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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175435
• Other study ID #: C05-0027
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 11, 2005
• Last updated: October 29, 2010
• Start date: August 2005
• Est. completion date: April 2007

Study information

• Verified date: October 2010
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator
• Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
• Resiquimod gel
3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital Vaccine Education Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No