Immunogenicity and reactogenicity of 2009 influenza A (H1N1) inactivated monovalent non-adjuvanted vaccine in elderly and immunocompromised patients

João L Miraglia, Edson Abdala, Paulo M Hoff, André M Luiz, Danise S Oliveira, Carla G S Saad, Ieda M M Laurindo, Ana T R Viso, Angela Tayra, Lígia C Pierrotti, Luiz S Azevedo, Lúcia Maria A Campos, Nádia E Aikawa, Maria do Carmo S T Timenetsky, Expedito Luna, Maria Regina A Cardoso, José da S Guedes, Isaias Raw, Jorge Kalil, Alexander R Precioso, João L Miraglia, Edson Abdala, Paulo M Hoff, André M Luiz, Danise S Oliveira, Carla G S Saad, Ieda M M Laurindo, Ana T R Viso, Angela Tayra, Lígia C Pierrotti, Luiz S Azevedo, Lúcia Maria A Campos, Nádia E Aikawa, Maria do Carmo S T Timenetsky, Expedito Luna, Maria Regina A Cardoso, José da S Guedes, Isaias Raw, Jorge Kalil, Alexander R Precioso

Abstract

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).

Conflict of interest statement

Competing Interests: JLM, JSG, IR, and ARP are employees of Fundação Butantan. JK is employee of Instituto Butantan. EL has received payment for consulting from Fundação Butantan. All other authors report no conflicts. This does not alter the authors' adherence to all the PLoS ONE policies on sharing data and materials.

Figures

Figure 1. Reverse Cumulative Distribution Curves for…
Figure 1. Reverse Cumulative Distribution Curves for Hemagglutination-Inhibition Antibodies Titers on Day 21 After Vaccination.
(A) In the entire study population and (B) Excluding participants with prevaccination HI titers ≥1∶40. The limit of detection was a titer of 1∶10. Titers are expressed as the reciprocal of the dilution.

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