Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis B Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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60 µg dose hepatitis B vaccine

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

Group Type EXPERIMENTAL

60 µg dose hepatitis B vaccine

Intervention Type BIOLOGICAL

three-dose, 60 µg per dose

20 µg dose hepatitis B vaccine

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

Group Type EXPERIMENTAL

20 µg dose hepatitis B vaccine

Intervention Type BIOLOGICAL

three-dose, 20 µg per dose

Interventions

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60 µg dose hepatitis B vaccine

three-dose, 60 µg per dose

Intervention Type BIOLOGICAL

20 µg dose hepatitis B vaccine

three-dose, 20 µg per dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No