Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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) have a higher risk of acquiring HAV due to their behaviors. Reemerging threat of hepatitis A among MSM in Taiwan has been reported recently. Based on the guidelines for the diagnosis and treatment of HIV/AIDS and the Advisory Committee on Immunization Practices (ACIP), Taiwan, vaccination of individuals against HAV with any of the following indications is recommended: HIV patients, adults with chronic hepatic disease, hemophilia, liver transplantation, occupational exposure, MSM, persons who use injection or noninjection illicit drugs, or persons traveling to or working in countries that have endemicity of HAV.

In HIV-infected patients, the immunogenicity to HAV vaccination is sub-optimal in HIV-infected patients and the seroconversion rate is estimated 68-90% after administration of 2 or 3 doses of HAV vaccine. Furthermore, the antibody titers of HIV-infected patients following HAV vaccination are significantly lower compared to those of HIV-uninfected persons. The sub-optimal response among HIV-infected subjects remains an unresolved problem. In this study, the investigators aim to determine the to conduct a randomized clinical trial to compare the immunogenicity of 2 different doses of HAV vaccination (1 dose versus 2 doses) in HIV-infected patients who failed to achieve serologic response in the primary vaccination. This proposal will provide the solid evidence to elucidate the role of booster HAV vaccination in HIV-infected patients without response to primary HAV vaccination.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.