Determination of specific antibody titre against Pneumococcus and its relation with recurrent infection in patients with ataxia-telangiectasia and IgA deficiency
- Determination of specific antibodies titre against pneumococcus in patients
- Comparison of clinical manifestations and immunological data in patients with or without defect in specific antibodies production against pneumococcus
Design
Without control group
Settings and conduct
1. Select of patients diagnosed with selective IgA deficiency and ataxia-telangiectasia based on defined criteria
2. Completing questionnaire containg demographic, clinical manifestations and immunological data
Method:
1. We will obtain a sample of 10-5 ml of blood sample of selected patients
2- A 0.5-milliliter dose of non-conjunctiva pneumococcal polyvalent vaccine (PNEUMO 23® Aventis, Pasteur, France) will inject in all patients.
3- Three weeks after pneumococcal vaccination, we will take 10-5 ml of blood of selected patients
4- specific antibody titre against pneumococcal will measure before and after vaccination by ELISA method
5- According to the specific antibody response to pneumococci, the patients will be classified into two groups and their relationship with the presence or absence of specific antibody response against pneumococci in patients with recurrent infections will be evaluated.
Participants/Inclusion and exclusion criteria
Patients diagnosed with selective IgA deficiency and ataxia-telangiectasia based on defined criteria
Intervention groups
All patients receive a 0.5-milliliter dose of non-conjunctiva pneumococcal polyvalent vaccine (PNEUMO 23® Aventis, Pasteur, France).
Main outcome variables
Defect in production of specific antibodies titre against pneumococcus in patients with ataxia-telangiectasia and selective IgA deficiency could be related to manifestation of recurrent infections
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190508043517N1
Registration date:2019-06-17, 1398/03/27
Registration timing:registered_while_recruiting
Last update:2019-06-17, 1398/03/27
Update count:0
Registration date
2019-06-17, 1398/03/27
Registrant information
Name
asghar aghamohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9187
Email address
aghamohammadi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-08, 1398/02/18
Expected recruitment end date
2019-12-09, 1398/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of specific antibody titre against Pneumococcus and its relation with recurrent infection in patients with ataxia-telangiectasia and IgA deficiency
Public title
ٍEvaluation of specific antibody titre against Pneumococcus in patients with Ataxia-telangiectasia and IgA deficiency
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with selective IgA deficiency and ataxia-telangiectasia based on defined criteria
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Tehran University of Medical Sciences
Street address
Nosrat
City
Tehran
Province
Tehran
Postal code
1419853773
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR.TUMS.CHMC.REC.1398.020
Health conditions studied
1
Description of health condition studied
Ataxia-telangiectasia
ICD-10 code
G11.3
ICD-10 code description
Cerebellar ataxia with defective DNA repair
2
Description of health condition studied
IgA deficiency
ICD-10 code
D80.2
ICD-10 code description
Selective deficiency of immunoglobulin A [IgA]
Primary outcomes
1
Description
Ataxia-telangiectasia
Timepoint
Before intervention
Method of measurement
According to the ESID diagnostic criteria
2
Description
IgA deficiency
Timepoint
Before intervention
Method of measurement
According to the ESID diagnostic criteria
3
Description
Sex
Timepoint
Before intervention
Method of measurement
Questionnaire
4
Description
Age
Timepoint
Before intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Determination of the pneumococcus specific antibodies level