Immunogenicity and safety of a respiratory syncytial virus fusion protein (RSV F) nanoparticle vaccine in older adults
Autor: | Somia P. Hickman, Louis Fries, Gale Smith, Vivek Shinde, Eloi Kpamegan, Pedro A. Piedra, D. Nigel Thomas, Jeffrey J. Stoddard, Gregory M. Glenn, Hanxin Lu |
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Rok vydání: | 2017 |
Předmět: |
lcsh:Immunologic diseases. Allergy
0301 basic medicine Trivalent influenza vaccine Aging medicine.medical_treatment Immunology lcsh:Geriatrics medicine.disease_cause Avidity F or fusion protein 03 medical and health sciences 0302 clinical medicine Immunity Palivizumab-competitive antibody (PCA) medicine 030212 general & internal medicine Anti-F IgG Cardiopulmonary disease Microneutralization Recombinant business.industry Immunogenicity Research Nanoparticle vaccine Virology Vaccination lcsh:RC952-954.6 030104 developmental biology Respiratory syncytial virus (RSV) lcsh:RC581-607 business Adjuvant |
Zdroj: | Immunity & Ageing : I & A Immunity & Ageing, Vol 14, Iss 1, Pp 1-14 (2017) |
ISSN: | 1742-4933 |
Popis: | Background A preventative strategy for Respiratory Syncytial Virus (RSV) infection constitutes an under-recognized unmet medical need among older adults. Four formulations of a novel recombinant RSV F nanoparticle vaccine (60 or 90 μg RSV F protein, with or without aluminum phosphate adjuvant) administered concurrently with a licensed inactivated trivalent influenza vaccine (TIV) in older adult subjects were evaluated for safety and immunogenicity in this randomized, observer-blinded study. Results A total of 220 healthy males and females ≥ 60 years of age, without symptomatic cardiopulmonary disease, were vaccinated concurrently with TIV and RSV F vaccine or placebo. All vaccine formulations produced an acceptable safety profile, with no vaccine-related serious adverse events or evidence of systemic toxicity. Vaccine-induced immune responses were rapid, rising as early as 7 days post-vaccination; and were comparable in all formulations in terms of magnitude, with maximal levels attained within 28 (unadjuvanted) or 56 (adjuvanted) days post-vaccination. Peak anti-F protein IgG antibody levels rose 3.6- to 5.6-fold, with an adjuvant effect observed at the 60 μg dose, and a dose-effect observed between the unadjuvanted 60 and 90 μg regimens. The anti-F response persisted through 12 months post-vaccination. Palivizumab-competitive antibodies were below quantifiable levels ( |
Databáze: | OpenAIRE |
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