The objective of the present randomized study is to compare the efficacy of low dose intradermal to conventional doses of intramuscular injection of hepatitis B vaccine in end stage renal failure patients.
A total of 40 patients will be entered in this study. Inclusion criteria are over the age of 14, Anti HBS Ab titre below 10 U/ml and history of at least a course of vaccination against Hepatitis B. Exclusion criteria are malignant diseases, kidney transplantation and any cause of immunodeficiency such as AIDS. This patients randomly divided in 2 groups, in one group 4 intramuscular injections of 40μg of Euvax B (in mounts 0, 1, 2 and 6 totally 160 µg) and in other group intradermal injection of 2.5 µg of Euvax B in 2 different sites(totally 5µg) every 2 weeks to 2 mounts and then mountly to end of mount 4 and one injection in the sixth mount (totally 40 μg)will be injected. In all patients Anti HIV and Anti HCV will be measured and history of intravenous drug addiction, injection of blood products, duration of CRF, and type of dialysis will be recorded. The antibody titer (primary outcome) is measured in 2 groups at the end of 1, 6 and 12 mounts after end of the course of vaccination. In this study anti-HBs antibody level over 10 U/ml is considered protective.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805122276N1
Registration date:2009-12-05, 1388/09/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-12-05, 1388/09/14
Registrant information
Name
Behzad Bijani
Name of organization / entity
Qazvin University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 4808
Email address
bbijani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Qazvin University of Medical Sciences
Expected recruitment start date
2008-09-06, 1387/06/16
Expected recruitment end date
2010-03-06, 1388/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy between intramuscular and intradermal injection of Hepatitis B vaccine in Buali Sina dialysis centre, Qazvin.
Public title
Comparison of efficacy between intramuscular and intradermal injection of Hepatitis B vaccine in Buali Sina dialysis centre, Qazvin.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: CRF patients who are under dialysis (hemodyalisis or peritoneal dialysis) in Bualisina dialysis centre, HBsAg lower than 10 U/ml and at least a previous course of hepatitis B vaccination.
Exclusion criteria: Presence of malignancy, severe malnutrition, positive HBsAg, kidney transplantation, immunocompromising disease such as AIDS.
Age
From 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Shaheed Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
Approval date
2008-04-13, 1387/01/25
Ethics committee reference number
28/20/222
Health conditions studied
1
Description of health condition studied
End-stage renal disease
ICD-10 code
N18.0
ICD-10 code description
ٍEnd-stage renal disease
Primary outcomes
1
Description
anti HBs antibody titre
Timepoint
Before intervention, 7, 12, and 18 months after intervention
Method of measurement
anti HBs antibody titre measurement
Secondary outcomes
empty
Intervention groups
1
Description
Recombinant Hepatitis B vaccine (Euvax B®) 2.5 μg at 2 different sites (totally 5µg) every 2 weeks untill 2 months and then monthly until end of the forth month and one injection at the sixth month (40 μg total dose) by intradermal injection.
Category
Prevention
2
Description
Recombinant Hepatitis B vaccine (Euvax B®) 40 μg at months: 0-1-2-6 (160 μg total dose) by intramuscular injection.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali Sina Hospital
Full name of responsible person
Behzad Bijani
Street address
Buali Sina Hospital
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Saeed Asefzadeh,
Street address
Vice-chancellor for Research, Qazvin University of Medical Sciences, Shahid Bahonar Blvd.
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Behzad Bijani
Position
Associate Professor of Infectious diseases
Other areas of specialty/work
Street address
Buali Sina Hospital
City
Qazvin
Postal code
Phone
+98 28 1335 4808
Fax
Email
bbijani@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Scienses
Full name of responsible person
Behzad Bijani
Position
Infectious diseases specialist
Other areas of specialty/work
Street address
Buali Sina Hospital
City
Qazvin
Postal code
Phone
Fax
Email
bbijani@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical sciences
Full name of responsible person
Behzad Bijani
Position
Associate Professor of Infectious diseases
Other areas of specialty/work
Street address
Buali Sina Hospital
City
Qazvin
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)