The impact of adulthood booster dose of Hepatitis B vaccine on antibody response in medical and nursing students of Qazvin University of Medical Sciences: a before-after study.
The aim of this research is the investigation of the efficacy of adulthood booster dose of hepatitis B vaccine on HBs antibody titer in participants who had vaccinated in childhood. In this interventional study, the titer of HBs antibody in medical and nursing students of Qazvin university will be checked by ELISA method before entering to hospital wards. Students with a diagnosis of hepatitis B and students with a previous history of booster dose vaccination will be excluded from the study. The sample size in the first period of the study is 200 students. Then in 120 students with an antibody titer less than 10 Units/L, an intramuscular booster dose of 20 µg recombinant hepatitis B vaccine (Euvax B, LG corporations, South Korea) will be injected and after a month, the HBs antibody titer will be checked by ELISA method. This is a “before-after” study and has not a control group. Main outcome measures are HBs antibody titer as the primary outcome variable and adverse reactions to vaccination as secondary outcome variable.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510142276N3
Registration date:2015-11-22, 1394/09/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-22, 1394/09/01
Registrant information
Name
Behzad Bijani
Name of organization / entity
Qazvin University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 4808
Email address
bbijani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of adulthood booster dose of Hepatitis B vaccine on antibody response in medical and nursing students of Qazvin University of Medical Sciences: a before-after study.
Public title
The impact of adulthood booster dose of Hepatitis B vaccine on antibody response in students
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: medical or nursing student before entering the clinical wards. Exclusion criteria: students with chronic hepatitis B; students with previous history of booster vaccination
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
No. 5, Bahonar Blvd, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Approval date
2015-09-30, 1394/07/08
Ethics committee reference number
IR.QUMS.REC.1394.120
Health conditions studied
1
Description of health condition studied
Hepatitis B
ICD-10 code
B18.1
ICD-10 code description
Chronic (viral) hepatitis B
Primary outcomes
1
Description
Anti HBS antibody titer
Timepoint
One month after vaccination
Method of measurement
Serology (ELISA)
Secondary outcomes
1
Description
Vaccination side effects
Timepoint
During a month period after vaccination
Method of measurement
Participants' report
Intervention groups
1
Description
Single dose intramuscular injection of 20 microgram of recombinant hepatitis B vaccine (Euvax B, LG corporations, South Korea)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Infectious diseases ward, Bualisina Hospital
Full name of responsible person
Behzad Bijani
Street address
No. 112, Buali St
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Qazvin University of Medical Sciences
Full name of responsible person
Dr Taghi Naserpour
Street address
No. 15, Shahid Bahonar Blvd, Vice Chancellor for Research, Qazvin University of Medical Sciences
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Farzaneh Jafari zavieh kord
Position
Resident
Other areas of specialty/work
Street address
No. 112, Buali St, Bualisina Hospital
City
Qazvin
Postal code
Phone
+98 28 3333 2930
Fax
Email
drjafari587@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Behzad Bijani
Position
Assistant professor, Infectious Diseases Specialist
Other areas of specialty/work
Street address
No. 112 Buali St, Bualisina Hospital
City
Qazvin
Postal code
Phone
+98 28 3333 2930
Fax
Email
bbijani@qums.ac.ir; dr.bijani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Behzad Bijani
Position
Assistant Professor, Infectious Diseases
Other areas of specialty/work
Street address
No. 112, Buali St, Bualisina Hospital
City
Qazvin
Postal code
Phone
+98 28 3333 2930
Fax
Email
bbijani@qums.ac.ir; dr.bijani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)