Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

Suping Wang

Status and phase: Completed; Phase 4

Conditions: Hepatitis B Vaccine

Treatments: Biological: 20 µg dose hepatitis B vaccine; Biological: 60 µg dose hepatitis B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02963714

2012ZX10002001003004001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 352 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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352 participants in 2 patient groups

60 µg dose hepatitis B vaccine

Experimental group

Description:

60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6

Treatment:

Biological: 60 µg dose hepatitis B vaccine

20 µg dose hepatitis B vaccine

Experimental group

Description:

20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6

Treatment:

Biological: 20 µg dose hepatitis B vaccine