Status:
COMPLETED
Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Hepatitis A
Human Immunodeficiency Virus
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Though HAV is mainly transmitted through the fecal-oral route, infection by sexual intercourse and blood transfusion is also possible. Injection drug users (IDUs) and men who have sex with men (MSM) h...
Detailed Description
Though HAV is mainly transmitted through the fecal-oral route, infection by sexual intercourse and blood transfusion is also possible. Injection drug users (IDUs) and men who have sex with men (MSM) h...
Eligibility Criteria
Inclusion
- HIV-positive individuals aged 20 year or more, and
- Those who had completed at least a primary series of HAV vaccination (i.e. two doses of HAVRIX 1440, 6-12 months apart; or two doses of Vaqta 50U, 6-18 months apart), and
- Those who failed to achieve serological response at least 4 weeks after the last dose of primary HAV vaccination.
Exclusion
- Patients who have acute illness or acute hepatitis A related symptoms (fever, malaise, nausea, vomiting, abdominal discomfort, and jaundice) within 30 days.
- Patients who have positive anti-HAV IgM within 30 days.
- Patients who were taking immunosuppressant or steroid.
- Patients who were allergic to HAV vaccine.
- Incompetent or unconsented patients.
Key Trial Info
Start Date :
September 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT03855176
Start Date
September 12 2017
End Date
December 30 2022
Last Update
January 26 2023
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan