tetano
Editor, Senior Moderator
Arthritis Rheum. 2011 Aug 2. doi: 10.1002/art.30576. [Epub ahead of print]
Factors influencing the efficacy of two injections of a pandemic 2009 influenza A (H1N1) non-adjuvanted vaccine in Systemic Lupus Erythematosus.
A M, Devilliers H, Krivine A, Costedoat-Chalumeau N, Haroche J, Boutin-Le Thi Huong D, Wechsler B, Hervier B, Miyara M, Morel N, Le Corre N, Arnaud L, Piette J, Musset L, Autran B, Rozenberg F, Amoura Z.
Source
Service de m?decine interne, Centre de R?f?rence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Piti?-Salp?tri?re, APHP, Paris, France; Universit? Pierre et Marie Curie, UPMC Univ Paris 06, Paris, France; INSERM UMR-S 945, immunit? et infection, Paris, France. alexis.mathian@psl.aphp.fr.
Abstract
OBJECTIVE:
To assess the factors influencing the efficacy of two injections of a pandemic 2009 influenza A (H1N1) vaccine in patients with Systemic Lupus Erythematosus (SLE).
METHODS:
we conducted an observational single-center prospective study. One hundred and eleven patients were vaccinated with a monovalent, inactivated, non-adjuvanted, split-virus vaccine during December 2009 and January 2010 and received a second dose of vaccine three weeks later. The antibody response was evaluated using the hemagglutination inhibition assay according to the guidelines recommended for the pandemic vaccine.
RESULTS:
The three immunogenicity criteria were met at day 42 [seroprotection rate was 80.0% (95%CI, 72.5-87.5%), seroconversion rate 71.8% (95%CI, 63.4-80.2%) and Geometric Mean Ratio (GMR) 10.3 (95%CI, 2.9-14.2)] while only two criteria were met at day 21 [seroprotection rate was 66.7% (95%CI, 57.9-75.4%), seroconversion rate 60.4% (95%CI, 51.3-69.5%) and GMR 8.5 (95%CI, 3.2-12.0)]. Vaccine was well tolerated. Disease activity, assessed by the SELENA-SLEDAI, the BILAG and the SLAQ scores, did not increase. In the multivariate analysis, vaccination failure was statistically associated with the use of an immunosuppressive treatment or a lymphocyte count ≤ 1.0 ? 10(9) /L. The second injection significantly increased the immunogenicity in these subgroups, but not high enough to fulfill the seroprotection criterion in patients with immunosuppressive treatment.
CONCLUSIONS:
Efficacy of the vaccine was impaired in patients on immunosuppressive drug or with lymphopenia. A second injection increased vaccine immunogenicity without reaching all efficacy criteria for a pandemic vaccine in patients with an immunosuppressive agent. These results open perspectives for improving anti-influenza vaccination in SLE.
Copyright ? 2011 by the American College of Rheumatology.
PMID:
21811996
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/21811996
Factors influencing the efficacy of two injections of a pandemic 2009 influenza A (H1N1) non-adjuvanted vaccine in Systemic Lupus Erythematosus.
A M, Devilliers H, Krivine A, Costedoat-Chalumeau N, Haroche J, Boutin-Le Thi Huong D, Wechsler B, Hervier B, Miyara M, Morel N, Le Corre N, Arnaud L, Piette J, Musset L, Autran B, Rozenberg F, Amoura Z.
Source
Service de m?decine interne, Centre de R?f?rence National pour les Lupus et le Syndrome des Antiphospholipides, Groupement Hospitalier Piti?-Salp?tri?re, APHP, Paris, France; Universit? Pierre et Marie Curie, UPMC Univ Paris 06, Paris, France; INSERM UMR-S 945, immunit? et infection, Paris, France. alexis.mathian@psl.aphp.fr.
Abstract
OBJECTIVE:
To assess the factors influencing the efficacy of two injections of a pandemic 2009 influenza A (H1N1) vaccine in patients with Systemic Lupus Erythematosus (SLE).
METHODS:
we conducted an observational single-center prospective study. One hundred and eleven patients were vaccinated with a monovalent, inactivated, non-adjuvanted, split-virus vaccine during December 2009 and January 2010 and received a second dose of vaccine three weeks later. The antibody response was evaluated using the hemagglutination inhibition assay according to the guidelines recommended for the pandemic vaccine.
RESULTS:
The three immunogenicity criteria were met at day 42 [seroprotection rate was 80.0% (95%CI, 72.5-87.5%), seroconversion rate 71.8% (95%CI, 63.4-80.2%) and Geometric Mean Ratio (GMR) 10.3 (95%CI, 2.9-14.2)] while only two criteria were met at day 21 [seroprotection rate was 66.7% (95%CI, 57.9-75.4%), seroconversion rate 60.4% (95%CI, 51.3-69.5%) and GMR 8.5 (95%CI, 3.2-12.0)]. Vaccine was well tolerated. Disease activity, assessed by the SELENA-SLEDAI, the BILAG and the SLAQ scores, did not increase. In the multivariate analysis, vaccination failure was statistically associated with the use of an immunosuppressive treatment or a lymphocyte count ≤ 1.0 ? 10(9) /L. The second injection significantly increased the immunogenicity in these subgroups, but not high enough to fulfill the seroprotection criterion in patients with immunosuppressive treatment.
CONCLUSIONS:
Efficacy of the vaccine was impaired in patients on immunosuppressive drug or with lymphopenia. A second injection increased vaccine immunogenicity without reaching all efficacy criteria for a pandemic vaccine in patients with an immunosuppressive agent. These results open perspectives for improving anti-influenza vaccination in SLE.
Copyright ? 2011 by the American College of Rheumatology.
PMID:
21811996
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/21811996