Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention, China | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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 methadone maintenance treatment patients.
Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone Maintenance Treatment
Intervention:
Arm 1 : 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6;
Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml. | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs Concentration at Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | Month 7 |
| Anti-HBs Concentration at Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Rate of Participants With Anti-HBs High-level Response at Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response. | Month 7 |
| Number and Rate of Participants With Anti-HBs High-level Response at Month 12 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suping Wang | Shanxi Medical University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28343774 | Result | Shi J, Feng Y, Gao L, Feng D, Yao T, Shi S, Zhang Y, Liang X, Wang S. Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial. Vaccine. 2017 Apr 25;35(18):2443-2448. doi: 10.1016/j.vaccine.2017.03.034. Epub 2017 Mar 23. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
Not provided
Not provided
| 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 | Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml. | 73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7. | Posted | Count of Participants | Participants | Month 7 |
|
Not provided
Not provided
Not provided
| 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suping Wang, PhD | Shanxi Medical University | #86-351-4135103 | spwang88@163.com |
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 20 µg dose hepatitis B vaccine |
| Biological |
three-dose, 20 µg per dose |
|
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
| Month 12 |
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | 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, at Month 0, 1, and 6 |
| 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, at Month 0, 1, and 6 |
| Anti-HBs Concentration at Month 18 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | Month 18 |
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 18 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | Month 18 |
| Anti-HBs Concentration at Month 30 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | Month 30 |
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 30 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | Month 30 |
| Anti-HBs Concentration at Month 42 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | Month 42 |
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 42 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | Month 42 |
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response. |
| Month 12 |
| Number and Rate of Participants With Anti-HBs High-level Response at Month 18 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response. | Month 18 |
| Number and Rate of Participants With Anti-HBs High-level Response at Month 30 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response. | Month 30 |
| Number and Rate of Participants With Anti-HBs High-level Response at Month 42 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response. | Month 42 |
| 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 |
|
|
|
| Secondary | Anti-HBs Concentration at Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | 73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7 . | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 7 |
|
|
|
| Secondary | Anti-HBs Concentration at Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | 60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 12 |
|
|
|
| Secondary | Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | 60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Count of Participants | Participants | Month 12 |
|
|
|
| Secondary | Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine | 196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group. | Posted | Count of Participants | Participants | Within 7 days after the vaccination, at Month 0, 1, and 6 |
|
|
|
| Secondary | Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine | 196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group. | Posted | Count of Participants | Participants | Within 28 days after the vaccination, at Month 0, 1, and 6 |
|
|
|
| Other Pre-specified | Number and Rate of Participants With Anti-HBs High-level Response at Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response. | 73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7. | Posted | Count of Participants | Participants | Month 7 |
|
|
|
| Other Pre-specified | Number and Rate of Participants With Anti-HBs High-level Response at Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response. | 60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Count of Participants | Participants | Month 12 |
|
|
|
| Secondary | Anti-HBs Concentration at Month 18 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | 47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 18 |
|
|
|
| Secondary | Number and Rate of Participants With Anti-HBs Seroconversion at Month 18 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | 47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Count of Participants | Participants | Month 18 |
|
|
|
| Other Pre-specified | Number and Rate of Participants With Anti-HBs High-level Response at Month 18 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response. | 47 and 43 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Count of Participants | Participants | Month 18 |
|
|
|
| Secondary | Anti-HBs Concentration at Month 30 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | 46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 30 |
|
|
|
| Secondary | Number and Rate of Participants With Anti-HBs Seroconversion at Month 30 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | 46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Count of Participants | Participants | Month 30 |
|
|
|
| Secondary | Anti-HBs Concentration at Month 42 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | 45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 42 |
|
|
|
| Secondary | Number and Rate of Participants With Anti-HBs Seroconversion at Month 42 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | 45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Count of Participants | Participants | Month 42 |
|
|
|
| Other Pre-specified | Number and Rate of Participants With Anti-HBs High-level Response at Month 30 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response. | 46 and 42 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Count of Participants | Participants | Month 30 |
|
|
|
| Other Pre-specified | Number and Rate of Participants With Anti-HBs High-level Response at Month 42 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response. | 45 and 40 patients in the IM20 and IM60 groups completed the followed-up at months 12. | Posted | Count of Participants | Participants | Month 42 |
|
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| 7 |
| 98 |
| EG001 | IM 60μg Group | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | 0 | 97 | 0 | 97 | 8 | 97 |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |