This study compared the response rate of hepatitis B vaccination (HBV) in chronic renal failure (CRF) and end stage renal disease (ESRD) patients. One hundred and eighty participants were enrolled into this study. The CKD patients who were in pre-dialysis stage received a three, 40-μg dose course of the Recombivax HBV vaccine, intramuscularly, at 0, 1 and 6 months. The patients who were under hemodialysis received a four 40-μg dose course of the Recombivax HBV vaccine at 0, 1, 2 and 6 months, intramuscularly. Rate of seroconversion was evaluated 3 months after vaccination and compared between groups. Seroconversion was defined as hepatitis B surface antibody titer greater than 10 IU.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905163325N4
Registration date:2011-01-14, 1389/10/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-14, 1389/10/24
Registrant information
Name
Majgan Jalalzadeh
Name of organization / entity
Zanjan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1426 6934
Email address
jmojgan@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2008-03-20, 1387/01/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Hepatitis B vaccination in developing Ab against Hepatitis B in patients with chronic kidney disease before dialysis
Public title
the effect of Hepatitis B vaccination in patients with chronic kidney disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age more than18 years old, presence of Chronic Kidney Disease in the stages of 2 to 4
Exclusion criteria: Presence of severe CKD which is predicted to result in end stage renal disease over a year, HBV positive, presence of lymphoprolifrative disease, receiving immunosuppressive drugs, previous HBV vaccination
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
N/A
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Street, Zanjan, Iran
City
Zanjan
Postal code
Approval date
2010-04-14, 1389/01/25
Ethics committee reference number
19/3-236
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18
ICD-10 code description
Chronic renal failure
Primary outcomes
1
Description
Serum HBSAb
Timepoint
3 months after the last dose of vaccination
Method of measurement
Laboratory kits
Secondary outcomes
1
Description
HBS Ag
Timepoint
3 months after the last dose ofl anti HBV vaccination
Method of measurement
Laboratory kits
Intervention groups
1
Description
Intervention group: 40 micrograms HBV vaccine at the months of 0, 1, 2, 6 in patients with ESRD under dialysis
Category
Prevention
2
Description
Control group: 40 micrograms HBV vaccine at the months of 0, 1, and 6 in patients with chronic kidney disease at the stages of II - IV
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis center of Vali-e-Asr hospital
Full name of responsible person
Street address
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ms. Eskandari
Street address
Faculty of Medicine, Zanjan University of Medical Sciences, Shahrak e karmandan street, Zanjan, Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Mirzamohammadi
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of medicine, Zanjan University of Medical Sciences, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 912 610 9678
Fax
Email
fateme_mm@yahoo.co.uk
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Mirzamohammadi
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 912 610 9678
Fax
Email
fateme_mm@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)