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| Name | Class |
|---|---|
| Guangxi Center for Disease Control and Prevention | OTHER_GOV |
| Liuzhou City Center for disease control and prevention | UNKNOWN |
| Shenzhen Kangtai Biological Products Co., LTD | INDUSTRY |
The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20μg, 0-1-6 | Active Comparator | 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule. |
|
| 60μg, 0-1 | Experimental | 112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule. |
|
| 60μg, 0-2 | Experimental | 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis B vaccine | Biological | Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults | The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. | one month after a series vaccination of the regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults | The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs will be compared among the three vaccine groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of HBV Vaccine Determined by Number of Participants With Adverse Events | Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhongliao Fang, Dr. | Guangxi provincial center for desease control and prevention | Study Director |
| Hui Zhuang, Dr. | Peking University Health Science Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University | Beijing | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26801063 | Derived | Wang ZZ, Li MQ, Wang P, Yang ZX, Wei L, Zeng Y, Li YP, Yan L, Liu XE, Zhuang H. Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China. Vaccine. 2016 Feb 17;34(8):1034-9. doi: 10.1016/j.vaccine.2016.01.018. Epub 2016 Jan 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 20μg, 0-1-6 | 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule. |
| FG001 | 60μg, 0-1 | 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule. |
| FG002 | 60μg, 0-2 | 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 20μg, 0-1-6 | 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule. |
| BG001 | 60μg, 0-1 | 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule. |
| 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 | Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults | The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. | Posted | Geometric Mean | 95% Confidence Interval | mIU/ml | one month after a series vaccination of the regimen |
|
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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 | 20μg, 0-1-6 | 117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| injection site pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hui Zhuang | Peking University Health Science Center | 86-10-82801617 | zhuangbmu@126.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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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| 1-year after the first dose of the regimens |
| Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults | The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years. | 2-year after the first dose of the regimens |
| 0-3 day after the first dose of immunization |
| BG002 | 60μg, 0-2 | 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 60μg, 0-1 |
111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule. |
| OG002 | 60μg, 0-2 | 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule. |
|
|
|
| Secondary | Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults | The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs will be compared among the three vaccine groups. | Posted | Geometric Mean | 95% Confidence Interval | mIU/ml | 1-year after the first dose of the regimens |
|
|
|
| Secondary | Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults | The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years. | Posted | Geometric Mean | 95% Confidence Interval | mIU/ml | 2-year after the first dose of the regimens |
|
|
|
| Other Pre-specified | Safety of HBV Vaccine Determined by Number of Participants With Adverse Events | Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3. | Posted | Number | number of participants | 0-3 day after the first dose of immunization |
|
|
|
| 0 |
| 117 |
| 2 |
| 117 |
| EG001 | 60μg, 0-1 | 111 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule. | 0 | 111 | 2 | 111 |
| EG002 | 60μg, 0-2 | 125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule. | 0 | 125 | 5 | 125 |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |