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).

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.

SUBMITTER: Butler C 

PROVIDER: S-EPMC8402379 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature