HBs-Ab titer Determining in Autistic child and immunological memory assessment by booster injection, as well as evaluation of viral factors in cases of non-responsiveness to hepatitis B vaccine in compassion with control.
persistence of anti-HBs antibody determination between autistic and healthy children after primary vaccination achievement .
Determination of non-responsiveness rate to hepatitis B vaccine in Autistic child in compression with control after full vaccination.
Design
An intervention, descriptive and prospective study and clinical trial has been conducted on autistic children with healthy children as control and outcome assessment.
Settings and conduct
Experiments are carried out at Hepatitis B Laboratory of Virology Department of School of Public Health, Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
To included in the study in ASD group
The child have Proven autism, parental consent for their child's participation. No Sickness and no fever.
to included in the study in control group,The child be healthy and have parental consent.
for excluding from study
Every time parents abandon cooperation
The child has an antibody level higher than 10 mIU/mL or reaches the antibody titer higher than 10 mIU/ml after vaccine injection.
Intervention groups
Hepatitis B vaccine will be injected to َAutistic child and healthy controls whom have antibody titre less than 10 mIU/mL
Main outcome variables
The responsiveness rate for the hepatitis B vaccine will be determined in children with autism.
Antibody durability and prevalence of hepatitis B virus seromarkers will be determined in both groups.
The immunological memory statues against HBV vaccine will be disclosed.
General information
Reason for update
Acronym
ASD
IRCT registration information
IRCT registration number:IRCT20130904014562N2
Registration date:2018-04-18, 1397/01/29
Registration timing:retrospective
Last update:2018-04-18, 1397/01/29
Update count:0
Registration date
2018-04-18, 1397/01/29
Registrant information
Name
Seyed Mohammad Jazayeri
Name of organization / entity
Hepatitis B Lab-Dept Virology
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 2660
Email address
jazayerism@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
2017-02-19, 1395/12/01
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
empty
Scientific title
Evaluation of response to hepatitis B vaccine in Autistic child in comparison with control group
Public title
Responsiveness to the hepatitis B vaccine in Autistic child
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of autism in the child
Maximum age 15 years
Parental consent regarding the participation of their child in phlebotomy and vaccine injection
Exclusion criteria:
Parental dissatisfaction
HBs-Ab titer Existence or increase above 10 mIU/mL
Age
To 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
105
Actual sample size reached:
105
Randomization (investigator's opinion)
N/A
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 Tehran University of Medical Sciences
Street address
Hepatitis B Lab-Department Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14155-6446
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.TUMS.REC 139502754
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
The variable in the study is the HBs-Ab titre. By Booster injection HBs-Ab titer will be increased and marked by ELISA
Timepoint
Evaluation time is before vaccine administration and one month after vaccine injection
Method of measurement
ELISA method employed
Secondary outcomes
empty
Intervention groups
1
Description
In the control group, children who have HBs-Ab titer less than 10 mIU/mL receive hepatitis B vaccine.
Category
Prevention
2
Description
In the ASD group, children who have HBs-Ab titer less than 10 mIU/mL receive hepatitis B vaccine.:
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Behara Rehabilitation Center, Shahid Beheshti University
Full name of responsible person
Haleh Ofoghi
Street address
Family Research Institute, in front of the Faculty of Literature, Shahid Beheshti University, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 5430
Fax
+98 21 2990 2368
Email
halehofoghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohammad jazayeri
Street address
Hepatitis B Lab-Department Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15155-6446
Phone
+98 21 8899 2660
Fax
+98 21 8899 2660
Email
jazayerism@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed mohammad Jazayeri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Hepatitis B Lab-Department Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15155-6446
Phone
+98 21 8899 2660
Fax
+98 21 8899 2660
Email
jazayerism@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Jazayeri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Hepatitis B Lab-Department Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15155-6446
Phone
+98 21 8899 2660
Fax
+98 21 8899 2660
Email
jazayerism@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Jazayeri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Hepatitis B Lab-Department Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15155-6446.
Phone
+98 21 8899 2660
Fax
+98 21 8899 2660
Email
jazayerism@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
All people who are willing to work in this field
Under which criteria data/document could be used
Purely scientific research
From where data/document is obtainable
Hepatitis B Lab-Department Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
What processes are involved for a request to access data/document
Send request type by email
Confirm and validate email
Reply to the email and send the documentation