Fifty two person of vaccinated individuals who have HBsAb <10 after 3 dose hepatitis B vaccination and with negative HBc Ab, HBs Ab, HBs Ag are included. Exclusion criteria are: positive serologic evidence of Hepatitis B infection- chronic use of Atorvastatin- immunosuppressive illness. Included individuals will be allocated randomly in 2 groups: group A: will receive one 40 mg Atorvastatin tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left deltoid muscle; group B: will receive one placebo tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left deltoid muscle. HBsAb will be measured in serum 4-8 weeks after vaccination in both groups with quantitative ELIZA method. Interlukins measurement with PCR method after white blood cell culture of both groups and exposed with vaccine in vitro, will be done. Then all data will be analyzed with SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109147556N1
Registration date:2011-12-20, 1390/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-20, 1390/09/29
Registrant information
Name
Nematollah Jonaidi Jafari
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 0062
Email address
jonaidi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-07-20, 1391/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of short-term Atorvastatin treatment on vaccination efficacy in nonresponder persons to Hepatitis B vaccine
Public title
Effects of Atorvastatin on Hepatitis B vaccination efficacy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: HbsAb<10 after 3 dose hepatitis B vaccination- negative HBsAb- negative HBcAb- negative HBsAb.
ٍExclusion criteria: positive serologic evidence of Hepatitis B infection- chronic use of Atorvastatin- immunosuppressive illness
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
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
Baqiyatallah University of Medical Siences Ethics Committee
Street address
Baqiyatallah University of Medical Sciences, Mollasadra street, Vanak Sq.
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
28
Health conditions studied
1
Description of health condition studied
Immunization against Viral Hepatitis B
ICD-10 code
Z24.6
ICD-10 code description
Need for immunization against Viral Hepatitis
Primary outcomes
1
Description
HBsAb level in serum
Timepoint
Before Atorvastatine use and 1 month after vaccination
Method of measurement
Quantitative ELIZA
2
Description
IL-4 , IL17 , TGFB , IFN-gamma
Timepoint
After WBC culture and exposure with vaccine in vitro
Method of measurement
Polymerase Chain Reaction (PCR)
Secondary outcomes
1
Description
Immunization against viral hepatitis B
Timepoint
Befor and 1 month after vaccination
Method of measurement
Quantitative ELIZA
Intervention groups
1
Description
Control Group: will recive one placebo tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeaset-derived Hepatitis B vaccine intramuscular in left Deltoid muscle.
Category
Placebo
2
Description
Intervention Group:will recive one 40 mg Atorvastatin tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeaset-derived Hepatitis B vaccine intramuscular in left Deltoid muscle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences center of Military Health Reaserches
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Hasan Saadat
Street address
Baqiyatallah University of Medical Sciences, Mollasadra strett, Vanak Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
Baqiyatallah Medical Sciences University
Full name of responsible person
Dr Nematollah Jonaidi Jafari
Position
Head of Center for Military Health Researches
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Mollasadra strett, Vanak Sq.
City
Tehran
Postal code
Phone
+98 21 8860 0062
Fax
Email
jonaidi@bmsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Nematollah Jonaidi Jafari
Position
Specialist in Infectious disease
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Mollasadra strett, Vanak Sq.
City
Tehran
Postal code
Phone
+98 218860062
Fax
Email
jonaidi@bmsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Nematollah Jonaidi Jafari
Position
Specialist in infectious disease
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Mollasadra strett, Vanak Sq.
City
Tehran
Postal code
Phone
+98 218860062
Fax
Email
jonaidi@bmsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)