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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Resiquimod gel

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Topical Immune Modulator, resiquimod gel, Hepatitis B booster response, Vaccine Evaluation, Prevention of Hepatitis B disease

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Vancouver General Hospital Vaccine Education Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00175435

First Posted

September 11, 2005

Last Updated

October 29, 2010

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT00175435

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

Topical Immune Modulator, resiquimod gel, Hepatitis B booster response, Vaccine Evaluation, Prevention of Hepatitis B disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

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

Arm Title

2

Arm Type

Active Comparator

Arm Description

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

Arm Title

3

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Resiquimod gel

Other Intervention Name(s)

HPV vaccine - Gardasil

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Resiquimod gel

Other Intervention Name(s)

HPV vaccine = Gardasil

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Resiquimod gel

Other Intervention Name(s)

HPV vaccine = Gardasil

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Dutz, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vancouver General Hospital Vaccine Education Centre

City

Vancouver

State/Province

British Columbia

Country

Canada

Hepatitis B

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial