Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in HIV-infected Adults in China

Conditions
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Hepatitis B Vaccine

Intervention / Treatment
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* Biological: 60 µg dose hepatitis B vaccine
* Biological: 20 µg dose hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 60 µg dose hepatitis B vaccine<br>60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 | Biological: 60 µg dose hepatitis B vaccine<br>* three-dose, 60 µg per dose<br>|
| Experimental: 20 µg dose hepatitis B vaccine<br>20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 | Biological: 20 µg dose hepatitis B vaccine<br>* three-dose, 20 µg per dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percentage of Participants With Anti-HBs Seroconversion at 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. | Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs Concentration at Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay ). | Month 7 | 
| Number and Percentage of Participants With Anti-HBs Seroconversion at 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. | Month 12 | 
| Anti-HBs Concentration at Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. | Month 12 | 
| Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine | Within 7 days after the vaccination | 
| Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine | Within 28 days after vaccination | 
| Serious Adverse Events (SAE) Occurred During 42 Month | Occurrence of Serious adverse events (SAE) within 42 month after vaccination with the hepatitis B | Month 0-42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Vaccine, Randomized Controlled Trial, HIV, Immunogenicity