Healthy family members of hepatitis B patients who have not previously received the hepatitis B vaccine and who test negative for HBs Ag and HBs Ab are recruited in a randomized fashion into a double-blind clinical trial. The subjects are randomly divided into an intervention group and a control group. Those in the intervention group receive the hepatitis B vaccine in three doses at 0, 1, and 6 months co-administered with levamisole tablet 50mg, while those in the control group are given the hepatitis B vaccine with placebo. The HBs Ab levels are then measured one month after the final dose of the vaccine and the results are compared in order to evaluate the effect of levamisole co-administration on the degree of response to the hepatitis B vaccine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110618915N2
Registration date:2014-11-19, 1393/08/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-19, 1393/08/28
Registrant information
Name
Mousalreza Hosseini
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 80 1274 2513
Email address
hoseinimr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashad University Of Medical Sciences
Expected recruitment start date
2014-04-27, 1393/02/07
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of levamisole co-administration on the level of immune response to hepatitis B vaccine in healthy individuals.
Public title
The role of levamisole co-administration hepatitis B vaccine in immunization.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 16 years old and older without a history of a chronic disease or previous hepatitis B vaccination.
Exclusion criteria: current smoking and/or addiction to any form of drug; body mass index above 30 kg/m2; previous history of hepatitis B vaccination or infection; positive testing for HBs Ag or HBs Ab; any current chronic and/or acute disease.
Age
From 16 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
217
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
Mashad University Of Medical Sciences
Street address
Goreyshi Building, Daneshgah Street, Mashad University Of Medical Sciences
City
Mashhad
Postal code
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
920550
Health conditions studied
1
Description of health condition studied
Need for immunization against viral hepatitis
ICD-10 code
Z24.6
ICD-10 code description
Persons with potential health hazards related to communicable diseases
Primary outcomes
1
Description
Response rate to the hepatitis B vaccine when levamisole is co-administered
Timepoint
HBs Ab levels are measured one month after the final dose of the vaccine
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Placebo: administered orally from one week prior to every hepatitis-B vaccination dose to one week after.
Category
Treatment - Drugs
2
Description
Intervention: levamisole administered orally from one week prior to every hepatitis-B vaccination dose to one week after.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mousalreza Hosseini
Street address
Internal Department, Ghaem Hospital, Ahmadabad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi Biulding, Danseshgah Street, Research Vice Chanecellary, Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?