Status:
COMPLETED
Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Lead Sponsor:
Suping Wang
Collaborating Sponsors:
Centers for Disease Control and Prevention, China
Conditions:
Hepatitis B Vaccine
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Uptake, adherence, and completion of vaccination among HIV-infected adults were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the ...
Detailed Description
Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group. The 20 µg group will receive three intramuscular injection...
Eligibility Criteria
Inclusion
- HIV-infected
- Aged between 18 and 70 years
- Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
- Willing to adhere to the study protocol
Exclusion
- Being pregnant
- Acute cytolysis in the last three months before enrollment
- Any vaccination before or during the month preceding enrollment
- Any Intolerance or allergy to any component of the vaccine
- Ongoing opportunistic infection
- Hematological disorder
- Cancer
- Unexplained fever the week before enrollment
- Immunosuppressive or immunomodulating treatment in the last six months
- Liver disease
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT03316807
Start Date
October 1 2014
End Date
July 1 2018
Last Update
March 11 2022
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