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

Abstract

BackgroundImmunosuppressed individuals present serious morbidity and mortality from influenza, therefore it is important to understand the safety and immunogenicity of influenza vaccination among them.MethodsThis 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.Results319 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.ConclusionsThe 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)

Seroconversion of 2009 pandemic influenza A (H1N1) vaccination in kidney transplant patients and the influence of different risk factors

“…Seroprotection (HI titers ≥1:40) was achieved in 32 of 85 (37.6%) patients (5 patients with prevaccine HI titers ≥1:40 and 27 seroconverted patients). A low rate of seroprotection has also been reported in non‐transplanted immunosuppressed populations, such as patients with malignancy, rheumatic diseases, and HIV .…”

“…This study is a separated arm of this cited broader multicenter study , from which only the renal transplanted population was selected. This was an open, prospective study, and it was approved by the Ethics Committee of our Institution (CAPPESQ 0171/10).…”

“…The seroconversion of the 2009 pandemic influenza A (H1N1) – A(H1N1)pdm09 – vaccine, administered from March to August 2010, was studied in a large population of Brazilian patients with many immunological deficiencies secondary to kidney transplants, cancer, human immunodeficiency virus (HIV), rheumatoid arthritis, juvenile idiopathic arthritis, and in elderly people (>60 years of age). The results showed the following seroconversion rates in previously negative patients: 80% (juvenile arthritis), 56.9% (elderly), 53.8% (HIV), 53.9% (rheumatoid arthritis), 48.6% (cancer), and 33.8% (kidney transplant) . In that study, our center included all 85 kidney transplanted patients.…”

Immune reconstitution and vaccination outcome in HIV-1 infected children

“…84,85 However, the rate of consequences due to natural A(H1N1) infection was similar between HIV-1 infected subjects and healthy controls and the efficacy of diverse formulations of influenza vaccines (with or without different adjuvants coupled to the influenza antigens) in both adults and children, was reported in several studies. [86][87][88][89] Nonetheless, the numerous studies undergone during the A(H1N1) pandemic represented a great occasion for increasing the knowledge on immunological undetectable HIV-1 viral load and high CD4 + T-cell counts but treated later in time. 36 Altogether, this suggests that early HIV-1 suppression may help preserving the ability of T-and B-cells to respond to DTP in HIV-1 infected children.…”

Vaccination in Rheumatology: Current Aspects

“…В частности, в ходе много-центрового когортного исследования показатели серопро-текции, сероконверсии и фактора конверсии после имму-низации инактивированной моновалентной пандемиче-ской (H1N1) противогриппозной вакциной составили со-ответственно 61,5%; 53,1% и 7,5 среди 260 больных РА и 85,5%, 78,3% и 16,5 в группе из 83 пациентов с ювениль-ным идиопатическим артритом. Переносимость вакцина-ции была хорошей, серьезных нежелательных реакиций (НР) не наблюдали [23].…”