NCT00175435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 2, 2010

Status Verified

October 1, 2010

Enrollment Period

1.7 years

First QC Date

September 11, 2005

Last Update Submit

October 29, 2010

Conditions

Hepatitis B

Keywords

Topical Immune Modulatorresiquimod gelHepatitis B booster responseVaccine EvaluationPrevention of Hepatitis B disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (3)

1

EXPERIMENTAL

2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds.

Biological: Resiquimod gel

2

ACTIVE COMPARATOR

3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds.

Biological: Resiquimod gel

3

ACTIVE COMPARATOR

3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds.

Biological: Resiquimod gel

Interventions

Resiquimod gelBIOLOGICAL

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

Also known as: HPV vaccine - Gardasil
1

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital Vaccine Education Centre

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Jan Dutz, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 15, 2005

Study Start

August 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

November 2, 2010

Record last verified: 2010-10

Locations

CA(1)