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IRCT138811293361N1 IRCT 2013-11-26 Shiraz University of Medical Science immunogenicity of pneumococcal vaccine in children with systemic lupus erythematosus 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 2013-09-23 anticipated 60 Complete https://irct.ir/trial/3435 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention. N/A systemic lupus erythematosus (SLE). Intervention 1: 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 . Intervention 2: 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 .
public Dr.Soheila Alyasin
Devision of immunology and allergy, Department of Pediatric, Shiraz University of Medical Sciences, Namazee Hospital, Shiraz, Iran
Shiraz Iran (Islamic Republic of) +98 71 1647 4298 alyasins@sums.ac.ir Shiraz University of Medical Science scientific Dr.Soheila Alyasin
Devision of immunology and allergy, Department of Pediatric, Shiraz University of Medical Sciences, Namazee Hospital, Shiraz, Iran
Shiraz Iran (Islamic Republic of) +98 64 74298 alyasins@sums.ac.ir Shiraz University of Medical Science Iran (Islamic Republic of) Iran (Islamic Republic of) 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 2 years 18 years Both M32 Systemic lupus erythematosus Prevention Prevention 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 . 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 . 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). Lupus activity. Timepoint: before vaccination and 3 weeks after intervention. Method of measurement: according to SLE disease activity index (SLEDAI). SLE activity. Timepoint: before vaccination and 3 weeks after intervention. Method of measurement: according to SLE disease activity index. Shiraz University of Medical Science Approved 2012-02-09 Shiraz University of Medical Science Research department, Shiraz University of Medical Science, Shiraz, Fars. Shiraz Iran (Islamic Republic of)