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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-25

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

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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20 µg at months 0, 1, and 6

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

three-dose, 20 µg per dose

20 µg at months 0, 1, 2,and 6

20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6

Group Type EXPERIMENTAL

20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6

Intervention Type BIOLOGICAL

four-dose, 20 µg per dose

60 µg at months 0, 1, 2,and 6

60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6

Group Type EXPERIMENTAL

60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6

Intervention Type BIOLOGICAL

four-dose, 60 µg per dose

Interventions

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

three-dose, 20 µg per dose

Intervention Type BIOLOGICAL

20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6

four-dose, 20 µg per dose

Intervention Type BIOLOGICAL

60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6

four-dose, 60 µg per dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No