Pneumococcal vaccination in patients with systemic lupus erythematosus: A multicenter placebo-controlled randomized
Sophie Grabar1, Matthieu Groh2, Mathilde Bahuaud3
1Université Paris Descartes, Sorbonne Paris Cité AP-HP, Unité de Biostatistique et Epidémiologie, Groupe Hospitalier Cochin Broca Hôtel-Dieu, Paris, France; INSERM, UPMC Université Paris 06, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136), F75013 Paris, France.
Background:
Invasive pneumococcal disease and respiratory tract infections are both frequent and severe in patients with systemic lupus erythematosus (SLE). This study aimed to compare the immunological efficacy and safety of pneumococcal vaccination with the 23-valent polysaccharide (PPS) vaccine alone to a sequential immunization with the 7-valent pneumococcal conjugate (PnCj) vaccine followed by PPS in patients with SLE and stable diseaase.
Methods:
Multicenter randomized placebo-controlled double-blind trial: PPS vaccine alone (placebo-PPS group) or PnCj vaccine followed by PPS vaccine (PnCj-PPS group) 24weeks later. The primary endpoint was the rate of responders at week 28 to at least 5 of the 7 serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) shared by both PPS and PnCj. Pneumococcal IgG antibodies' opsonophagocytic activity (OPA) were also assessed.
Results:
Twenty-five patients in the placebo-PPS group and 17 in the PnCj-PPS group were included in a modified intention-to-treat analysis. The primary endpoint was reached in 72% (18/25) in the placebo-PPS and 76% (13/17) in the PnCj-PPS group (p=0.75). There was no difference in the rates of responders with OPA. At week 52, 13/18 (72%) patients in the placebo-PPS group and 10/13 (77%) patients in the PnCj-PPS group (p=0.77) that met the primary endpoint at week 28 were still responders to ≥5/7 serotypes shared by both PPS and PnCj vaccines. Nine SLE flares were reported in 6 patients (4 in the placebo-PPS and 2 in the PnCj-PPS groups respectively, p=0.70).
Conclusion:
Sequential administration of PnCj vaccine followed by PPS vaccine is safe and shows short-term immunological efficacy in patients with SLE but was not superior to the PPS vaccine alone.
Trial Registration:
www.clinicaltrials.gov, NCT NCT00611663.
Related Concept Videos
01:27Chronic Obstructive Pulmonary Disease-IV: Assessement and Diagnostic Studies
Medical History
01:30Pneumonia III: Complications and Assessment
01:29Chronic Obstructive Pulmonary Disease-V: Management
Smoking Cessation
01:24Chronic Obstructive Pulmonary Disease
Smoking is a primary risk factor for COPD, with over 80% of patients having a history of it. Patients typically experience progressive dyspnea or labored breathing, frequent coughing, and recurrent pulmonary infections. Many eventually succumb to respiratory failure, characterized by...
01:30Pneumonia V: Nursing management and Prevention
The nurse must practice strict medical asepsis and adhere to infection control guidelines to minimize healthcare-associated infections.
Enhance airway patency
Position the patient correctly to facilitate drainage of the affected lung segments. Manual or mechanical percussion and vibration can also be employed....
01:51Vaccinations