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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT01102296

First received: January 8, 2010

Last updated: December 25, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 8, 2010

Last Updated Date

December 25, 2012

Start Date ^ICMJE

June 2009

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01102296 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

the concentrations of anti-HAV antibody at week 48 of vaccination [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital

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 .

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Hepatitis

Intervention ^ICMJE

Biological: Hepatitis A vaccine

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.

Other Names:

HAVRIX (1440 ELISA unit)per dose.
MSM

Study Arm (s)

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

Intervention: Biological: Hepatitis A vaccine
Active Comparator: HIV-infected male homosexuals, group1
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.

Intervention: Biological: Hepatitis A vaccine
Active Comparator: HIV-infected male homosexuals, group 2
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: Biological: Hepatitis A vaccine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

582

Completion Date

April 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 40 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Taiwan

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01102296

Other Study ID Numbers ^ICMJE

200903063M

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

National Taiwan University Hospital

Study Sponsor ^ICMJE

National Taiwan University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Chien-Ching Hung, MD

Division of Infectious Disease, Department of Internal Medicine, National Taiwan University Hopsital

Information Provided By

National Taiwan University Hospital

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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