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Completed

NCT Number: NCT01102296

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

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: HAVRIX (1440 ELISA unit)per dose., MSM

Primary outcomes

  1. 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

Secondary outcomes

  1. the concentrations of anti-HAV antibody at week 48 of vaccination

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2010
Registry last updated
Dec 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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