Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
HIV
Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in HIV-infected Adults in China
1 other identifier
interventional
182
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2014
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 17, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedResults Posted
Study results publicly available
January 14, 2021
CompletedMarch 11, 2022
December 1, 2021
9 months
October 17, 2017
December 20, 2020
December 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Anti-HBs Concentration at Month 7
Month 7
Number and Percentage of Participants With Anti-HBs Seroconversion at Month 12
Month 12
Anti-HBs Concentration at Month 12
Month 12
Occurrence of Adverse Events After Vaccination
Within 7 days after the vaccination
Occurrence of Adverse Events After Vaccination
Within 28 days after vaccination
- +1 more secondary outcomes
Other Outcomes (6)
Number and Percentage of Participants With Anti-HBs High-level Response at Month 7
Month 7
Number and Percentage of Participants With Anti-HBs High-level Response at Month 12
Month 12
Number and Percentage of Participants With Anti-HBs Antibodies at Month 6 Before the Third Injection
Month 6 before the third injection
- +3 more other outcomes
Study Arms (2)
60 µg dose hepatitis B vaccine
EXPERIMENTAL60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
20 µg dose hepatitis B vaccine
EXPERIMENTAL20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Suping Wanglead
- Centers for Disease Control and Prevention, Chinacollaborator
Related Publications (1)
Feng Y, Yao T, Chang Y, Gao L, Shao Z, Dong S, Wu Y, Shi X, Shi J, Feng D, Cheng Y, Pan M, Li C, Wang J, Lan G, Lu H, Wang P, Xiang S, Nong L, Wang F, Liang X, Wang S. Immunogenicity and persistence of high-dose recombinant hepatitis B vaccine in adults infected with human immunodeficiency virus in China: A randomized, double-blind, parallel controlled trial. Vaccine. 2021 Jun 16;39(27):3582-3589. doi: 10.1016/j.vaccine.2021.05.044. Epub 2021 May 26.
PMID: 34052065DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Suping Wang, PhD
- Organization
- Shanxi Medical University
Study Officials
- PRINCIPAL INVESTIGATOR
Suping Wang
Shanxi Medical University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 17, 2017
First Posted
October 20, 2017
Study Start
October 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2018
Last Updated
March 11, 2022
Results First Posted
January 14, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share