Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
- Conditions
- Hepatitis B Vaccine
- Interventions
- Biological: 60 µg dose hepatitis B vaccineBiological: 20 µg dose hepatitis B vaccine
- Registration Number
- NCT03316807
- Lead Sponsor
- Suping Wang
- 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 current practice of hepatitis B vaccination can't protect HIV-infected adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination remains a challenge.
This is a randomized, open-label trial, conducted among HIV-infected adults with drug rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among HIV-infected adults.
- 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 injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 60 µg dose hepatitis B vaccine 60 µg dose hepatitis B vaccine 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine 20 µg dose hepatitis B vaccine 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
- Primary Outcome Measures
Name Time Method Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7 Month 7 The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay ). The accepted protective serum anti-HBs level was ≥10 mIU/ml.
- Secondary Outcome Measures
Name Time Method Anti-HBs Concentration at Month 12 Month 12 The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
Anti-HBs Concentration at Month 7 Month 7 The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay ).
Serious Adverse Events (SAE) Occurred During 42 Month Month 0-42 Occurrence of Serious adverse events (SAE) within 42 month after vaccination with the hepatitis B
Number and Percentage of Participants With Anti-HBs Seroconversion at Month 12 Month 12 The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Occurrence of Adverse Events After Vaccination Within 28 days after vaccination Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine