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

Not Applicable

Completed

• Conditions: Hepatitis B; Hemodialysis Complication
• Interventions: Drug: Hepatitis B recombinant DNA vaccine; Drug: Combined hepatitis A and B vaccine

• Registration Number: NCT03149874
• Lead Sponsor: Benha University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-01
• Primary Completion: 2017-04-30
• Study Completion: 2017-05-01
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Hepatitis B recombinant DNA vaccine	Hepatitis B recombinant DNA vaccine	Each Hepatitis B recombinant DNA vaccine vial contained 20 microgram of vaccine dose. Two vials will be intramuscularly injected one vial in each deltoid muscle on months zero, one, two and six.
Combined hepatitis A and B vaccine	Combined hepatitis A and B vaccine	Each one-milliliter dose of vaccine contains 720 ELISA units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum. Two vials will be intramuscularly injected one vial in each deltoid muscle on on days zero, seven, and 21.

Primary Outcome Measures

Name	Time	Method
Hepatitis B virus Seroprotection after one month	one month after third dose of the vaccine	Hepatitis B virus surface antibodies titer after one month
Hepatitis B virus Seroprotection after three months	three months after third dose of the vaccine	Hepatitis B virus surface antibodies titer after three month

Secondary Outcome Measures

Name	Time	Method
Pain scale	1 Hour after each vaccination dose	Visual pain scale for pain from injection
Fever	4 Days after each vaccination dose	The proportion of fever among patients in both arms