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 ]

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 ]

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
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 Arms

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

Sex/Gender

Sexes Eligible for Study:

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

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

PRS Account

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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