MedTrace Logo

Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

NCT02963714 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2022-02-14

Study results available
· View outcomes & findings →

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.

Conditions

  • Hepatitis B Vaccine

Interventions

BIOLOGICAL

60 µg dose hepatitis B vaccine

three-dose, 60 µg per dose

BIOLOGICAL

20 µg dose hepatitis B vaccine

three-dose, 20 µg per dose

Sponsors & Collaborators

  • Centers for Disease Control and Prevention, China

    collaborator OTHER_GOV

  • Suping Wang

    lead OTHER

Principal Investigators

  • Suping Wang · 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
2014-12-31
Primary Completion
2015-07-31
Completion
2018-07-31

More Related Trials

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 NCT02963714 on ClinicalTrials.gov