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NCT03149874 Clinical Trial

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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03149874
Other study ID # BN-0517
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2014
Est. completion date May 1, 2017

Study information
Verified date February 2023
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date May 1, 2017
Est. primary completion date April 30, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Hepatitis B recombinant DNA vaccine
Hepatitis B recombinant DNA vaccine
• Combined hepatitis A and B vaccine
Combined hepatitis A and B vaccine given to the patients

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Benha University New Jeddah Clinic Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatitis B virus Seroprotection after one month Hepatitis B virus surface antibodies titer after one month one month after third dose of the vaccine
Primary Hepatitis B virus Seroprotection after three months Hepatitis B virus surface antibodies titer after three month three months after third dose of the vaccine
Secondary Fever The proportion of fever among patients in both arms 4 Days after each vaccination dose
Secondary Pain scale Visual pain scale for pain from injection 1 Hour after each vaccination dose
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