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Effectiveness of Hepatitis A Virus Vaccination Among Homosexual Males at Risk for Hepatitis A Infection

Primary Purpose

Hepatitis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hepatitis A vaccine
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis focused on measuring hepatitis A vaccine, male homosexual, HIV infection, male homosexuals who are seronegative for hepatitis A virus

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 18~40-years-old
  • Homosexuals

Exclusion Criteria:

  • Presence of symptoms or signs suggestive of active infection
  • Allergy to vaccination
  • Failure to provide written informed consent
  • Use of immunosuppressive or immunomodulating agents or chemotherapy

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

male homosexuals

HIV-infected male homosexuals, group1

HIV-infected male homosexuals, group 2

Arm Description

HIV-uninfected male homosexuals will be provided 2 doses of HAV vaccine, which will be administered at baseline and 6th month of follow-up.

HIV-infected male homosexuals will be provided 3 doses of HAV vaccine, which will be administered at baseline, 1st, and 6th month of follow-up.

HIV-infected male homosexuals will be provided 2 doses of hepatitis A vaccine, which will be administered at baseline and 6th month of follow-up.

Outcomes

Primary Outcome Measures

the proportion of vaccinees who achieve anti-HAV antibody concentrations of 20 mIU/ml or greater at week 48 of vaccination

Secondary Outcome Measures

the concentrations of anti-HAV antibody at week 48 of vaccination

Full Information

First Posted
January 8, 2010
Last Updated
December 25, 2012
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01102296
Brief Title
Effectiveness of Hepatitis A Virus Vaccination Among Homosexual Males at Risk for Hepatitis A Infection
Official Title
Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Male homosexuals are at risk for hepatitis A virus (HAV) infection, and HAV vaccination has been recommended to prevent HAV infection in male homosexuals. HIV infection may impair serological responses to HAV vaccination in HIV-infected patients. The investigators hypothesize that 3 doses of HAV vaccine will improve serological responses to HAV vaccine in HIV-infected patients.
Detailed Description
In this study, we aim to compare the serological responses to HAV vaccination between HIV-infected patients who receive 2 doses or 3 doses of HAV vaccine and HIV-uninfected persons who receive 2 doses of HAV vaccine. Persons who identify themselves as male homosexuals aged younger than 40 years and are seronegative for hepatitis A virus will be enrolled. HAV vaccination will be provided free-of-charge. HIV-uninfected persons will receive 2 doses of HAV vaccine that will be administered at baseline and 6 months after the first dose, while HIV-infected patients will be given 2 doses or 3 doses of HAV vaccine; for those who choose to receive 3 doses, a second dose will be given 1 month after the first dose. A longitudinal follow-up of serological responses will be conducted to assess the effectiveness of HAV vaccination; HAV IgG will be determined at 6 months after the first dose of HAV vaccination(before the administration of the second dose), 12 months and 18 months after the first dose of HAV vaccination .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis
Keywords
hepatitis A vaccine, male homosexual, HIV infection, male homosexuals who are seronegative for hepatitis A virus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
582 (Actual)

8. Arms, Groups, and Interventions

Arm Title
male homosexuals
Arm Type
Active Comparator
Arm Description
HIV-uninfected male homosexuals will be provided 2 doses of HAV vaccine, which will be administered at baseline and 6th month of follow-up.
Arm Title
HIV-infected male homosexuals, group1
Arm Type
Active Comparator
Arm Description
HIV-infected male homosexuals will be provided 3 doses of HAV vaccine, which will be administered at baseline, 1st, and 6th month of follow-up.
Arm Title
HIV-infected male homosexuals, group 2
Arm Type
Active Comparator
Arm Description
HIV-infected male homosexuals will be provided 2 doses of hepatitis A vaccine, which will be administered at baseline and 6th month of follow-up.
Intervention Type
Biological
Intervention Name(s)
Hepatitis A vaccine
Other Intervention Name(s)
HAVRIX (1440 ELISA unit)per dose., MSM
Intervention Description
2 or 3 doses of hepatitis A vaccine to HIV-infected male homosexuals and 2 doses of hepatitis A vaccine to HIV-uninfected male homosexuals.
Primary Outcome Measure Information:
Title
the proportion of vaccinees who achieve anti-HAV antibody concentrations of 20 mIU/ml or greater at week 48 of vaccination
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
the concentrations of anti-HAV antibody at week 48 of vaccination
Time Frame
48 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18~40-years-old Homosexuals Exclusion Criteria: Presence of symptoms or signs suggestive of active infection Allergy to vaccination Failure to provide written informed consent Use of immunosuppressive or immunomodulating agents or chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Ching Hung, MD
Organizational Affiliation
Division of Infectious Disease, Department of Internal Medicine, National Taiwan University Hopsital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Effectiveness of Hepatitis A Virus Vaccination Among Homosexual Males at Risk for Hepatitis A Infection

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