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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT138811293361N1
Enrollment
60
Registered
2013-11-26
Start date
2013-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic lupus erythematosus (SLE). Systemic lupus erythematosus

Interventions

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
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.
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 partici
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 wa

Sponsors

Shiraz University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
SLE activity. Timepoint: before vaccination and 3 weeks after intervention. Method of measurement: according to SLE disease activity index.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Soheila Alyasin

Shiraz University of Medical Science

alyasins@sums.ac.ir+98 71 1647 4298

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026