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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention, China | OTHER_GOV |
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At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.
This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in HIV-Infected Patients
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. 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 |
|---|---|---|---|
| 20 µg at months 0, 1, and 6 | Experimental | 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
|
| 20 µg at months 0, 1, 2,and 6 | Experimental | 20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6 |
|
| 60 µg at months 0, 1, 2,and 6 | Experimental | 60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 | Biological | three-dose, 20 µg per dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs Seroconversion Rate at Month 7 | Anti-HBs Seroconversion Rate at month 7 as measured by CMIA | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs concentration at month 7 | Anti-HBs concentration at month 7 as measured by CMIA | Month 7 |
| Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suping Wang, PhD | Contact | #86-351-4135103 | spwang88@163.com | |
| Yongliang Feng, PhD | Contact | #86-351-4135362 | fengyongliang048@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Suping Wang, PhD | Shanxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanxi Center for Disease Control and Prevention | Taiyuan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35312441 | Derived | Feng Y, Chen Z, Xie R, Yao T, Wu Y, Yang F, Yuan C, Nie X, Wang F, Liang X, Wang S. Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2022 Jun;21(6):861-868. doi: 10.1080/14760584.2022.2056024. Epub 2022 Apr 1. |
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| 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 | Biological | four-dose, 20 µg per dose |
|
| 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 | Biological | four-dose, 60 µg per dose |
|
| Within 7 days after the vaccination |
| Anti-HBs Seroconversion Rate at month 12 | Anti-HBs Seroconversion Rate at month 12 as measured by CMIA | Month 12 |
| Anti-HBs concentration at month 12 | Anti-HBs concentration at month 12 as measured by CMIA | Month 12 |
| Anti-HBs Seroconversion Rate at month 18 | Anti-HBs Seroconversion Rate at month 18 as measured by CMIA | Month 18 |
| Anti-HBs concentration at month 18 | Anti-HBs concentration at month 18 as measured by CMIA | Month 18 |
| Anti-HBs Seroconversion Rate at month 30 | Anti-HBs Seroconversion Rate at month 30 as measured by CMIA | Month 30 |
| Anti-HBs concentration at month 30 | Anti-HBs concentration at month 30 as measured by CMIA | Month 30 |
| Anti-HBs Seroconversion Rate at month 42 | Anti-HBs Seroconversion Rate at month 42 as measured by CMIA | Month 42 |
| Anti-HBs concentration at month 42 | Anti-HBs concentration at month 42 as measured by CMIA | Month 42 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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