Comparison of immune response to hepatitis B vaccine in simultaneous injections of Tetanus-diphtheria and B hepatitis vaccines with hepatitis B vaccine alone in Azahra staff having anti-HBs Ab lower than 100 IU/ml
The aim of this study is to determine the cumulative effect of Tetanus-diphtheria vaccine (Td) in immune response emission against hepatitis B vaccine. This is a Randomized Clinical Trial (RCT), not blinded, unicenter, phase III study while placebo was not applied. The population of the study comprised nurses and staff of surgery ward at Alzahra hospital in Isfahan city having less than 100 IU/ml of hepatitis B antibody. Inclusion criteria included individuals whose immune system was not deficient whilst they were HBs Ag negative. Furthermore, those who were previously vaccinated were included in the study, unless they had 100 IU/ml or higher level of Hepatitis B Antibody. Exclusion criteria comprised individuals having hypersensitivity to B hepatitis vaccine. Since all of the staff of Alzahra hospital have health documents and are vaccinated against hepatitis B, individuals having less than 100 IU/ml will be recognizable. All of the individuals were randomly assigned either in intervention or control group in accordance with random number table. Control group was intramuscularly (IM) vaccinated through 40 microgram of recombinant HBsAg (rHBsAg) produced by CUBA-SIA company in the months of 0,1 and 6.The intervention group was vaccinated as well as control group schedule except that it simultaneously was vaccinated by adult Tetanus and Diphtheria (Td) vaccine. Finally, Antibody titer will be compared, after one and six months of the last vaccination, in the above mentioned groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051015999N2
Registration date:2014-08-06, 1393/05/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-06, 1393/05/15
Registrant information
Name
Roya Taleban
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2542
Email address
r.taleban@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Isfahan University of Medical Sciences
Expected recruitment start date
2013-02-14, 1391/11/26
Expected recruitment end date
2013-08-17, 1392/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of immune response to hepatitis B vaccine in simultaneous injections of Tetanus-diphtheria and B hepatitis vaccines with hepatitis B vaccine alone in Azahra staff having anti-HBs Ab lower than 100 IU/ml
Public title
Effect of Tetanus-diphtheria vaccine in promotion of immune response against hepatitis B vaccine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Individuals being Hepatitis B Antigen (HBsAg) negative whilst they were vaccinated against B hepatitis and their antibody titers would be lower than 100 IU/ml. Lack of primary or acquired immune deficiency
Exclusion criteria: Individuals will be excluded from the study and they will be treated if their status of hypersensitivity is recognized.
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq.
City
Isfahan
Postal code
Approval date
2013-01-14, 1391/10/25
Ethics committee reference number
191049
Health conditions studied
1
Description of health condition studied
Hepatitis B
ICD-10 code
B18
ICD-10 code description
Chronic viral hepatitis
Primary outcomes
1
Description
Hepatitis B Antibody titer
Timepoint
1 and 6 months after vaccination
Method of measurement
By ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1:
This intervention was implemented by 40 microgram of rHBsAg produced by CUBA-SIA Company, while Tetanous-diphteria vaccine (Td [0.5ml of toxoid produced at Pasteur Institute]) was simultaneously injected in the first application of rHBsAg in two different sites and the former vaccination continued one and six months later. All of the vaccination programs were implemented through intramuscular injections.
Category
Prevention
2
Description
Intervention 2:
40 microgram of recombinant HBsAg (rHBsAg) produced by CUBA-SIA company in months of 0, 1 and 6
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra University Hospital
Full name of responsible person
Street address
Al-Zahra University Hospital, Sofeh Blvd., Isfahan, Iran.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Isfahan University of Medical Sciences
Full name of responsible person
Peyman Adibi
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences, Hezar-jarib St., Azadi Sq., Isfahan
City
Isfahan
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 Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Roya Taleban
Position
Resident of Community Medicine
Other areas of specialty/work
Street address
Community Medicine Department, School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib Ave., َAzadi Sq.
City
Isfahan
Postal code
Phone
+98 31 3792 2542
Fax
Email
r.taleban@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Mohammad Moafi
Position
PhD Candidate of Immunology
Other areas of specialty/work
Street address
Bu-Ali Sina University, Hamadan,Iran
City
Hamadan
Postal code
Phone
+98 913 113 0938
Fax
Email
mohammoafi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Roya Taleban
Position
Resident of Community Medicine
Other areas of specialty/work
Street address
Community Medicine Department, School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib Ave., َAzadi Sq.
City
Isfahan
Postal code
Phone
+98 31 3792 2542
Fax
Email
r.taleban@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)