Hepatitis B
Conditions
Keywords
Topical Immune Modulator, resiquimod gel, Hepatitis B booster response, Vaccine Evaluation, Prevention of Hepatitis B disease
Brief summary
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.
Interventions
BIOLOGICALResiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Canada
Outcome results
None listed