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Immunogenicity and Reactogenicity of 2009 Influenza A (H1N1) Inactivated Monovalent Non-Adjuvanted Vaccine in Elderly and Immunocompromised Patients

2011; Public Library of Science; Volume: 6; Issue: 11 Linguagem: Inglês

10.1371/journal.pone.0027214

ISSN

1932-6203

Autores

João Luiz Miraglia, Edson Abdala, Paulo M. Hoff, André Machado Luiz, Danise Senna Oliveira, Carla Gonçalves Schahin Saad, Iêda Maria Magalhães Laurindo, Ana Teresa Rodriguez Viso, Ângela Tayra, Lı́gia Camera Pierrotti, Luiz Sérgio Azevedo, Lúcia Maria Arruda Campos, Nádia Emi Aikawa, María do Carmo Sampaio Tavares Timenetsky, Expedito José de Albuquerque Luna, Maria Regina Alves Cardoso, José da Silva Guedes, Isaı́as Raw, Jorge Kalil, Alexander Roberto Precioso,

Tópico(s)

Monoclonal and Polyclonal Antibodies Research

Resumo

Background Immunosuppressed individuals present serious morbidity and mortality from influenza, therefore it is important to understand the safety and immunogenicity of influenza vaccination among them. Methods This multicenter cohort study evaluated the immunogenicity and reactogenicity of an inactivated, monovalent, non-adjuvanted pandemic (H1N1) 2009 vaccine among the elderly, HIV-infected, rheumatoid arthritis (RA), cancer, kidney transplant, and juvenile idiopathic arthritis (JIA) patients. Participants were included during routine clinical visits, and vaccinated according to conventional influenza vaccination schedules. Antibody response was measured by the hemagglutination-inhibition assay, before and 21 days after vaccination. Results 319 patients with cancer, 260 with RA, 256 HIV-infected, 149 elderly individuals, 85 kidney transplant recipients, and 83 with JIA were included. The proportions of seroprotection, seroconversion, and the geometric mean titer ratios postvaccination were, respectively: 37.6%, 31.8%, and 3.2 among kidney transplant recipients, 61.5%, 53.1%, and 7.5 among RA patients, 63.1%, 55.7%, and 5.7 among the elderly, 59.0%, 54.7%, and 5.9 among HIV-infected patients, 52.4%, 49.2%, and 5.3 among cancer patients, 85.5%, 78.3%, and 16.5 among JIA patients. The vaccine was well tolerated, with no reported severe adverse events. Conclusions The vaccine was safe among all groups, with an acceptable immunogenicity among the elderly and JIA patients, however new vaccination strategies should be explored to improve the immune response of immunocompromised adult patients. (ClinicalTrials.gov, NCT01218685)

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