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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...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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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. |
format | Online Article Text |
id | pubmed-8402379 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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