Comparison of specific-antibody formation in response to pneumococcal vaccination in children with systemic lupus erythematosus, and asthmatic control group, at Shiraz Namazi hospital and Imam Reza clinic
In the present paper immunogenicity and safety of pneumococcal vaccine using SLEDAI and also humeral immunity function from the standpoint of specific antibody formation against polysaccharides antigens in children with Systemic Lupus Erythematosus are studied.
In this study thirty children (range: 2 to 18 years old) with Systemic Lupus Erythematosus were participated as the case group, and thirty age and sex matched asthmatic children were participated as control group. The participants were selected by convenience sampling method. Exclusion criteria were fever, recent immunization, history of previous pneumococcal vaccination, history of hypersensitivity reaction to vaccination, platelet level less than 50,000 , mixed connective tissue disorders and IVIG injection in last 3 months.
Thirty age and sex matched asthmatic controls were selected from children who attended out-patient clinic of asthma .It should be mentioned that controls were selected from mild asthmatic patients, and the patients with persistent or severe asthma and those with history of immunosuppressive therapy or PO corticosteroid consumption and those who has history of other immunodeficiency disorders were excluded from the control group.
Informed consent was obtained from all participants or their parents. Before vaccination 5 cc venous blood sample was taken from both case and control group,then each participant received 0.5 ml intradeltoid injection of 23-valent pneumococcal vaccine . At least 3 weeks after vaccination, the patients (both groups) were visited at immunology clinic and 5cc venous blood sampling was done again.Both pre-vaccination and post-vaccination serum samples of all participants were sent to Allergy Research Center of Shiraz and anti-pneumococcal specific IgG titer was measured using enzyme linked immunoassay (ELISA).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811293361N1
Registration date:2013-11-26, 1392/09/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-26, 1392/09/05
Registrant information
Name
Soheila Alyasin
Name of organization / entity
Shiraz University of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4298
Email address
alyasins@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of specific-antibody formation in response to pneumococcal vaccination in children with systemic lupus erythematosus, and asthmatic control group, at Shiraz Namazi hospital and Imam Reza clinic
Public title
immunogenicity of pneumococcal vaccine in children with systemic lupus erythematosus
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria of case group: 2-18 years old; SLE disease
exclusion criteria of case group: fever; recent immunization; history of previous pneumococcal vaccination; history of hypersensitivity reaction to vaccination; platelet level less than 50,000 ; mixed connective tissue disorders; IVIG injection in last 3 months.
inclusion criteria of control group: 2-18 years old; mild asthma
exclusion criteria of control group: fever; recent immunization; history of previous pneumococcal vaccination; history of hypersensitivity reaction to vaccination; platelet level less than 50,000 ; mixed connective tissue disorders; IVIG injection in last 3 months; patients with persistent or severe asthma; patients with history of immunosuppressive therapy or PO corticosteroid consumption; patient with history of other immunodeficiency disorders
Age
From 2 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
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
Shiraz University of Medical Science
Street address
Research department, Shiraz University of Medical Science, Shiraz, Fars.
City
Shiraz
Postal code
Approval date
2012-02-09, 1390/11/20
Ethics committee reference number
CT-P-90-2963
Health conditions studied
1
Description of health condition studied
systemic lupus erythematosus (SLE)
ICD-10 code
M32
ICD-10 code description
Systemic lupus erythematosus
Primary outcomes
1
Description
speific anti-pneumococcal antibody
Timepoint
before vaccination and 3 weeks after intervention
Method of measurement
using enzyme linked immunoassay kit specific for pneumococcal vaccine (ELISA)
2
Description
lupus activity
Timepoint
before vaccination and 3 weeks after intervention
Method of measurement
according to SLE disease activity index (SLEDAI)
Secondary outcomes
1
Description
SLE activity
Timepoint
before vaccination and 3 weeks after intervention
Method of measurement
according to SLE disease activity index
Intervention groups
1
Description
patients with SLE as case group were referred to Imam Reza immunology clinic and at baseline a complete history-taking and physical examination was done. Informed consent was obtained from all participants or their parents. Before vaccination 5 cc venous blood sample was taken and then each participant received 0.5 ml intradeltoid injection of 23-valent pneumococcal vaccine (pneumovax-23; Sanofi Pasteur MSD). After vaccinations patients were observed at clinic for 30 minute by rheumatologist and adverse effects such as severe local swelling and redness, fever or weakness were recorded.At least 3 weeks after vaccination, the patients were visited at immunology clinic again and history-taking, physical exam and disease activity scoring was done again and their post-vaccination lab data were recorded in their questionnaires. Then again 5cc venous blood sampling was done. Both pre-vaccination and post-vaccination serum samples of all participants were sent to Allergy research center of Shiraz and anti-pneumococcal specific IgG titer was measured using ELISA. Antibody (IgG) response were analyzed with enzyme linked immunoassay kit specific for pneumococcal vaccine .
Category
Prevention
2
Description
patients with asthma as control group were referred to Imam Reza immunology clinic. Informed consent was obtained from all participants or their parents. Before vaccination 5 cc venous blood sample was taken and then each participant received 0.5 ml intradeltoid injection of 23-valent pneumococcal vaccine (pneumovax-23; Sanofi Pasteur MSD). After vaccinations patients were observed at clinic for 30 minute by rheumatologist and adverse effects such as severe local swelling and redness, fever or weakness were recorded.At least 3 weeks after vaccination, the patients were visited at immunology clinic and 5cc venous blood sampling was done again. Both pre-vaccination and post-vaccination serum samples of all participants were sent to Allergy research center of Shiraz and anti-pneumococcal specific IgG titer was measured using ELISA. Antibody (IgG) response were analyzed with enzyme linked immunoassay kit specific for pneumococcal vaccine .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazee Hospital of Shiraz
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Imam Reza Clinic of Shiraz
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Gholamreza Hatam
Street address
Research department, Shiraz University of Medical Science, Shiraz, Fars.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Science
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
Shiraz University of Medical Science
Full name of responsible person
Dr.Soheila Alyasin
Position
Associate Professor of Pediatrics, Pediatric Immunology and Allergy specialist
Other areas of specialty/work
Street address
Devision of immunology and allergy, Department of Pediatric, Shiraz University of Medical Sciences, Namazee Hospital, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1647 4298
Fax
Email
alyasins@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr.Soheila Alyasin
Position
Associate Professor of Pediatrics, Pediatric Immunology and Allergy specialist
Other areas of specialty/work
Street address
Devision of immunology and allergy, Department of Pediatric, Shiraz University of Medical Sciences, Namazee Hospital, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 64 74298
Fax
Email
alyasins@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr.Soheila Alyasin
Position
Associate Professor of Pediatrics, Pediatric Immunology and Allergy specialist
Other areas of specialty/work
Street address
Devision of immunology and allergy, Department of Pediatric, Shiraz University of Medical Sciences, Namazee Hospital, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 64 74298
Fax
Email
alyasins@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)