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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention, China | OTHER_GOV |
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Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection.
This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users
Comparison of 2 vaccination strategy against Hepatitis B in Drug Users
Intervention:
Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6;
Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6;
Arm 3 : Receive no vaccination during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 µg dose hepatitis B vaccine | Experimental | Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6 |
|
| 20 µg dose hepatitis B vaccine | Experimental | Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6 |
|
| Control | No Intervention | Receive no vaccination during the study period |
| 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:
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| Name | Affiliation | Role |
|---|---|---|
| Suping Wang | Shanxi Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28301282 | Result | Feng Y, Shi J, Gao L, Yao T, Feng D, Luo D, Li Z, Zhang Y, Wang F, Cui F, Li L, Liang X, Wang S. Immunogenicity and safety of high-dose hepatitis B vaccine among drug users: A randomized, open-labeled, blank-controlled trial. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-7. doi: 10.1080/21645515.2017.1283082. Epub 2017 Mar 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IM20 Group | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
| FG001 | IM60 Group | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
| FG002 | Blank Control Group | Participants received no intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IM20 Group | Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6. |
| BG001 | IM60 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. | Exclusion of participants who did not received/competed vaccine or left the centers.150, 149 and 151 patients in the IM20, IM60 and blank control groups completed the followed-up at months 7 . | Posted | Count of Participants | Participants | Month 7 |
|
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The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
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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 | IM20 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 |
|---|---|---|---|---|---|
| erytherma | Skin and subcutaneous 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 |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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 | 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 | Within 28 days after the vaccination, at Month 0, 1, and 6 |
| Serious Adverse Events (SAE) Occurred During Month 12 | Month 0-12 |
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response. |
| Month 12 |
| Anti-HBs Concentration at Month 6 Before the Third Injection | Anti-HBs concentration at month 6 before the third injection by CMIA | Month 6 before the third injection |
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. The accepted protective serum anti-HBs level was ≥10 mIU/ml. | Month 6 before the third injection |
| Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response. | Month 6 before the third injection |
| BG002 | Blank Control Group | Participants received no intervention. |
| BG003 | 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 |
|
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
| OG002 | Blank Control Group | Participants received no intervention |
|
|
| Secondary | Anti-HBs Concentration at Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. | 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）. | 133, 133 and 124 patients in the IM20, IM60 and blank control 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. | 133, 133 and 124 patients in the IM20, IM60 and blank control 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 | 158 participants in the IM20 group and 156 in the IM60 group received the first injection. The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed. | 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 | The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed. | Posted | Count of Participants | Participants | Within 28 days after the vaccination, at Month 0, 1, and 6 |
|
|
|
| Secondary | Serious Adverse Events (SAE) Occurred During Month 12 | The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed. | Posted | Count of Participants | Participants | Month 0-12 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Month 12 |
|
|
|
| Other Pre-specified | Anti-HBs Concentration at Month 6 Before the Third Injection | Anti-HBs concentration at month 6 before the third injection by CMIA | 155 and 150 patients in the IM20 and IM60 groups completed the followed-up at months 6 before the third injection. | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 6 before the third injection |
|
|
|
| Other Pre-specified | Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. The accepted protective serum anti-HBs level was ≥10 mIU/ml. | Posted | Count of Participants | Participants | Month 6 before the third injection |
|
|
|
| Other Pre-specified | Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection | The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response. | Posted | Count of Participants | Participants | Month 6 before the third injection |
|
|
|
| 0 |
| 158 |
| 0 |
| 158 |
| 12 |
| 158 |
| EG001 | IM60 Group | Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6. | 0 | 156 | 0 | 156 | 11 | 156 |
| pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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