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

Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102296
• Other study ID #: 200903063M
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: December 25, 2012
• Start date: June 2009
• Est. completion date: April 2012

Study information

• Verified date: December 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 582
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of vaccinees who achieve anti-HAV antibody concentrations of 20 mIU/ml or greater at week 48 of vaccination		48 weeks	Yes
Secondary	the concentrations of anti-HAV antibody at week 48 of vaccination		48 weeks	Yes