Hepatitis B Vaccine
Conditions
Keywords
Hepatitis B Vaccine, Randomized Controlled Trial, Chronic Kidney Disease Population, Immunogenicity, Long-term Immune Response
Brief summary
At present, chronic kidney disease population 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 chronic kidney disease population.
Detailed description
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.
Interventions
three-dose, 20 µg per dose
BIOLOGICAL20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
four-dose, 20 µg per dose
BIOLOGICAL60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
four-dose, 60 µg per dose
Sponsors
Centers for Disease Control and Prevention, China
Shanxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 70 years at the enrolment * Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment * Sign informed consent, willing to participate in this study
Exclusion criteria
* Being pregnant * Intolerance or allergy to any component of the vaccine * Any vaccination during the month preceding enrollment * Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever * Patients with Hepatitis B virus associated glomerulone nephritis or HBV DNA Positive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-HBs Seroconversion Rate at Month 7 | Month 7 | Anti-HBs Seroconversion Rate at month 7 as measured by CMIA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events After Vaccination | Within 7 days after the vaccination | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine |
| Anti-HBs Seroconversion Rate at Month 12 | Month 12 | Anti-HBs Seroconversion Rate at month 12 as measured by CMIA |
| Anti-HBs Concentration at Month 12 | Month 12 | Anti-HBs Concentration at Month 12 as measured by CMIA |
| Anti-HBs Seroconversion Rate at Month 18 | Month 18 | Anti-HBs Seroconversion Rate at month 18 as measured by CMIA |
| Anti-HBs concentration at month 7 | Month 7 | Anti-HBs concentration at month 7 as measured by CMIA |
| Anti-HBs Seroconversion Rate at Month 30 | Month 30 | Anti-HBs Seroconversion Rate at month 30 as measured by CMIA |
| Anti-HBs Concentration at Month 30 | Month 30 | Anti-HBs Concentration at Month 30 as measured by CMIA |
| Anti-HBs Seroconversion Rate at Month 42 | Month 42 | Anti-HBs Seroconversion Rate at month 42 as measured by CMIA |
| Anti-HBs Concentration at Month 42 | Month 42 | Anti-HBs Concentration at Month 42 as measured by CMIA |
| Anti-HBs Concentration at Month 18 | Month 18 | Anti-HBs Concentration at Month 18 as measured by CMIA |
Countries
China
Contacts
Primary ContactYongliang Feng, PhD
Backup ContactSuping Wang, PhD
Outcome results
None listed