Aim: Comparing the Efficacy and Safety of Hepatitis B vaccine of Pasteur Institute of Iran and Cuban Heber biotec Company’s in Iranian healthy volunteers
Study Design: Randomized, non-controlled with placebo, single center, Phase 2 clinical trial,
Study Population: Iranian healthy volunteers in Tehran
Healthy volunteers
completed inform consent
Exclusion criteria:
HBsAg+ or HBcAb+ patients
Previous incubation of hepatitis B vaccine or serum HBsAb >10 mIU/ml before the first dose of vaccine incubation
Patients with: Thalassemia, any malignancies, Immunodeficiency, HIV, DM, Liver failure and dialysis patients
Sample size:440
intervention: Incubation of hepatitis B vaccine of Pasteur Institute of Iran and Cuban Heber biotec Company’s in 3 course
Initial outcome: Change in HBsAb level
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109113307N5
Registration date:2011-09-19, 1390/06/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-09-19, 1390/06/28
Registrant information
Name
Seyed Moayed Alavian
Name of organization / entity
BRCGL-THC
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 2072
Email address
info@brcgl.ir
Recruitment status
Recruitment complete
Funding source
Iran's Pasteur Institute (IPI)
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Efficacy and Safety of Hepatitis B vaccine of Pasteur Institute of Iran and Cuban Heber biotec Company’s in Iranian healthy volunteers
Public title
Comparing the Efficacy and Safety of Hepatitis B vaccine of Pasteur Institute of Iran and Cuban Heber biotec Company’s in Iranian healthy volunteers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy volunteers
completed inform consent
Exclusion criteria:
HBsAg+ or HBcAb+ patients
Previous incubation of hepatitis B vaccine or serum HBsAb >10 mIU/ml before the first dose of vaccine incubation
Patients with: Thalassemia, any malignancies, Immunodeficiency, HIV, DM, Liver failure and dialysis patients
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
440
Randomization (investigator's opinion)
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
Ethics committee of Baqyatallah University of Medical Sciences
Street address
Baqyatallah University of Medical Sciences, Mollasdra Ave., Vanak Squ
City
Tehran
Postal code
19395-5487
Approval date
2010-02-28, 1388/12/09
Ethics committee reference number
340/22/س
Health conditions studied
1
Description of health condition studied
Acute Hepatitis B
ICD-10 code
B16
ICD-10 code description
Acute hepatitis B
2
Description of health condition studied
Chronic (viral) hepatitis B
ICD-10 code
B18.1
ICD-10 code description
Chronic (viral) hepatitis B
Primary outcomes
1
Description
HBsAb serum titre
Timepoint
Respectively, one, six and seven month after incubation of first vaccine
Method of measurement
ELISA test
Secondary outcomes
1
Description
Vaccination adverse events
Timepoint
Respectively, one, six and seven month after incubation of first vaccine
Method of measurement
Based on history and measured blood biochemical variables
Intervention groups
1
Description
Hepatitis B vaccine produced by Pasteur Institute of Iran (intervention group) in 3 course. Month 0, month 1 and month 6.
Category
Prevention
2
Description
Hepatitis B vaccine produced by Heber Biotech Institute of Cuba (Control group) in 3 course. month 0, month 1, and month six.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqyatallah University of Medical Sciences
Full name of responsible person
Mostafa Shafiei
Street address
Ground Floor of Baqiyatallah Hospital, Baqiyatallah Medical University, Mollasdra Ave., Vanak Squ
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pasteur Institute of Iran (IPI)
Full name of responsible person
Hanieh Mahdiani
Street address
NO. 69, Pasteur Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pasteur Institute of Iran (IPI)
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
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Full name of responsible person
Mostafa Shafiei
Position
M.D.
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 912 550 8701
Fax
Email
m.shafiei@brcgl.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Full name of responsible person
Sayed Moayed Alavian
Position
M.D.
Other areas of specialty/work
Street address
Ground Floor of Baqiyatallah Hospital, Baqiyatallah Medical University, Mollasdra Ave., Vanak Squ
City
Tehran
Postal code
Phone
+98 21 8861 4523
Fax
Email
editor@hepatmon.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Full name of responsible person
Mostafa Shafiei
Position
M.D.
Other areas of specialty/work
Street address
Ground Floor of Baqiyatallah Hospital, Baqiyatallah Medical University, Mollasdra Ave., Vanak Squ
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)