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
  Purpose

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.


Condition Intervention
Hepatitis
Biological: Hepatitis A vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 582
Study Start Date: June 2009
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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
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.
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

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102296

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chien-Ching Hung, MD Division of Infectious Disease, Department of Internal Medicine, National Taiwan University Hopsital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01102296     History of Changes
Other Study ID Numbers: 200903063M
Study First Received: January 8, 2010
Last Updated: December 25, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
hepatitis A vaccine
male homosexual
HIV infection
male homosexuals who are seronegative for hepatitis A virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on July 31, 2014