HBsAg positive patients would be referred from laboratories in all over Guilan state and would be evaluated for Inclusion and Exclusion criteria. These subjects will be allocated to study groups using simple randomization. Cases receive six monthly doses of hepatitis B recombinant vaccine (Heberbiovac HB) in Intradermal (id) form. Controls receive no vaccine but normal saline as a placebo. We will compare cases with controls according to their response to vaccination. The response to vaccination is defined as loss of HBsAg and appearance of anti-HBs, loss of HBeAg, undetectable HBV-DNA and persistence of normal ALT levels in the post vaccination period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706131155N3
Registration date:2008-11-10, 1387/08/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2008-11-10, 1387/08/20
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
gastrointestinal and liver disease research center (GLDRC)
Expected recruitment start date
2007-01-29, 1385/11/09
Expected recruitment end date
2009-01-29, 1387/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized placebo-controlled double blind study to evaluate intradermal vaccination in hepatitis B healthy carriers to eliminate virus
Public title
The efficacy of specific hepatitis B virus (HBV) vaccination, in Intradermal form, in healthy carriers of HBV to eliminate virus
Purpose
Treatment
Inclusion/Exclusion criteria
Including hepatitis B healthy carriers (positive HBsAg with normal alanine transaminase level).
Excluding D.M or other autoimmune diseases, chronic or serious medical diseases, malnutrition, positive for anti-HIV, anti-HCV and Anti-HDV, pregnancy, receiving any antiviral medication, alcohol intake daily, refusing to give informed consent and so increase in ALT or getting a serious disease during the project and volunteer refusing to continue.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
gastrointestinal and liver disease research center (GLDRC)
Street address
gastrointestinal and liver disease research center (GLDRC) - Razi hospital- Sardar Jangal ave.
City
Rasht
Postal code
Approval date
2006-12-30, 1385/10/09
Ethics committee reference number
31/3/85/201
Health conditions studied
1
Description of health condition studied
Hepatitis B
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
undetectable HBV-DNA
Timepoint
6th month and 12th month
Method of measurement
PCR
2
Description
loss of HBsAg and appearance of anti-HBs
Timepoint
6th month and 12th month
Method of measurement
ELIZA test
Secondary outcomes
1
Description
clinical situation and possibly side effects
Timepoint
monthly
Method of measurement
clinically
Intervention groups
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
gastrointestinal and liver disease research center (GLDRC)
Full name of responsible person
Dr.Fariborz Mansour-Ghanaei
Street address
gastrointestinal and liver disease research center (GLDRC), Razi hospital, Sardar Jangal Ave.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
guilan university of medical siences
Full name of responsible person
Farahnaz Joukar
Street address
gastrointestinal and liver disease research center (GLDRC) - Razi hospital - Sardar Jongal Ave.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
guilan university of medical siences
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
gastrointestinal and liver disease research center (GLDRC)
Full name of responsible person
Farahnaz Joukar
Position
assistant of gastrointestinal and liver disease research center (GLDRC)
Other areas of specialty/work
Street address
gastrointestinal and liver disease research center (GLDRC) - Razi hospital - Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
+98 13 1553 4951
Email
f_jokar@gums.ac.ir
Web page address
www.gldrc.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
gastrointestinal and liver disease research center (GLDRC)
Full name of responsible person
Dr.Fariboraz Mansou-Ghanaei
Position
Head / Full Professor of Internal Medicine & Gastroenterology
Other areas of specialty/work
Street address
gastrointestinal and liver disease research center (GLDRC) - Razi hospital - Sardar Jangal Ave.
City
Rasht
Postal code
Phone
Fax
Email
ghanaei@gums.ac.ir
Web page address
www.gldrc.org
Person responsible for updating data
Contact
Name of organization / entity
gastrointestinal and liver disease research center (GLDRC)
Full name of responsible person
Dr.Helia Valaee-Barhagh
Position
researcher
Other areas of specialty/work
Street address
gastrointestinal and liver disease research center (GLDRC) - Razi hospital - Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
+98 13 1553 4951
Email
h.barhagh79@gmail.com
Web page address
www.gldrc.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)