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)
<br><strong>Background: </strong>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 peopl...
| Main Authors: | , , , , , , , , , , , , |
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| Other Authors: | |
| Format: | Journal article |
| Language: | English |
| Published: |
MDPI
2021
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| _version_ | 1826260935388430336 |
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| author | Butler, C Ellis, C Folegatti, P Swayze, H Allen, J Lawrie, A Yu, L Shanyinde, M Bellamy, D Mair, C Flaxman, A Ewer, KJ Gilbert, S |
| author2 | INVICTUS Investigators |
| author_facet | INVICTUS Investigators Butler, C Ellis, C Folegatti, P Swayze, H Allen, J Lawrie, A Yu, L Shanyinde, M Bellamy, D Mair, C Flaxman, A Ewer, KJ Gilbert, S |
| author_sort | Butler, C |
| collection | OXFORD |
| description | <br><strong>Background: </strong>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.
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Methods: </strong>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.
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Results: </strong>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.
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Conclusion:</strong> The MVA-NP+M1 vaccine is well tolerated in those aged 65 years and over. Larger trials would be needed to determine potential efficacy. |
| first_indexed | 2024-03-06T19:13:37Z |
| format | Journal article |
| id | oxford-uuid:179be801-bc33-449c-baa7-e55cbac8c809 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T19:13:37Z |
| publishDate | 2021 |
| publisher | MDPI |
| record_format | dspace |
| spelling | oxford-uuid:179be801-bc33-449c-baa7-e55cbac8c8092022-03-26T10:38:25ZEfficacy 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)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:179be801-bc33-449c-baa7-e55cbac8c809EnglishSymplectic ElementsMDPI2021Butler, CEllis, CFolegatti, PSwayze, HAllen, JLawrie, AYu, LShanyinde, MBellamy, DMair, CFlaxman, AEwer, KJGilbert, SINVICTUS Investigators<br><strong>Background: </strong>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. <br><strong> Methods: </strong>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. <br><strong> Results: </strong>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. <br><strong> Conclusion:</strong> The MVA-NP+M1 vaccine is well tolerated in those aged 65 years and over. Larger trials would be needed to determine potential efficacy. |
| spellingShingle | Butler, C Ellis, C Folegatti, P Swayze, H Allen, J Lawrie, A Yu, L Shanyinde, M Bellamy, D Mair, C Flaxman, A Ewer, KJ Gilbert, S 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 |
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