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Completed

NCT Number: NCT03149874

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hepatitis B recombinant DNA vaccine

Drug

Hepatitis B recombinant DNA vaccine

Combined hepatitis A and B vaccine

Drug

Combined hepatitis A and B vaccine given to the patients

Primary outcomes

  1. Hepatitis B virus Seroprotection after one month

    Time frame: one month after third dose of the vaccine

    Hepatitis B virus surface antibodies titer after one month

  2. Hepatitis B virus Seroprotection after three months

    Time frame: three months after third dose of the vaccine

    Hepatitis B virus surface antibodies titer after three month

Secondary outcomes

  1. Fever

    Time frame: 4 Days after each vaccination dose

    The proportion of fever among patients in both arms

  2. Pain scale

    Time frame: 1 Hour after each vaccination dose

    Visual pain scale for pain from injection

Sponsors and collaborators

Lead sponsor

Benha University

Other

Collaborators

  • New Jeddah Clinic Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 11, 2017
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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