comparator group

Description:

3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds.

Treatment:

Biological: Resiquimod gel

Biological: Resiquimod gel

Biological: Resiquimod gel

3

Active Comparator group

Description:

3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds.

Treatment:

Biological: Resiquimod gel

Biological: Resiquimod gel

Biological: Resiquimod gel