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

January 8, 2010
December 25, 2012
June 2009
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01102296 on ClinicalTrials.gov Archive Site
the concentrations of anti-HAV antibody at week 48 of vaccination [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Hepatitis A Virus Vaccination Among Homosexual Males at Risk for Hepatitis A Infection
Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital

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.

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 .

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis
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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
582
April 2012
March 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01102296
200903063M
Yes
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Chien-Ching Hung, MD Division of Infectious Disease, Department of Internal Medicine, National Taiwan University Hopsital
National Taiwan University Hospital
December 2012

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