Status:
UNKNOWN
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
Conditions:
Viral Hepatitis B
Immunization; Infection
Eligibility:
MALE
20+ years
Phase:
PHASE4
Brief 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)...
Detailed Description
I. Study procedures: 1. Well explain, complete inform and consent documents 2. A blood test for hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs antibody), anti-hepati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
575 Patients enrolled
Trial Details
Trial ID
NCT03854630
Start Date
September 6 2017
End Date
December 31 2023
Last Update
May 22 2020
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100