- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03962803
Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients
A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in HIV-Infected Patients
At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.
This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in HIV-Infected Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Suping Wang, PhD
- Phone Number: #86-351-4135103
- Email: spwang88@163.com
Study Contact Backup
- Name: Yongliang Feng, PhD
- Phone Number: #86-351-4135362
- Email: fengyongliang048@163.com
Study Locations
-
-
-
Taiyuan, China
- Shanxi Center for Disease Control and Prevention
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
- Sign informed consent, willing to participate in this study
Exclusion Criteria:
- Being pregnant
- Intolerance or allergy to any component of the vaccine
- Any vaccination during the month preceding enrollment
- CD4 cell count ≤ 200 cells/µL
- Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
- The use of immunosuppressive agents in patients with nearly three months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 20 µg at months 0, 1, and 6
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
|
three-dose, 20 µg per dose
|
Experimental: 20 µg at months 0, 1, 2,and 6
20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
|
four-dose, 20 µg per dose
|
Experimental: 60 µg at months 0, 1, 2,and 6
60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
|
four-dose, 60 µg per dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-HBs Seroconversion Rate at Month 7
Time Frame: Month 7
|
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
|
Month 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-HBs concentration at month 7
Time Frame: Month 7
|
Anti-HBs concentration at month 7 as measured by CMIA
|
Month 7
|
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
|
Within 7 days after the vaccination
|
Anti-HBs Seroconversion Rate at month 12
Time Frame: Month 12
|
Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
|
Month 12
|
Anti-HBs concentration at month 12
Time Frame: Month 12
|
Anti-HBs concentration at month 12 as measured by CMIA
|
Month 12
|
Anti-HBs Seroconversion Rate at month 18
Time Frame: Month 18
|
Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
|
Month 18
|
Anti-HBs concentration at month 18
Time Frame: Month 18
|
Anti-HBs concentration at month 18 as measured by CMIA
|
Month 18
|
Anti-HBs Seroconversion Rate at month 30
Time Frame: Month 30
|
Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
|
Month 30
|
Anti-HBs concentration at month 30
Time Frame: Month 30
|
Anti-HBs concentration at month 30 as measured by CMIA
|
Month 30
|
Anti-HBs Seroconversion Rate at month 42
Time Frame: Month 42
|
Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
|
Month 42
|
Anti-HBs concentration at month 42
Time Frame: Month 42
|
Anti-HBs concentration at month 42 as measured by CMIA
|
Month 42
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Suping Wang, PhD, Shanxi Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 2018ZX10721202001002001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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