Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults

Hepatitis B Vaccine Clinical Trial

— HIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316807
• Other study ID #: 2012ZX10002001003004004
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: July 2018

Study information

• Verified date: December 2021
• Source: Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 2018
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccine

Intervention

Biological:
• 60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose
• 20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Suping Wang	Centers for Disease Control and Prevention, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number and Percentage of Participants With Anti-HBs High-level Response at Month 7	The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations =100 mIU/ml were high-level response.	Month 7
Other	Number and Percentage of Participants With Anti-HBs High-level Response at Month 12	The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations =100 mIU/ml were high-level response.	Month 12
Other	Number and Percentage of Participants With Anti-HBs Antibodies at 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.	Month 6 before the third injection
Other	Anti-HBs Concentration at Month 6 Before the Third Injection	Anti-HBs concentration at month 6 before the third injection as measured by CMIA(Chemiluminescent Microparticle Immunoassay).	Month 6 before the third injection
Other	Number and Percentage of Participants With Anti-HBs High-level Response at 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.	Month 6 before the third injection
Other	Number and Percentage of Participants With Anti-HBs Seroconversion at 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.	Month 42
Primary	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	Anti-HBs Concentration at Month 7	The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay ).	Month 7
Secondary	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
Secondary	Anti-HBs Concentration at Month 12	The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay).	Month 12
Secondary	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
Secondary	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
Secondary	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