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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 HIV-infected adults 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 HIV-infected adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination remains a challenge.
This is a randomized, open-label trial, conducted among HIV-infected adults with drug rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among HIV-infected adults.
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 |
|---|---|---|
| Number and Percentage 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 |
| Number and Percentage of Participants With Anti-HBs Seroconversion at Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage 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 Percentage 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 |
|---|---|---|---|
| 34052065 | Derived | Feng Y, Yao T, Chang Y, Gao L, Shao Z, Dong S, Wu Y, Shi X, Shi J, Feng D, Cheng Y, Pan M, Li C, Wang J, Lan G, Lu H, Wang P, Xiang S, Nong L, Wang F, Liang X, Wang S. Immunogenicity and persistence of high-dose recombinant hepatitis B vaccine in adults infected with human immunodeficiency virus in China: A randomized, double-blind, parallel controlled trial. Vaccine. 2021 Jun 16;39(27):3582-3589. doi: 10.1016/j.vaccine.2021.05.044. Epub 2021 May 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 60 µg Dose Hepatitis B Vaccine | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose |
| FG001 | 20 µg Dose Hepatitis B Vaccine | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 60 µg Dose Hepatitis B Vaccine | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose |
| BG001 | 20 µg Dose Hepatitis B Vaccine |
| 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 Percentage 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. | 83 and 82 patients in the IM60（60μg recombinant hepatitis B vaccine） and IM20（20μg recombinant hepatitis B vaccine） groups completed the followed-up at months 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 | 60 µg Dose Hepatitis B Vaccine | 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 60 µg dose hepatitis B vaccine: three-dose, 60 µg per dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | Non-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 |
|
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 |
| Anti-HBs Concentration at Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. | 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 vaccination |
| Serious Adverse Events (SAE) Occurred During 42 Month | Occurrence of Serious adverse events (SAE) within 42 month after vaccination with the hepatitis B | Month 0-42 |
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 Percentage of Participants With Anti-HBs Antibodies 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 |
| Anti-HBs Concentration at Month 6 Before the Third Injection | Anti-HBs concentration at month 6 before the third injection as measured by CMIA（Chemiluminescent Microparticle Immunoassay）. | Month 6 before the third injection |
| Number and Percentage 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 |
| Number and Percentage 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 |
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose |
|
|
| 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 | Number and Percentage 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. | Posted | Count of Participants | Participants | Month 12 |
|
|
|
| Secondary | Anti-HBs Concentration at Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. | Posted | Mean | 95% Confidence Interval | mIU/ml | Month 12 |
|
|
|
| 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 | Safety analysis was performed on all included participants. | Posted | Number | participants | Within 28 days after vaccination |
|
|
|
| Secondary | Serious Adverse Events (SAE) Occurred During 42 Month | Occurrence of Serious adverse events (SAE) within 42 month after vaccination with the hepatitis B | Posted | Count of Participants | Participants | Month 0-42 |
|
|
|
| Other Pre-specified | Number and Percentage 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 Percentage 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 | Number and Percentage of Participants With Anti-HBs Antibodies 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. | 83 and 70 patients in the IM60 and IM20 groups completed the followed-up at month 6 before the third injection. | Posted | Count of Participants | Participants | Month 6 before the third injection |
|
|
|
| Other Pre-specified | Anti-HBs Concentration at Month 6 Before the Third Injection | Anti-HBs concentration at month 6 before the third injection as measured by CMIA（Chemiluminescent Microparticle Immunoassay）. | Posted | Mean | 95% Confidence Interval | mIU/ml | Month 6 before the third injection |
|
|
|
| Other Pre-specified | Number and Percentage 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 |
|
|
|
| Other Pre-specified | Number and Percentage 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. | Posted | Count of Participants | Participants | Month 42 |
|
|
|
| 0 |
| 88 |
| 0 |
| 88 |
| 8 |
| 88 |
| EG001 | 20 µg Dose Hepatitis B Vaccine | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 20 µg dose hepatitis B vaccine: three-dose, 20 µg per dose | 0 | 88 | 0 | 88 | 6 | 88 |
| erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| induration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| edema |
|
| induration |
|