Effectiveness of Hepatitis A Virus Vaccination Among Homosexual Males at Risk for Hepatitis A Infection
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ClinicalTrials.gov Identifier: NCT01102296 |
Recruitment Status
:
Completed
First Posted
: April 13, 2010
Last Update Posted
: December 27, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis | Biological: Hepatitis A vaccine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 582 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
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.
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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:
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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.
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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:
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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.
|
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:
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- 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 ]
- the concentrations of anti-HAV antibody at week 48 of vaccination [ Time Frame: 48 weeks ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102296
Taiwan | |
National Taiwan University Hospital | |
Taipei, Taiwan |
Principal Investigator: | Chien-Ching Hung, MD | Division of Infectious Disease, Department of Internal Medicine, National Taiwan University Hopsital |
Responsible Party: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT01102296 History of Changes |
Other Study ID Numbers: |
200903063M |
First Posted: | April 13, 2010 Key Record Dates |
Last Update Posted: | December 27, 2012 |
Last Verified: | December 2012 |
Keywords provided by National Taiwan University Hospital:
hepatitis A vaccine male homosexual HIV infection male homosexuals who are seronegative for hepatitis A virus |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Vaccines Immunologic Factors Physiological Effects of Drugs |