Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

Hepatitis B Vaccine Clinical Trial

Official title:

Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963714
• Other study ID #: 2012ZX10002001003004001
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: July 2018

Study information

• Verified date: November 2021
• Source: Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge.

This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in hemodialysis patients.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: July 2018
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Having end-stage renal disease (ESRD) on maintenance hemodialysis

• Aged between 18 and 70 years at enrollment

• Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment

• Willing to adhere to the study protocol

Exclusion Criteria:

• Being pregnant

• Acute cytolysis in the last three months before enrollment

• Any vaccination during the month preceding enrollment

• Intolerance or allergy to any component of the vaccine

• Ongoing opportunistic infection

• Hepatitis C virus infection

• Hematological disorder

• Cancer

• Unexplained fever the week before enrollment

• Immunosuppressive or immunomodulating treatment in the last six months

• Renal transplantation or upcoming renal transplantation

• Liver disease

• Other immunocompromised condition not related to ESRD

• An expected survival of < 6 months

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccine

Intervention

Biological:
• 60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose
• 20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Suping Wang	Centers for Disease Control and Prevention, China

References & Publications (1)

Feng Y, Shi X, Shi J, Gao L, Liu G, Cheng Y, Pan M, Li C, Wang J, Guo X, Zhang Y, Liang X, Wang S. Immunogenicity, antibody persistence, and safety of the 60 µg hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, paralle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	High-level Response Rate at Month 7		Month 7
Other	High-level Response Rate at Month 12		Month 12
Other	High-level Response Rate at Month 18		Month 18
Other	High-level Response Rate at Month 30		Month 30
Other	High-level Response Rate at Month 36		Month 36
Other	High-level Response Rate at Month 42		Month 42
Other	High-level Response Rate at Month 24		Month 24
Primary	Anti-HBs Seroconversion Rate at Month 7		Month 7
Secondary	Anti-HBs Seroconversion Rate at Month 42		Month 42
Secondary	Anti-HBs Seroconversion Rate at Month 36		Month 36
Secondary	Anti-HBs Seroconversion Rate at Month 30		Month 30
Secondary	Anti-HBs Seroconversion Rate at Month 24		Month 24
Secondary	Anti-HBs Concentration at Month 7	Anti-HBs concentration at month 7 as measured by CMIA	Month 7
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 12		Month 12
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	Occurrence of Adverse Events After Vaccination	Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine	Within 28 days after the vaccination
Secondary	Anti-HBs Seroconversion Rate at Month 18		Month 18