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

NCT ID: NCT03149874

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-01

Study Completion Date

2017-05-01

Brief Summary

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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

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Conditions

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Hepatitis B Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Patient seuentially randomized to either vaccine
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Hepatitis B recombinant DNA vaccine

Intervention Type DRUG

Hepatitis B recombinant DNA 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.

Group Type ACTIVE_COMPARATOR

Combined hepatitis A and B vaccine

Intervention Type DRUG

Combined hepatitis A and B vaccine given to the patients

Interventions

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Hepatitis B recombinant DNA vaccine

Hepatitis B recombinant DNA vaccine

Intervention Type DRUG

Combined hepatitis A and B vaccine

Combined hepatitis A and B vaccine given to the patients

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Jeddah Clinic Hospital

INDUSTRY

Sponsor Role collaborator

Benha University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Hamada imam

MD. - Lecturer at Internal Medicine Department- Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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BN-0517

Identifier Type: -

Identifier Source: org_study_id

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