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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Resiquimod gel
* Biological: Resiquimod gel
* Biological: Resiquimod gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds. | Biological: Resiquimod gel<br>* 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator<br>* Other names: HPV vaccine - Gardasil;|
| Active Comparator: 2<br>3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds. | Biological: Resiquimod gel<br>* 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.<br>* Other names: HPV vaccine = Gardasil;|
| Active Comparator: 3<br>3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds. | Biological: Resiquimod gel<br>* 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.<br>* Other names: HPV vaccine = Gardasil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical Immune Modulator, resiquimod gel, Hepatitis B booster response, Vaccine Evaluation, Prevention of Hepatitis B disease