Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population

Hepatitis B Vaccine Clinical Trial

Official title:

Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03962881
• Other study ID #: 2018ZX10721202001003001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 25, 2019
• Est. completion date: December 2023

Study information

• Verified date: May 2019
• Source: Shanxi Medical University
• Contact: Yongliang Feng, PhD
• Phone: #86-351-4135362
• Email: fengyongliang048[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccine
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
three-dose, 20 µg per dose
• 20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
four-dose, 20 µg per dose
• 60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
four-dose, 60 µg per dose

Locations

Country	Name	City	State
China	The Central Hospital of Linfen	Linfen
China	The People's Hospital of Linfen	Linfen

Sponsors (2)

Lead Sponsor	Collaborator
Shanxi Medical University	Centers for Disease Control and Prevention, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs Seroconversion Rate at Month 7	Anti-HBs Seroconversion Rate at month 7 as measured by CMIA	Month 7
Secondary	Anti-HBs concentration at month 7	Anti-HBs concentration at month 7 as measured by CMIA	Month 7
Secondary	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
Secondary	Anti-HBs Seroconversion Rate at Month 12	Anti-HBs Seroconversion Rate at month 12 as measured by CMIA	Month 12
Secondary	Anti-HBs Concentration at Month 12	Anti-HBs Concentration at Month 12 as measured by CMIA	Month 12
Secondary	Anti-HBs Seroconversion Rate at Month 18	Anti-HBs Seroconversion Rate at month 18 as measured by CMIA	Month 18
Secondary	Anti-HBs Concentration at Month 18	Anti-HBs Concentration at Month 18 as measured by CMIA	Month 18
Secondary	Anti-HBs Seroconversion Rate at Month 30	Anti-HBs Seroconversion Rate at month 30 as measured by CMIA	Month 30
Secondary	Anti-HBs Concentration at Month 30	Anti-HBs Concentration at Month 30 as measured by CMIA	Month 30
Secondary	Anti-HBs Seroconversion Rate at Month 42	Anti-HBs Seroconversion Rate at month 42 as measured by CMIA	Month 42
Secondary	Anti-HBs Concentration at Month 42	Anti-HBs Concentration at Month 42 as measured by CMIA	Month 42