Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults (HIV)

December 27, 2021 updated by: Suping Wang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 7 days after the vaccination
Anti-HBs Concentration at Month 7
Time Frame: 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
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.
Month 12
Anti-HBs Concentration at Month 12
Time Frame: Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
Month 12
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
Within 28 days after vaccination
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
Month 0-42

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 7
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.
Month 12
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.
Month 6 before the third injection
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）.
Month 6 before the third injection
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.
Month 6 before the third injection
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.
Month 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suping Wang

Collaborators

Centers for Disease Control and Prevention, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

December 27, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012ZX10002001003004004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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