Overview

Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
Male
Summary
The primary aim of this open-label, randomized control trial is to compare the immunogenicity at week 28 after 20µg HBV vaccine (at week 0, 4, 24) versus 40µg HBV vaccine (40-µg at week 0, 4, 24 week) among HIV-positive patients or HIV-negative MSM who were born in Taiwan after July 1986 and tested negative for all HBV serological markers. The secondary aims are to assess the safety of double-dose HBV vaccination, the proportions of high-level responders (anti-HBs antibody >100 mIU/ml) at weeks 28 and 48, the serological responses at week 48, and incident HBV infection (indicated by appearance of anti-HBc and/or HBsAg) at week 48.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Taiwan University Hospital
Collaborator:
Taipei Veterans General Hospital, Taiwan
Criteria
Inclusion Criteria:

- Men who have sex with men (MSM)

- Birth date after 1986/7/1 and aged 20 years or older

- Seronegative for HBsAg, anti-HBs (<10 mIU/ml), and anti-HBc at screening (within 1
month of the first dose)

- Regularly receiving HIV care for HIV-positive patients over the past 6 months

- Seeking VCT for at least once for HIV-negative patients over the past 12 months

Exclusion Criteria:

- Active infection or malignancy within 12 months of screening

- Receiving chemotherapy, immunosuppressant, or IVIG within 12 months of screening

- Received higher than 5 mg of prednisolone, including IV, oral, or topical form, per
day for more than 1 weeks within 6 months of screening

- Receiving HBV vaccination within 1 months of screening, or being allergic to HBV
vaccine

- Receiving other vaccination within 1 months of screening, such as influenza,
pneumococcus, HPV, HAV, varicella vaccine.

- Stage 4 and 5 of chronic kidney disease (GFR<30 mL/min/1.73m), or receiving dialysis.