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出境医 / 临床实验 / Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Study Description
Brief Summary:
At present, Methadone Maintenance Treatment 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 Methadone Maintenance Treatment Patients
| 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: | A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in Methadone Maintenance Treatment Patients |
| Estimated Study Start Date : | May 26, 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
- 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: | 20 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
- Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
- Patient with HIV Infection
- The use of immunosuppressive agents in patients with nearly three months
Contacts and Locations
Contacts
| Contact: Suping Wang, PhD | #86-351-4135103 | spwang88@163.com | |
| Contact: Yongliang Feng, PhD | #86-351-4135362 | fengyongliang048@163.com |
Locations
| China | |
| Xinghualing Methadone Drug Point | |
| Taiyuan, China | |
| Contact: Yongliang Feng, PhD #86-351-4135362 fengyongliang048@163.com | |
Sponsors and Collaborators
Shanxi Medical University
Centers for Disease Control and Prevention, China
Investigators
| Principal Investigator: | Suping Wang, 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 26, 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 | Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients | ||||||||
| Official Title ICMJE | A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in Methadone Maintenance Treatment Patients | ||||||||
| Brief Summary |
At present, Methadone Maintenance Treatment 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 Methadone Maintenance Treatment Patients |
||||||||
| 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 * | Not Provided | ||||||||
|
* 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 | 20 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 | NCT03962816 | ||||||||
| Other Study ID Numbers ICMJE | 2018ZX10721202001002002 | ||||||||
| 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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