Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients
- Conditions
- Hepatitis B Vaccine
- Registration Number
- NCT03962803
- Lead Sponsor
- Shanxi Medical University
- Brief Summary
At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.
This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in HIV-Infected Patients
- Detailed Description
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
- Sign informed consent, willing to participate in this study
- Being pregnant
- Intolerance or allergy to any component of the vaccine
- Any vaccination during the month preceding enrollment
- CD4 cell count ≤ 200 cells/µL
- Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
- The use of immunosuppressive agents in patients with nearly three months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-HBs Seroconversion Rate at Month 7 Month 7 Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
- Secondary Outcome Measures
Name Time Method Anti-HBs concentration at month 7 Month 7 Anti-HBs concentration at month 7 as measured by CMIA
Anti-HBs concentration at month 30 Month 30 Anti-HBs concentration at month 30 as measured by CMIA
Occurrence of Adverse Events After Vaccination Within 7 days after the vaccination Occurrence of adverse reactions within 7 days after vaccination with the hepatitis
Anti-HBs Seroconversion Rate at month 42 Month 42 Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
Anti-HBs Seroconversion Rate at month 12 Month 12 Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
Anti-HBs Seroconversion Rate at month 18 Month 18 Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
Anti-HBs concentration at month 42 Month 42 Anti-HBs concentration at month 42 as measured by CMIA
Anti-HBs concentration at month 12 Month 12 Anti-HBs concentration at month 12 as measured by CMIA
Anti-HBs concentration at month 18 Month 18 Anti-HBs concentration at month 18 as measured by CMIA
Anti-HBs Seroconversion Rate at month 30 Month 30 Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
Trial Locations
- Locations (1)
Shanxi Center for Disease Control and Prevention
🇨🇳Taiyuan, China
Shanxi Center for Disease Control and Prevention🇨🇳Taiyuan, China