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A study to determine the effectiveness of the pneumococcal vaccine in patients of systemic lupus erythematosus.

Pneumococcal vaccination in SLE: Review of evidence, estimation of immunogenicity and cost-effectiveness analysis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027331
Enrollment
100
Registered
2020-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement

Interventions

Intervention1: Pneumovax 23: 23 valent pneumococcal polysaccharide vaccine. Single dose 0.5ml given Intramuscular. Control Intervention1: Not applicable: Not applicable

Sponsors

Sanjay gandhi Post Graduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of SLE on a stable dose of immunosuppression(no increase in glucocorticoid dose or change in other immunosuppressive agents) in the past 3 months.

Exclusion criteria

Exclusion criteria: 1. History of allergy to a vaccine component in the past. 2. History of having taken IV immunoglobulin in the past 3 months. 3. History of pneumococcal vaccination in the past 5 years. 4. History of any known immunodeficiency disorder.

Design outcomes

Primary

MeasureTime frame
Antibody titres in sera of patients to 7 of the 23 pneumococcal antigents.Timepoint: 6-12 weeks—

Secondary

MeasureTime frame
Number of flares of disease activity Autoantibody levels Timepoint: 6-12 weeks.—

Countries

India

Contacts

Public ContactRudrarpan Chatterjee

Sanjay gandhi Post Graduate Institute of Medical Sciences, Lucknow

aa.amita@gmail.com05222494284

Outcome results

None listed

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