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- 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).
- Authors
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.
- Abstract
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.
- Subjects
UNITED Kingdom; CLINICAL trials; RANDOMIZED controlled trials; OLDER people; VACCINIA; INFLUENZA vaccines
- Publication
Vaccines, 2021, Vol 9, Issue 8, p851
- ISSN
2076-393X
- Publication type
Article
- DOI
10.3390/vaccines9080851