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

Study Overview
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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.

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

Conditions
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Hepatitis B, Hemodialysis Complication

Intervention / Treatment
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* Drug: Hepatitis B recombinant DNA vaccine
* Drug: Combined hepatitis A and B vaccine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Patient seuentially randomized to either vaccine
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hepatitis B recombinant DNA vaccine<br>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<br>* Hepatitis B recombinant DNA vaccine<br>|
| Active Comparator: Combined hepatitis A and B vaccine<br>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<br>* Combined hepatitis A and B vaccine given to the patients<br>|

What is the study measuring?
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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 |