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Vaccine. 2017 Sep 5;35(37):4877-4885. doi: 10.1016/j.vaccine.2017.07.094. Epub 2017 Aug 4.

Pneumococcal vaccination in patients with systemic lupus erythematosus: A multicenter placebo-controlled randomized double-blind study.

Author information

1
Université 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.
2
Université Paris Descartes, Sorbonne Paris Cité AP-HP, Service de Médecine Interne, Centre de Référence National pour les Maladies Auto-Immunes Rares (Vascularites et Sclérodermie Systémique), Paris, France.
3
Université Paris Descartes, Sorbonne Paris Cité AP-HP, Département d'Immunologie Biologique, Groupe Hospitalier Cochin Broca Hôtel-Dieu, Paris, France.
4
Université Pierre et Marie Curie, Sorbonne Paris Cité AP-HP, Service de Médecine Interne 2, Centre de Référence National pour le Lupus et le Syndrome des Antiphospholipides, institut E3M, Paris, France.
5
Université Versailles Saint-Quentin-en-Yvelines, APHP, Service de Médecine Interne, Hôpital Ambroise Paré, Boulogne-Billancourt, France.
6
Inserm, CIC 1417, Paris, France; Université Paris Descartes, Sorbonne Paris Cité AP-HP, Groupe Hospitalier Cochin Broca Hôtel-Dieu, Fédération d'Infectiologie, Paris, France; Inserm, F-CRIN I-REIVAC, France. Electronic address: odile.launay@aphp.fr.

Abstract

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.

KEYWORDS:

Conjugate pneumococcal vaccine; Immunosuppression; Pneumococcal polysaccharide vaccine; Systemic lupus erythematosus

PMID:
28784280
DOI:
10.1016/j.vaccine.2017.07.094
[Indexed for MEDLINE]

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