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

University of British Columbia39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Hepatitis B

Interventions

Resiquimod gelBIOLOGICAL

3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator

Resiquimod gelBIOLOGICAL

3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.

Resiquimod gelBIOLOGICAL

3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Vancouver General Hospital Vaccine Education Centre

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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