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

Tracking Information
First Submitted Date ICMJE	January 8, 2010
First Posted Date ICMJE	April 13, 2010
Last Update Posted Date	December 27, 2012
Study Start Date ICMJE	June 2009
Actual Primary Completion Date	March 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 12, 2010)	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; (submitted: April 12, 2010)	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 Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (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
Actual Enrollment ICMJE; (submitted: December 25, 2012)	582
Original Estimated Enrollment ICMJE; (submitted: April 12, 2010)	300
Actual Study Completion Date	April 2012
Actual 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