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?

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Hemodialysis Complication
• Intervention / Treatment: Drug: Hepatitis B recombinant DNA vaccine; Drug: Combined hepatitis A and B vaccine

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: Hepatitis B recombinant DNA vaccine; Hepatitis B recombinant DNA vaccine
ACTIVE_COMPARATOR: 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.	Drug: Combined hepatitis A and B vaccine; Combined hepatitis A and B vaccine given to the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatitis B virus Seroprotection after one month	Hepatitis B virus surface antibodies titer after one month	one month after third dose of the vaccine
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Benha University
• Collaborators: New Jeddah Clinic Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2014
• Primary Completion (ACTUAL): April 30, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (ACTUAL): May 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BN-0517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No