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出境医 / 临床实验 / Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population
Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population
Study Description
Brief Summary:
At present, chronic kidney disease population 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 chronic kidney disease population.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis B Vaccine | Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6 Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6 | Phase 4 |
Detailed Description:
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population |
| Estimated Study Start Date : | May 25, 2019 |
| Estimated Primary Completion Date : | February 2020 |
| Estimated Study Completion Date : | December 2023 |
Arms and Interventions
| 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
|
Biological: 20 µg recombinant hepatitis B vaccine 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
|
Biological: 20 µg recombinant hepatitis B vaccine 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
|
Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
four-dose, 60 µg per dose
|
Outcome Measures
Primary Outcome Measures :
- Anti-HBs Seroconversion Rate at Month 7 [ Time Frame: Month 7 ]Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
Secondary Outcome Measures :
- Anti-HBs concentration at month 7 [ Time Frame: Month 7 ]Anti-HBs concentration at month 7 as measured by CMIA
- 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
- Anti-HBs Seroconversion Rate at Month 12 [ Time Frame: Month 12 ]Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
- Anti-HBs Concentration at Month 12 [ Time Frame: Month 12 ]Anti-HBs Concentration at Month 12 as measured by CMIA
- Anti-HBs Seroconversion Rate at Month 18 [ Time Frame: Month 18 ]Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
- Anti-HBs Concentration at Month 18 [ Time Frame: Month 18 ]Anti-HBs Concentration at Month 18 as measured by CMIA
- Anti-HBs Seroconversion Rate at Month 30 [ Time Frame: Month 30 ]Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
- Anti-HBs Concentration at Month 30 [ Time Frame: Month 30 ]Anti-HBs Concentration at Month 30 as measured by CMIA
- Anti-HBs Seroconversion Rate at Month 42 [ Time Frame: Month 42 ]Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
- Anti-HBs Concentration at Month 42 [ Time Frame: Month 42 ]Anti-HBs Concentration at Month 42 as measured by CMIA
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Aged between 18 and 70 years at the enrolment
- 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
- Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
- Patients with Hepatitis B virus associated glomerulone nephritis or HBV DNA Positive
Contacts and Locations
Contacts
| Contact: Yongliang Feng, PhD | #86-351-4135362 | fengyongliang048@163.com | |
| Contact: Suping Wang, PhD | #86-351-4135103 | spwang88@163.com |
Locations
| China | |
| The Central Hospital of Linfen | |
| Linfen, China | |
| The People's Hospital of Linfen | |
| Linfen, China | |
Sponsors and Collaborators
Shanxi Medical University
Centers for Disease Control and Prevention, China
Investigators
| Principal Investigator: | Yongliang Feng, PhD | Shanxi Medical University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 23, 2019 | ||||||||
| First Posted Date ICMJE | May 24, 2019 | ||||||||
| Last Update Posted Date | May 24, 2019 | ||||||||
| Estimated Study Start Date ICMJE | May 25, 2019 | ||||||||
| Estimated Primary Completion Date | February 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Anti-HBs Seroconversion Rate at Month 7 [ Time Frame: Month 7 ] Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population | ||||||||
| Official Title ICMJE | Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population | ||||||||
| Brief Summary |
At present, chronic kidney disease population 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 chronic kidney disease population. |
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| Detailed Description | Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Hepatitis B Vaccine | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Feng Y, Yao T, Han Y, Shi J, Dong S, Wu Y, Shao Z, Liu H, Guo H, Chai G, Liu L, Wang F, Wang J, Liang X, Wang S. Immunogenicity and safety of a high-dose and prolonged-schedule hepatitis B vaccine among chronic kidney disease patients: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2021 May 31:1-9. doi: 10.1080/14760584.2021.1915777. [Epub ahead of print] | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
300 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 2023 | ||||||||
| Estimated Primary Completion Date | February 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03962881 | ||||||||
| Other Study ID Numbers ICMJE | 2018ZX10721202001003001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Suping Wang, Shanxi Medical University | ||||||||
| Study Sponsor ICMJE | Shanxi Medical University | ||||||||
| Collaborators ICMJE | Centers for Disease Control and Prevention, China | ||||||||
| Investigators ICMJE |
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| PRS Account | Shanxi Medical University | ||||||||
| Verification Date | May 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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