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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention, China | OTHER_GOV |
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Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge.
This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in hemodialysis patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 µg dose hepatitis B vaccine | Experimental | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
|
| 20 µg dose hepatitis B vaccine | Experimental | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 60 µg dose hepatitis B vaccine | Biological | three-dose, 60 µg per dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs Seroconversion Rate at Month 7 | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs Seroconversion Rate at Month 42 | Month 42 | |
| Anti-HBs Seroconversion Rate at Month 36 | Month 36 | |
| Anti-HBs Seroconversion Rate at Month 30 |
| Measure | Description | Time Frame |
|---|---|---|
| High-level Response Rate at Month 7 | Month 7 | |
| High-level Response Rate at Month 12 | Month 12 | |
| High-level Response Rate at Month 18 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suping Wang | Shanxi Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28803502 | Result | Feng Y, Shi X, Shi J, Gao L, Liu G, Cheng Y, Pan M, Li C, Wang J, Guo X, Zhang Y, Liang X, Wang S. Immunogenicity, antibody persistence, and safety of the 60 mug hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial. Expert Rev Vaccines. 2017 Oct;16(10):1045-1052. doi: 10.1080/14760584.2017.1367667. Epub 2017 Aug 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IM 20μg Group | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
| FG001 | IM 60μg Group | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IM 20μg Group | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
| BG001 | IM 60μg Group | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anti-HBs Seroconversion Rate at Month 7 | Posted | Count of Participants | Participants | Month 7 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IM 20μg Group | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suping Wang, PhD | Shanxi Medical University | #86-351-4135103 | spwang88@163.com |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| 20 µg dose hepatitis B vaccine |
| Biological |
three-dose, 20 µg per dose |
|
| Month 30 |
| Anti-HBs Seroconversion Rate at Month 24 | Month 24 |
| Anti-HBs Concentration at Month 7 | Anti-HBs concentration at month 7 as measured by CMIA | Month 7 |
| Anti-HBs Concentration at Month 12 | Anti-HBs concentration at month 12 as measured by CMIA | Month 12 |
| Anti-HBs Seroconversion Rate at Month 12 | Month 12 |
| Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine | Within 7 days after the vaccination |
| Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine | Within 28 days after the vaccination |
| Anti-HBs Seroconversion Rate at Month 18 | Month 18 |
| Month 18 |
| High-level Response Rate at Month 30 | Month 30 |
| High-level Response Rate at Month 36 | Month 36 |
| High-level Response Rate at Month 42 | Month 42 |
| High-level Response Rate at Month 24 | Month 24 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
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| Secondary | Anti-HBs Seroconversion Rate at Month 42 | Posted | Count of Participants | Participants | Month 42 |
|
|
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| Secondary | Anti-HBs Seroconversion Rate at Month 36 | Posted | Count of Participants | Participants | Month 36 |
|
|
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| Secondary | Anti-HBs Seroconversion Rate at Month 30 | Posted | Count of Participants | Participants | Month 30 |
|
|
|
| Secondary | Anti-HBs Seroconversion Rate at Month 24 | Posted | Count of Participants | Participants | Month 24 |
|
|
|
| Secondary | Anti-HBs Concentration at Month 7 | Anti-HBs concentration at month 7 as measured by CMIA | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 7 |
|
|
|
| Secondary | Anti-HBs Concentration at Month 12 | Anti-HBs concentration at month 12 as measured by CMIA | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 12 |
|
|
|
| Secondary | Anti-HBs Seroconversion Rate at Month 12 | Posted | Count of Participants | Participants | Month 12 |
|
|
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| Secondary | Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine | Posted | Count of Participants | Participants | Within 7 days after the vaccination |
|
|
|
| Secondary | Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine | Posted | Count of Participants | Participants | Within 28 days after the vaccination |
|
|
|
| Secondary | Anti-HBs Seroconversion Rate at Month 18 | Posted | Count of Participants | Participants | Month 18 |
|
|
|
| Other Pre-specified | High-level Response Rate at Month 7 | Posted | Count of Participants | Participants | Month 7 |
|
|
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| Other Pre-specified | High-level Response Rate at Month 12 | Posted | Count of Participants | Participants | Month 12 |
|
|
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| Other Pre-specified | High-level Response Rate at Month 18 | Posted | Count of Participants | Participants | Month 18 |
|
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| Other Pre-specified | High-level Response Rate at Month 30 | Posted | Count of Participants | Participants | Month 30 |
|
|
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| Other Pre-specified | High-level Response Rate at Month 36 | Posted | Count of Participants | Participants | Month 36 |
|
|
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| Other Pre-specified | High-level Response Rate at Month 42 | Posted | Count of Participants | Participants | Month 42 |
|
|
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| Other Pre-specified | High-level Response Rate at Month 24 | Posted | Count of Participants | Participants | Month 24 |
|
|
|
| 0 |
| 174 |
| 0 |
| 174 |
| 8 |
| 174 |
| EG001 | IM 60μg Group | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | 0 | 175 | 0 | 175 | 8 | 175 |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |