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A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above (INVICTUS): a study protocol
Seasonal influenza has a significant annual global impact. Current influenza vaccines work by inducing strain-specific antibodies against the highly polymorphic surface proteins of the influenza virus and need to be redesigned every year, increasing their cost and limiting availability. There is a d...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
F1000 Research Limited
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7014788/ https://www.ncbi.nlm.nih.gov/pubmed/32089822 http://dx.doi.org/10.12688/f1000research.19090.1 |
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author | Swayze, Hannah Allen, Julie Folegatti, Pedro Yu, Ly-Mee Gilbert, Sarah Hill, Adrian Ellis, Chris Butler, Christopher C. |
author_facet | Swayze, Hannah Allen, Julie Folegatti, Pedro Yu, Ly-Mee Gilbert, Sarah Hill, Adrian Ellis, Chris Butler, Christopher C. |
author_sort | Swayze, Hannah |
collection | PubMed |
description | Seasonal influenza has a significant annual global impact. Current influenza vaccines work by inducing strain-specific antibodies against the highly polymorphic surface proteins of the influenza virus and need to be redesigned every year, increasing their cost and limiting availability. There is a demand for a more efficacious vaccine, particularly in older adults in which the current vaccines show poor efficacy. The aim is to investigate a novel vaccine, MVA-NP+M1, which targets T cell responses to the nucleoprotein and matrix 1 core proteins of the influenza virus A, which are highly conserved, and therefore may provide long protection against a broad range of influenza strains. INVICTUS is a phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above is a randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study planned for 2030 volunteers aged 65 and over, in primary care. The primary objective is to assess the efficacy of MVA-NP+M1 co-administered with licensed inactivated quadrivalent influenza vaccine in adults ≥65 years. Participants complete daily diaries to record solicited and unsolicited events in the first four weeks post vaccination, and influenza-like illness (ILI) symptoms and severity throughout the influenza season. We hypothesise an improvement in the primary outcome, a reduction in the average number of days spent with moderate or severe influenza-like illness during periods of influenza circulation, in the group administered with MVA-NP+M1, compared to those in the control group. Registration: ClinicalTrials.gov identifier NCT03300362. Protocol version: INVICTUS Protocol v3.0, 08 June06 2018. |
format | Online Article Text |
id | pubmed-7014788 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | F1000 Research Limited |
record_format | MEDLINE/PubMed |
spelling | pubmed-70147882020-02-20 A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above (INVICTUS): a study protocol Swayze, Hannah Allen, Julie Folegatti, Pedro Yu, Ly-Mee Gilbert, Sarah Hill, Adrian Ellis, Chris Butler, Christopher C. F1000Res Study Protocol Seasonal influenza has a significant annual global impact. Current influenza vaccines work by inducing strain-specific antibodies against the highly polymorphic surface proteins of the influenza virus and need to be redesigned every year, increasing their cost and limiting availability. There is a demand for a more efficacious vaccine, particularly in older adults in which the current vaccines show poor efficacy. The aim is to investigate a novel vaccine, MVA-NP+M1, which targets T cell responses to the nucleoprotein and matrix 1 core proteins of the influenza virus A, which are highly conserved, and therefore may provide long protection against a broad range of influenza strains. INVICTUS is a phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above is a randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study planned for 2030 volunteers aged 65 and over, in primary care. The primary objective is to assess the efficacy of MVA-NP+M1 co-administered with licensed inactivated quadrivalent influenza vaccine in adults ≥65 years. Participants complete daily diaries to record solicited and unsolicited events in the first four weeks post vaccination, and influenza-like illness (ILI) symptoms and severity throughout the influenza season. We hypothesise an improvement in the primary outcome, a reduction in the average number of days spent with moderate or severe influenza-like illness during periods of influenza circulation, in the group administered with MVA-NP+M1, compared to those in the control group. Registration: ClinicalTrials.gov identifier NCT03300362. Protocol version: INVICTUS Protocol v3.0, 08 June06 2018. F1000 Research Limited 2019-05-23 /pmc/articles/PMC7014788/ /pubmed/32089822 http://dx.doi.org/10.12688/f1000research.19090.1 Text en Copyright: © 2019 Swayze H et al. http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Swayze, Hannah Allen, Julie Folegatti, Pedro Yu, Ly-Mee Gilbert, Sarah Hill, Adrian Ellis, Chris Butler, Christopher C. A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed Ina CTivated infl Uenza vaccine in adult S aged 65 years and above (INVICTUS): a study protocol |
title | A phase IIb study to determine the safety and efficacy of candidate
INfluenza
Vaccine MVA-NP+M1 in combination with licensed
Ina
CTivated infl
Uenza vaccine in adult
S aged 65 years and above (INVICTUS): a study protocol |
title_full | A phase IIb study to determine the safety and efficacy of candidate
INfluenza
Vaccine MVA-NP+M1 in combination with licensed
Ina
CTivated infl
Uenza vaccine in adult
S aged 65 years and above (INVICTUS): a study protocol |
title_fullStr | A phase IIb study to determine the safety and efficacy of candidate
INfluenza
Vaccine MVA-NP+M1 in combination with licensed
Ina
CTivated infl
Uenza vaccine in adult
S aged 65 years and above (INVICTUS): a study protocol |
title_full_unstemmed | A phase IIb study to determine the safety and efficacy of candidate
INfluenza
Vaccine MVA-NP+M1 in combination with licensed
Ina
CTivated infl
Uenza vaccine in adult
S aged 65 years and above (INVICTUS): a study protocol |
title_short | A phase IIb study to determine the safety and efficacy of candidate
INfluenza
Vaccine MVA-NP+M1 in combination with licensed
Ina
CTivated infl
Uenza vaccine in adult
S aged 65 years and above (INVICTUS): a study protocol |
title_sort | phase iib study to determine the safety and efficacy of candidate
influenza
vaccine mva-np+m1 in combination with licensed
ina
ctivated infl
uenza vaccine in adult
s aged 65 years and above (invictus): a study protocol |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7014788/ https://www.ncbi.nlm.nih.gov/pubmed/32089822 http://dx.doi.org/10.12688/f1000research.19090.1 |
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