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

Benha University

Status: Completed

Conditions: Hemodialysis Complication; Hepatitis B

Treatments: Drug: Combined hepatitis A and B vaccine; Drug: Hepatitis B recombinant DNA vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03149874

BN-0517

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Hepatitis B recombinant DNA vaccine

Active Comparator group

Description:

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.

Treatment:

Drug: Hepatitis B recombinant DNA vaccine

Combined hepatitis A and B vaccine

Active Comparator group

Description:

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.

Treatment:

Drug: Combined hepatitis A and B vaccine