60 µg dose hepatitis B vaccine
Biologicalthree-dose, 60 µg per dose
Completed
NCT Number: NCT03316807
Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
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.
Completed
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Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
20 µg dose hepatitis B vaccine
Biologicalthree-dose, 20 µg per dose
Primary outcomes
-
Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7
Time frame: 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 outcomes
-
Anti-HBs Concentration at Month 7
Time frame: Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay ).
-
Number and Percentage of Participants With Anti-HBs Seroconversion at Month 12
Time frame: 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.
-
Anti-HBs Concentration at Month 12
Time frame: Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
-
Occurrence of Adverse Events After Vaccination
Time frame: Within 7 days after the vaccination
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
-
Occurrence of Adverse Events After Vaccination
Time frame: Within 28 days after vaccination
Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
-
Serious Adverse Events (SAE) Occurred During 42 Month
Time frame: Month 0-42
Occurrence of Serious adverse events (SAE) within 42 month after vaccination with the hepatitis B
Other outcomes
-
Number and Percentage of Participants With Anti-HBs High-level Response at Month 7
Time frame: Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
-
Number and Percentage of Participants With Anti-HBs High-level Response at Month 12
Time frame: Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
-
Number and Percentage of Participants With Anti-HBs Antibodies at Month 6 Before the Third Injection
Time frame: Month 6 before the third injection
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
-
Anti-HBs Concentration at Month 6 Before the Third Injection
Time frame: Month 6 before the third injection
Anti-HBs concentration at month 6 before the third injection as measured by CMIA（Chemiluminescent Microparticle Immunoassay）.
-
Number and Percentage of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection
Time frame: Month 6 before the third injection
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
-
Number and Percentage of Participants With Anti-HBs Seroconversion at Month 42
Time frame: Month 42
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.
Sponsors and collaborators
Lead sponsor
Suping Wang
Other
Collaborators
- Centers for Disease Control and Prevention, China
Registry information
Official study title
Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in HIV-infected Adults in China
Acronym: HIV
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2018
- First posted
- Oct 20, 2017
- Registry last updated
- Mar 11, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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