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Efficacy and Safety of a Modified Vaccinia Ankara-NP+M1 Vaccine Combined with QIV in People Aged 65 and Older: A Randomised Controlled Clinical Trial (INVICTUS)

Background: Pre-existing T cell responses to influenza have been correlated with improved clinical outcomes in natural history and human challenge studies. We aimed to determine the efficacy, safety and immunogenicity of a T-cell directed vaccine in older people. Methods: This was a multicentre, par...

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Autores principales: Butler, Chris, Ellis, Chris, Folegatti, Pedro M., Swayze, Hannah, Allen, Julie, Bussey, Louise, Bellamy, Duncan, Lawrie, Alison, Eagling-Vose, Elizabeth, Yu, Ly-Mee, Shanyinde, Milensu, Mair, Catherine, Flaxman, Amy, Ewer, Katie, Gilbert, Sarah, Evans, Thomas G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8402379/
https://www.ncbi.nlm.nih.gov/pubmed/34451976
http://dx.doi.org/10.3390/vaccines9080851
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author Butler, Chris
Ellis, Chris
Folegatti, Pedro M.
Swayze, Hannah
Allen, Julie
Bussey, Louise
Bellamy, Duncan
Lawrie, Alison
Eagling-Vose, Elizabeth
Yu, Ly-Mee
Shanyinde, Milensu
Mair, Catherine
Flaxman, Amy
Ewer, Katie
Gilbert, Sarah
Evans, Thomas G.
author_facet Butler, Chris
Ellis, Chris
Folegatti, Pedro M.
Swayze, Hannah
Allen, Julie
Bussey, Louise
Bellamy, Duncan
Lawrie, Alison
Eagling-Vose, Elizabeth
Yu, Ly-Mee
Shanyinde, Milensu
Mair, Catherine
Flaxman, Amy
Ewer, Katie
Gilbert, Sarah
Evans, Thomas G.
author_sort Butler, Chris
collection PubMed
description Background: Pre-existing T cell responses to influenza have been correlated with improved clinical outcomes in natural history and human challenge studies. We aimed to determine the efficacy, safety and immunogenicity of a T-cell directed vaccine in older people. Methods: This was a multicentre, participant- and safety assessor-blinded, randomised, placebo-controlled trial of the co-administration of Modified Vaccinia Ankara encoding nucleoprotein and matrix protein 1 (MVA-NP+M1) and annual influenza vaccine in participants ≥ 65. The primary outcome was the number of days with moderate or severe influenza-like symptoms (ILS) during the influenza season. Results: 846 of a planned 2030 participants were recruited in the UK prior to, and throughout, the 2017/18 flu season. There was no evidence of a difference in the reported rates of days of moderate or severe ILS during influenza-like illness episodes (unadjusted OR = 0.95, 95% CI: 0.54–1.69; adjusted OR = 0.91, 95% CI: 0.51–1.65). The trial was stopped after one season due to a change in the recommended annual flu vaccine, for which safety of the new combination had not been established. More participants in the MVA-NP+M1 group had transient moderate or severe pain, redness, and systemic responses in the first seven days. Conclusion: The MVA-NP+M1 vaccine is well tolerated in those aged 65 years and over. Larger trials would be needed to determine potential efficacy.
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spelling pubmed-84023792021-08-29 Efficacy and Safety of a Modified Vaccinia Ankara-NP+M1 Vaccine Combined with QIV in People Aged 65 and Older: A Randomised Controlled Clinical Trial (INVICTUS) Butler, Chris Ellis, Chris Folegatti, Pedro M. Swayze, Hannah Allen, Julie Bussey, Louise Bellamy, Duncan Lawrie, Alison Eagling-Vose, Elizabeth Yu, Ly-Mee Shanyinde, Milensu Mair, Catherine Flaxman, Amy Ewer, Katie Gilbert, Sarah Evans, Thomas G. Vaccines (Basel) Article Background: Pre-existing T cell responses to influenza have been correlated with improved clinical outcomes in natural history and human challenge studies. We aimed to determine the efficacy, safety and immunogenicity of a T-cell directed vaccine in older people. Methods: This was a multicentre, participant- and safety assessor-blinded, randomised, placebo-controlled trial of the co-administration of Modified Vaccinia Ankara encoding nucleoprotein and matrix protein 1 (MVA-NP+M1) and annual influenza vaccine in participants ≥ 65. The primary outcome was the number of days with moderate or severe influenza-like symptoms (ILS) during the influenza season. Results: 846 of a planned 2030 participants were recruited in the UK prior to, and throughout, the 2017/18 flu season. There was no evidence of a difference in the reported rates of days of moderate or severe ILS during influenza-like illness episodes (unadjusted OR = 0.95, 95% CI: 0.54–1.69; adjusted OR = 0.91, 95% CI: 0.51–1.65). The trial was stopped after one season due to a change in the recommended annual flu vaccine, for which safety of the new combination had not been established. More participants in the MVA-NP+M1 group had transient moderate or severe pain, redness, and systemic responses in the first seven days. Conclusion: The MVA-NP+M1 vaccine is well tolerated in those aged 65 years and over. Larger trials would be needed to determine potential efficacy. MDPI 2021-08-03 /pmc/articles/PMC8402379/ /pubmed/34451976 http://dx.doi.org/10.3390/vaccines9080851 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/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 (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Butler, Chris
Ellis, Chris
Folegatti, Pedro M.
Swayze, Hannah
Allen, Julie
Bussey, Louise
Bellamy, Duncan
Lawrie, Alison
Eagling-Vose, Elizabeth
Yu, Ly-Mee
Shanyinde, Milensu
Mair, Catherine
Flaxman, Amy
Ewer, Katie
Gilbert, Sarah
Evans, Thomas G.
Efficacy and Safety of a Modified Vaccinia Ankara-NP+M1 Vaccine Combined with QIV in People Aged 65 and Older: A Randomised Controlled Clinical Trial (INVICTUS)
title Efficacy and Safety of a Modified Vaccinia Ankara-NP+M1 Vaccine Combined with QIV in People Aged 65 and Older: A Randomised Controlled Clinical Trial (INVICTUS)
title_full Efficacy and Safety of a Modified Vaccinia Ankara-NP+M1 Vaccine Combined with QIV in People Aged 65 and Older: A Randomised Controlled Clinical Trial (INVICTUS)
title_fullStr Efficacy and Safety of a Modified Vaccinia Ankara-NP+M1 Vaccine Combined with QIV in People Aged 65 and Older: A Randomised Controlled Clinical Trial (INVICTUS)
title_full_unstemmed Efficacy and Safety of a Modified Vaccinia Ankara-NP+M1 Vaccine Combined with QIV in People Aged 65 and Older: A Randomised Controlled Clinical Trial (INVICTUS)
title_short Efficacy and Safety of a Modified Vaccinia Ankara-NP+M1 Vaccine Combined with QIV in People Aged 65 and Older: A Randomised Controlled Clinical Trial (INVICTUS)
title_sort efficacy and safety of a modified vaccinia ankara-np+m1 vaccine combined with qiv in people aged 65 and older: a randomised controlled clinical trial (invictus)
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8402379/
https://www.ncbi.nlm.nih.gov/pubmed/34451976
http://dx.doi.org/10.3390/vaccines9080851
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