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

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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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vancouver General Hospital Vaccine Education Centre

Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resiquimod gel

Biological

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

Other names: HPV vaccine - Gardasil

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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Sep 15, 2005
Registry last updated: Nov 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed