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

NCT03149874 | Completed DMC

• 1 other identifier: BN-0517
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis B; Hemodialysis Complication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Fever

  4 Days after each vaccination dose

• Pain scale

  1 Hour after each vaccination dose

Study Arms (2)

Hepatitis B recombinant DNA vaccine

ACTIVE COMPARATOR

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

Combined hepatitis A and B vaccine

ACTIVE COMPARATOR

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

Interventions

Hepatitis B recombinant DNA vaccine DRUG

Hepatitis B recombinant DNA vaccine

Hepatitis B recombinant DNA vaccine

Combined hepatitis A and B vaccine DRUG

Combined hepatitis A and B vaccine given to the patients

Combined hepatitis A and B vaccine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead
• New Jeddah Clinic Hospital: collaborator

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. - Lecturer at Internal Medicine Department- Faculty of Medicine

Model Details: Patient seuentially randomized to either vaccine

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 11, 2017
• Study Start: December 1, 2014
• Primary Completion: April 30, 2017
• Study Completion: May 1, 2017
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share