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:
Participant gender:
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.