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

NCT03962881 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-05-24

No results posted yet for this study

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.

Conditions

  • Hepatitis B Vaccine

Interventions

BIOLOGICAL

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

three-dose, 20 µg per dose

BIOLOGICAL

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

four-dose, 20 µg per dose

BIOLOGICAL

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

four-dose, 60 µg per dose

Sponsors & Collaborators

  • Centers for Disease Control and Prevention, China

    collaborator OTHER_GOV

  • Shanxi Medical University

    lead OTHER

Principal Investigators

  • Yongliang Feng, PhD · Shanxi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-25
Primary Completion
2020-02-29
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03962881 on ClinicalTrials.gov