There are different strategies to improve immune response to HBV vaccine. One of them is to use different adjuvant such as GMCSF or tetanus vaccine. The aim of this study is to evaluate the effectiveness of dT vaccine on HBS Ab level in non-responder dialysis patients while being given simultaneously HBV vaccine. We initiated the study in Mar. 2009. 62 (hemo and peritoneal) dialysis patients who passed at least 3 dose HBV vaccination schedule and had HBS Ab less than 10, were traced for one year. The patients were divided into two groups, A (32 patients) and B (30 patients). Both of them received 3 dosees of HBV vaccine (40 µgr) intramuscularly into their left deltoid-muscle at 0, 1 and 6 months, but group B received dT vaccine into right deltoid-muscle simultaneously as well as first dose of HBV vaccine. We will test HBS Ab with ELISA method with Dia plus kits, 1-2m and 6m after completing vaccination. We hope our study will come to an end in August 2010
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812093454N1
Registration date:2010-04-24, 1389/02/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Nasrin Namdari Ghareghani
Name of organization / entity
Isfahan Medical University
Country
Iran (Islamic Republic of)
Phone
+98 31 1651 0129
Email address
n_namdari@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Science ,Vice Chancellor For Research
Expected recruitment start date
2009-03-15, 1387/12/25
Expected recruitment end date
2010-08-06, 1389/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effectiveness of dT vaccine on immune response to HB vaccine in non responder dialysis patients
Public title
The evaluation of effectiveness of dT vaccine on immune response to HB vaccine in non responder dialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion:1)age>=18yr,2)hemodialysis and peritoneal dialysis patients,3)comleted at least 3 dose HBV vaccine schedule and had HBS Ab <10
Exclusion:1)no compliance,2)renal transplant
Age
From 18 years old to 149 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Medical University
Street address
Isfahan
City
Isfahan
Postal code
Approval date
2009-03-01, 1387/12/11
Ethics committee reference number
388030
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
ESRD
Primary outcomes
1
Description
HBS Ab titer
Timepoint
1-2 m and 6 month after completing vaccination
Method of measurement
ELISA
Secondary outcomes
1
Description
--------
Timepoint
-----
Method of measurement
------
Intervention groups
1
Description
dT vaccine injection simultaneously with first dose of HBV vaccine
Category
Treatment - Drugs
2
Description
HBV vaccine (40µgr) injection at 0,1,6 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
1)Hemodialysis Unit,Khorshid Hospital
Full name of responsible person
Street address
Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Hemodialysis Unit,Alzahra Hospital
Full name of responsible person
Street address
Isfahan
City
Isfahan
3
Recruitment center
Name of recruitment center
Hemodialysis Unit,shareati Hospital
Full name of responsible person
Street address
Isfahan
City
Isfahan
4
Recruitment center
Name of recruitment center
Hemodialysis Unit,Saee Hospital
Full name of responsible person
Street address
City
Khomeini Shahr
5
Recruitment center
Name of recruitment center
Hemodialysis Unit,Emam Khomeini Hospital
Full name of responsible person
Street address
Isfahan
City
Falavarjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Science
Full name of responsible person
Vice Chancellor For Research
Street address
Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University Of Medical Science
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
Isfahan University Of Medical Sciences
Full name of responsible person
Dr.Shahrzad Shahidi
Position
Assistant Prof.Nephrology
Other areas of specialty/work
Street address
Internal Medicine Unit, School of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1663 6858
Fax
Email
shahidi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Medical University Of Science
Full name of responsible person
Dr.Shahrzad Shahidi
Position
Assistant Prof.Nephrology
Other areas of specialty/work
Street address
Internal Medicine Unit, School of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1663 6858
Fax
Email
shahidi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Medical University of Science
Full name of responsible person
Dr.Nasrin Namdari ghareghani
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Department of Nephrology, Alzahra Hospital
City
Isfahan
Postal code
Phone
+98 31 1651 0129
Fax
Email
n_namdari@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)