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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds. |
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| 2 | Active Comparator | 3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds. |
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| 3 | Active Comparator | 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resiquimod gel | Biological | 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator |
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| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Dutz, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital Vaccine Education Centre | Vancouver | British Columbia | Canada |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| Resiquimod gel | Biological | 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator. |
|
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| Resiquimod gel | Biological | 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator. |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |