Vaccination of patients with mild and severe asthma with a 2009 pandemic H1N1 influenza virus vaccine - 10/08/11
, Stephen P. Peters, MD, PhD b, Matthew J. Fenton, PhD c, Herman Mitchell, PhD d, Eugene R. Bleecker, MD b, Mario Castro, MD, MPH e, Sally Wenzel, MD f, Serpil C. Erzurum, MD g, Anne M. Fitzpatrick, PhD h, W. Gerald Teague, MD i, Nizar Jarjour, MD a, Wendy C. Moore, MD b, Kaharu Sumino, MD, PhD e, Scott Simeone, MA f, Suphagaphan Ratanamaneechat, MD g, Madhuri Penugonda, MD h, Benjamin Gaston, MD i, Ted M. Ross, PhD j, Steve Sigelman, RN c, Joella R. Schiepan, MPH, MCRP d, Daniel J. Zaccaro, MS d, Corey J. Crevar, BS, MBA j, Donald M. Carter, BS, MS j, Alkis Togias, MD c
Reprint requests: William W. Busse, MD, University of Wisconsin Hospital and Clinics, K4/910 CSC, MC 9988, 600 Highland Ave, Madison WI 53792.Abstract |
Background |
Asthma was the most common comorbidity of patients hospitalized with 2009 H1N1 influenza.
Objective |
We sought to assess the immunogenicity and safety of an unadjuvanted, inactivated 2009 H1N1 vaccine in patients with severe versus mild-to-moderate asthma.
Methods |
We conducted an open-label study involving 390 participants (age, 12-79 years) enrolled in October-November 2009. Severe asthma was defined as need for 880 μg/d or more of inhaled fluticasone equivalent, systemic corticosteroids, or both. Within each severity group, participants were randomized to receive intramuscularly 15 or 30 μg of 2009 H1N1 vaccine twice 21 days apart. Immunogenicity end points were seroprotection (hemagglutination inhibition assay titer ≥40) and seroconversion (4-fold or greater titer increase). Safety was assessed through local and systemic reactogenicity, asthma exacerbations, and pulmonary function.
Results |
In patients with mild-to-moderate asthma (n = 217), the 2009 H1N1 vaccine provided equal seroprotection 21 days after the first immunization at the 15-μg (90.6%; 95% CI, 83.5% to 95.4%) and 30-μg (95.3%; 95% CI, 89.4% to 98.5%) doses. In patients with severe asthma (n = 173), seroprotection 21 days after the first immunization was 77.9% (95% CI, 67.7% to 86.1%) and 94.1% (95% CI, 86.8% to 98.1%) at the 15- and 30-μg doses, respectively (P = .004). The second vaccination did not provide further increases in seroprotection. Participants with severe asthma who are older than 60 years showed the lowest seroprotection (44.4% at day 21) with the 15-μg dose but had adequate seroprotection with 30 μg. The 2 dose groups did not differ in seroconversion rates. There were no safety concerns.
Conclusion |
Monovalent inactivated 2009 H1N1 pandemic influenza vaccine was safe and provided overall seroprotection as a surrogate of efficacy. In patients older than 60 years with severe asthma, a 30-μg dose might be more appropriate.
Le texte complet de cet article est disponible en PDF.Key words : H1N1, asthma, influenza, vaccine, seroprotection, severe asthma
Abbreviations used : FVC, GMT, HAI, ICS, SAE, TIV
Plan
| The names of the institutions and investigators who collaborated in the H1N1 vaccination study are shown in Appendix E1 in the Online Respository at www.jacionline.org. |
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| Funding for this study was provided by the US National Institutes of Health (NIH) through a supplement contribution from the National Institute of Allergy and Infectious Diseases (NIAID) to the National Heart, Lung, and Blood Institute (NHLBI)–funded grant 3 R01 HL069116-09S1. Rho, Inc, the Data and Statistical Coordinating Center for this study, was funded by NIAID contract number NO1-AI-25482. Additional funds were provided by the NIH Research Project grants RO1 HL69170 and HL081064 and by the National Center for Research Resources under grants 1UL1RR024989 and UL1RR025008. NIAID and NHLBI scientists and project managers were involved in the design of the study and the writing of the protocol, as well as in study medical monitoring, data analysis, and manuscript preparation. Vaccine was purchased from Novartis Vaccines and Diagnostics Ltd by the US Government BioMedical Advanced Research and Development Authority (BARDA), which coordinated the 2009 H1N1 pandemic influenza vaccination in the United Sates. BARDA had no other role in this study. |
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| Disclosure of potential conflict of interest: W. W. Busse is on advisory boards for Altair, Amgen, Centocor, GlaxoSmithKline, Merck, Pfizer, Wyeth, and Johnson & Johnson; has consultant arrangements with AstraZeneca, Boehringer Ingelheim, Novartis, TEVA, and GlaxoSmithKline; is a speaker for Merck; and receives research support from Novartis, AstraZeneca, GlaxoSmithKline, MedImmune, Ception, the National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID), and the NIH/National Heart, Lung, and Blood Institute (NHLBI). S. P. Peters receives research support from the NIH/NHLBI and Novartis. H. Mitchell receives research support from the NIH. E. R. Bleecker receives research support from the NIH/NHLBI and Novartis. M. Castro has consultant arrangements with Electrocore, NKTT, Schering-Plough, Asthmatx, and Cephalon; is on the advisory board for Genentech; is a speaker for AstraZeneca, Boehringer Ingelheim, Pfizer, Merck, and GlaxoSmithKline; has received institutional grant support from Asthmatx, Amgen, Ception, Genentech, MedImmune, Merck, Novartis, the NIH, and GlaxoSmithKline; has received royalties from Elsevier; and has received research support from the NIH. W. G. Teague is a speaker for Merck and receives research support from the NIH. N. Jarjour has consultant arrangements with Asthmatx and Genentech; receives research support from GlaxoSmithKline, MedImmune, and Genentech; and receives honoraria from Merck. W. C. Moore receives research support from the NHLBI. K. Sumino receives research support from the NIH and the VA. B. Gaston receives research support from the NIH. J. R. Schiepan receives research support from the NIH. The rest of the authors have declared that they have no conflict of interest. |
Vol 127 - N° 1
P. 130 - janvier 2011 Retour au numéro
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