This study is aimed to assess the effects of hepatitis B vaccine with double dose comparing with the standard dose in chronic hepatic disease patients. A total of 64 patients with hepatitis c or hepatitis induced cirrhosis aged 18-65 and no history of hepatitis B or vaccination against hepatitis B and 32 healthy volunteers, as control group, are recruited. HBSAg and HBV Ab titers are checked for all participants in both groups. If HBSAg is negative and Ab titer is less than 10mIU/ml, the participants are enrolled in the study. HBV vaccine with standard dosage 1ml (20micg/ml) is injected to all healthy participants in control group and 32 patients who are selected randomly from HCV positive group and (HBV vaccine) with double dosage (2ml) is injected to 32 remaining HCV positive patients, intra muscular, three times (months 0, 1, and 6). The Ab titer is checked for all participants one month after the 3rd vaccination the results will be compared between groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902153873N1
Registration date:2010-10-29, 1389/08/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-29, 1389/08/07
Registrant information
Name
Afshin Tahmasbi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1628 3356
Email address
tahmasbi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the immunization of HBV vaccine with double dose comparing standard dose in chronic liver disease patients in Isfahan city 2010-2011
Public title
To evaluate the immunization of HBV vaccine with double dose comparing standard dose in chronic liver disease patients in Isfahan city 2010-2011
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-65 years old, documented chronic HCV positive or cirrhosis
Exclusion criteria: previously HBV vaccination or HBV positive, alcoholic cirrhosis or hepatitis, immune deficiency, CKD with GFR<60ml/min/1.73m2 5, autoimmune hepatitis or cirrhosis
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research, Isfahan University of Medical Sciences
Street address
Hezar jarib St., Isfahan
City
Isfahan
Postal code
Approval date
2008-08-11, 1387/05/21
Ethics committee reference number
187037
Health conditions studied
1
Description of health condition studied
Chronic viral hepatitis C
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C
Primary outcomes
1
Description
Anti HBS titer
Timepoint
Before & 1 month after intervention
Method of measurement
ELISA reader
Secondary outcomes
empty
Intervention groups
1
Description
HBV vaccine (Hepavax-Gene), in months 0, 1, and 6, intramuscular injection
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center sedighe tahere-infectious department
Full name of responsible person
Dr. Afshin Tahmasbi
Street address
Sedighe Tahere Research center, Khoram St., Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research
Street address
Isfahan University of Medical Sciences, Hezar jerib Street, 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 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mohammad Minakari
Position
Assistant Prof. of Gastroentrology
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 1625 5555
Fax
Email
mminakari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mohammad Minakari
Position
Assistant Prof. of Gastroentrology
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 1625 5555
Fax
Email
mminakari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Afshin Tahmasbi
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Alzahra Hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1628 3356
Fax
Email
tahmasbi.afshin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)