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

NCT01102296 | Completed DMC

• 1 other identifier: 200903063M
• Study Type: interventional
• Target: 582
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis

Keywords

hepatitis A vaccine; male homosexual; HIV infection; male homosexuals who are seronegative for hepatitis A virus

Outcome Measures

Primary Outcomes (1)

• the proportion of vaccinees who achieve anti-HAV antibody concentrations of 20 mIU/ml or greater at week 48 of vaccination

  48 weeks

Secondary Outcomes (1)

• the concentrations of anti-HAV antibody at week 48 of vaccination

  48 weeks

Study Arms (3)

male homosexuals

ACTIVE COMPARATOR

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

HIV-infected male homosexuals, group1

ACTIVE COMPARATOR

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

HIV-infected male homosexuals, group 2

ACTIVE COMPARATOR

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

Interventions

Hepatitis A vaccine BIOLOGICAL

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.

Also known as: HAVRIX (1440 ELISA unit)per dose., MSM

HIV-infected male homosexuals, group 2; HIV-infected male homosexuals, group1; male homosexuals

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18\~40-years-old
• Homosexuals

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hepatitis; Homosexuality, Male; HIV Infections

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Homosexuality; Sexuality; Sexual Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Chien-Ching Hung, MD

  Division of Infectious Disease, Department of Internal Medicine, National Taiwan University Hopsital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: April 13, 2010
• Study Start: June 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

TW (1)