The purpose of this study is evaluating the efficacy of levamisole adjuvant plus hepatitis B vaccination in health care workers which are non-responders to vaccination. This study is a double blind clinical trial. 116 qualified health employees among persons having records in Imam Reza hospital infection control committee were selected and divided systematic randomly into two groups of intervention and control. Vaccination in both groups with 20 micrograms of hepavax into deltoid was done at 0-1-2 months. In intervention group, 50 mgr levamisole was used orally twice daily during 6 days before till 6 days after receiving each dose of vaccine and control group was given placebo drug instead of levamisole as same. Second dose of vaccine injection with 50 mg drug was used twice a day and 1 month after the third dose, the rate of their antibody variation was used.
Inclusion criteria: employees who have a history of hepatitis B vaccination and they aren’t immunized against this disease (HBsAb under 10); completing an informed consent form.
Exclusion criteria: employees with history or facing with positive HBsAg and HBcAb hepatitis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012110417N3
Registration date:2014-03-17, 1392/12/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-17, 1392/12/26
Registrant information
Name
Babak Sayad
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 3957
Email address
babaksayad@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of adjuvant levamisole user and levamisole non-user with hepatitis B vaccination in vaccine non-responders health care workers
Public title
Effect of levamisole adjuvant plus hepatitis B vaccine in vaccine non-responders health care workers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: employees who have a history of hepatitis B vaccination and they aren’t immunized against this disease (HBsAb under 10); completing an informed consent form.
Exclusion criteria: employees with history or facing with positive HBsAg and HBcAb hepatitis
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti bulvard, Vice Chancellor for Research Affairs
City
Kermanshah
Postal code
6714673159
Approval date
2013-11-20, 1392/08/29
Ethics committee reference number
35856/پ/7/420
Health conditions studied
1
Description of health condition studied
Hepatitis B vaccination
ICD-10 code
Z24.6
ICD-10 code description
Need for immunization against viral hepatitis
Primary outcomes
1
Description
Antibody titer to hepatitis B
Timepoint
One month after starting intervention - three months after the first intervention - one month after the last intervention
Method of measurement
Laboratory measurement of antibody titer
Secondary outcomes
1
Description
Side effects of medication or placebo
Timepoint
During the study period
Method of measurement
Interview
Intervention groups
1
Description
In intervention group, 50 mgr levamisole is used orally twice daily during 6 days before till 6 days after receiving each dose of vaccine (20 micrograms hepavax vaccine into deltoid at 0-1-2 months)
Category
Treatment - Drugs
2
Description
The control group was given placebo instead of levamisole
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Liver Disease and Hepatitis
Full name of responsible person
Dr. Armin Vazirian
Street address
Research Center for Liver Disease and Hepatitis, Imam Reza hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
koroush hamzehee
Street address
Building No.2, Shahid Behesht bulvardi, Vice Chancellor for Research Affairs
City
Kermanshah
Grant name
38275
Grant code / Reference number
38275
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Armin Vazirian
Position
Assistant of Infection Diseases
Other areas of specialty/work
Street address
Liver Disease and Hepatitis Research Center,Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6330
Fax
Email
arminawa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Babak Sayad
Position
Associate Professor of Infectious Diseases
Other areas of specialty/work
Street address
Liver Disease and Hepatitis Research Center,Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6342
Fax
Email
babaksayad@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Armin Vazirian
Position
Assistant of Infection Diseases
Other areas of specialty/work
Street address
Liver Disease and Hepatitis Research Center,Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6342
Fax
Email
armainawa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)