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Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients

Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients, Does it Works?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03149874
Enrollment
114
Registered
2017-05-11
Start date
2014-12-01
Completion date
2017-05-01
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Complication, Hepatitis B

Brief summary

The aim of this study is to examine the result of seroprotection using the accelerated vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis A and B vaccine.

Interventions

DRUGHepatitis B recombinant DNA vaccine

Hepatitis B recombinant DNA vaccine

Combined hepatitis A and B vaccine given to the patients

Sponsors

New Jeddah Clinic Hospital
CollaboratorINDUSTRY
Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Patient seuentially randomized to either vaccine

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age was above 18 years * Hemodialysis patient * All patients had undetectable hepatitis B virus surface antigen and antibody

Exclusion criteria

* A positive serum hepatitis B virus surface antigen and antibody * patient received a previous course of hepatitis B virus vaccine

Design outcomes

Primary

MeasureTime frameDescription
Hepatitis B virus Seroprotection after one monthone month after third dose of the vaccineHepatitis B virus surface antibodies titer after one month
Hepatitis B virus Seroprotection after three monthsthree months after third dose of the vaccineHepatitis B virus surface antibodies titer after three month

Secondary

MeasureTime frameDescription
Fever4 Days after each vaccination doseThe proportion of fever among patients in both arms
Pain scale1 Hour after each vaccination doseVisual pain scale for pain from injection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026