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A Randomized Controlled Study to Evaluate the Safety and Reactogenicity of a Novel rVLP-Based Plant Virus Nanoparticle Adjuvant Combined with Seasonal Trivalent Influenza Vaccine Following Single Immunization in Healthy Adults 18–50 Years of Age

Inactivated influenza vaccines efficacy is variable and often poor. We conducted a phase 1 trial (NCT02188810), to assess the safety and immunogenicity of a novel nanoparticle Toll-like receptor 7/8 agonist adjuvant (Papaya Mosaic Virus) at different dose levels combined with trivalent influenza vac...

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Autores principales: Langley, Joanne, Pastural, Elodie, Halperin, Scott, McNeil, Shelly, ElSherif, May, MacKinnon-Cameron, Donna, Ye, Lingyun, Grange, Cécile, Thibodeau, Valérie, Cailhier, Jean-François, Lapointe, Rejean, McElhaney, Janet, Martin, Luis, Bolduc, Marilène, Laliberté-Gagné, Marie-Eve, Leclerc, Denis, Savard, Pierre
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564144/
https://www.ncbi.nlm.nih.gov/pubmed/32698532
http://dx.doi.org/10.3390/vaccines8030393
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author Langley, Joanne
Pastural, Elodie
Halperin, Scott
McNeil, Shelly
ElSherif, May
MacKinnon-Cameron, Donna
Ye, Lingyun
Grange, Cécile
Thibodeau, Valérie
Cailhier, Jean-François
Lapointe, Rejean
McElhaney, Janet
Martin, Luis
Bolduc, Marilène
Laliberté-Gagné, Marie-Eve
Leclerc, Denis
Savard, Pierre
author_facet Langley, Joanne
Pastural, Elodie
Halperin, Scott
McNeil, Shelly
ElSherif, May
MacKinnon-Cameron, Donna
Ye, Lingyun
Grange, Cécile
Thibodeau, Valérie
Cailhier, Jean-François
Lapointe, Rejean
McElhaney, Janet
Martin, Luis
Bolduc, Marilène
Laliberté-Gagné, Marie-Eve
Leclerc, Denis
Savard, Pierre
author_sort Langley, Joanne
collection PubMed
description Inactivated influenza vaccines efficacy is variable and often poor. We conducted a phase 1 trial (NCT02188810), to assess the safety and immunogenicity of a novel nanoparticle Toll-like receptor 7/8 agonist adjuvant (Papaya Mosaic Virus) at different dose levels combined with trivalent influenza vaccine in healthy persons 18–50 years of age. Hemagglutination-inhibition assays, antibody to Influenza A virus nucleoprotein and peripheral blood mononuclear cells for measurement of interferon-gamma ELISPOT response to influenza antigens, Granzyme B and IFNγ:IL-10 ratio were measured. The most common adverse events were transient mild to severe injection site pain and no safety signals were observed. A dose-related adjuvant effect was observed. Geometric mean hemagglutination-inhibition titers increased at day 28 in most groups and waned over time, but fold-antibody responses were poor in all groups. Cell mediated immunity results were consistent with humoral responses. The Papaya Mosaic Virus adjuvant in doses of 30 to 240 µg combined with reduced influenza antigen content was safe with no signals up to 3 years after vaccination. A dose-related adjuvant effect was observed and immunogenicity results suggest that efficacy study should be conducted in influenza antigen-naïve participants.
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spelling pubmed-75641442020-10-26 A Randomized Controlled Study to Evaluate the Safety and Reactogenicity of a Novel rVLP-Based Plant Virus Nanoparticle Adjuvant Combined with Seasonal Trivalent Influenza Vaccine Following Single Immunization in Healthy Adults 18–50 Years of Age Langley, Joanne Pastural, Elodie Halperin, Scott McNeil, Shelly ElSherif, May MacKinnon-Cameron, Donna Ye, Lingyun Grange, Cécile Thibodeau, Valérie Cailhier, Jean-François Lapointe, Rejean McElhaney, Janet Martin, Luis Bolduc, Marilène Laliberté-Gagné, Marie-Eve Leclerc, Denis Savard, Pierre Vaccines (Basel) Article Inactivated influenza vaccines efficacy is variable and often poor. We conducted a phase 1 trial (NCT02188810), to assess the safety and immunogenicity of a novel nanoparticle Toll-like receptor 7/8 agonist adjuvant (Papaya Mosaic Virus) at different dose levels combined with trivalent influenza vaccine in healthy persons 18–50 years of age. Hemagglutination-inhibition assays, antibody to Influenza A virus nucleoprotein and peripheral blood mononuclear cells for measurement of interferon-gamma ELISPOT response to influenza antigens, Granzyme B and IFNγ:IL-10 ratio were measured. The most common adverse events were transient mild to severe injection site pain and no safety signals were observed. A dose-related adjuvant effect was observed. Geometric mean hemagglutination-inhibition titers increased at day 28 in most groups and waned over time, but fold-antibody responses were poor in all groups. Cell mediated immunity results were consistent with humoral responses. The Papaya Mosaic Virus adjuvant in doses of 30 to 240 µg combined with reduced influenza antigen content was safe with no signals up to 3 years after vaccination. A dose-related adjuvant effect was observed and immunogenicity results suggest that efficacy study should be conducted in influenza antigen-naïve participants. MDPI 2020-07-20 /pmc/articles/PMC7564144/ /pubmed/32698532 http://dx.doi.org/10.3390/vaccines8030393 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Langley, Joanne
Pastural, Elodie
Halperin, Scott
McNeil, Shelly
ElSherif, May
MacKinnon-Cameron, Donna
Ye, Lingyun
Grange, Cécile
Thibodeau, Valérie
Cailhier, Jean-François
Lapointe, Rejean
McElhaney, Janet
Martin, Luis
Bolduc, Marilène
Laliberté-Gagné, Marie-Eve
Leclerc, Denis
Savard, Pierre
A Randomized Controlled Study to Evaluate the Safety and Reactogenicity of a Novel rVLP-Based Plant Virus Nanoparticle Adjuvant Combined with Seasonal Trivalent Influenza Vaccine Following Single Immunization in Healthy Adults 18–50 Years of Age
title A Randomized Controlled Study to Evaluate the Safety and Reactogenicity of a Novel rVLP-Based Plant Virus Nanoparticle Adjuvant Combined with Seasonal Trivalent Influenza Vaccine Following Single Immunization in Healthy Adults 18–50 Years of Age
title_full A Randomized Controlled Study to Evaluate the Safety and Reactogenicity of a Novel rVLP-Based Plant Virus Nanoparticle Adjuvant Combined with Seasonal Trivalent Influenza Vaccine Following Single Immunization in Healthy Adults 18–50 Years of Age
title_fullStr A Randomized Controlled Study to Evaluate the Safety and Reactogenicity of a Novel rVLP-Based Plant Virus Nanoparticle Adjuvant Combined with Seasonal Trivalent Influenza Vaccine Following Single Immunization in Healthy Adults 18–50 Years of Age
title_full_unstemmed A Randomized Controlled Study to Evaluate the Safety and Reactogenicity of a Novel rVLP-Based Plant Virus Nanoparticle Adjuvant Combined with Seasonal Trivalent Influenza Vaccine Following Single Immunization in Healthy Adults 18–50 Years of Age
title_short A Randomized Controlled Study to Evaluate the Safety and Reactogenicity of a Novel rVLP-Based Plant Virus Nanoparticle Adjuvant Combined with Seasonal Trivalent Influenza Vaccine Following Single Immunization in Healthy Adults 18–50 Years of Age
title_sort randomized controlled study to evaluate the safety and reactogenicity of a novel rvlp-based plant virus nanoparticle adjuvant combined with seasonal trivalent influenza vaccine following single immunization in healthy adults 18–50 years of age
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564144/
https://www.ncbi.nlm.nih.gov/pubmed/32698532
http://dx.doi.org/10.3390/vaccines8030393
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