{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:09:12Z","timestamp":1772168952061,"version":"3.50.1"},"reference-count":10,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2019,5,23]],"date-time":"2019-05-23T00:00:00Z","timestamp":1558569600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Vaccitech Limited"}],"content-domain":{"domain":["f1000research.com"],"crossmark-restriction":false},"short-container-title":["F1000Res"],"abstract":"\n 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,\n \u00a0<\/ns4:bold>\n and therefore may provide long protection against a broad range of influenza strains.\n <\/ns4:p>\n \n INVICTUS is a phase IIb study to determine the safety and efficacy of candidate\n IN<\/ns4:underline>\n fluenza\n V<\/ns4:underline>\n accine MVA-NP+M1 in combination with licensed\n I<\/ns4:underline>\n na\n CT<\/ns4:underline>\n ivated infl\n U<\/ns4:underline>\n enza vaccine in adult\n S<\/ns4:underline>\n 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 \u226565 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.\n <\/ns4:p>\n 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.<\/ns4:p>\n \n Registration:<\/ns4:bold>\n ClinicalTrials.gov identifier\n NCT03300362<\/ns4:ext-link>\n .\n <\/ns4:p>\n \n Protocol version:<\/ns4:bold>\n INVICTUS Protocol v3.0, 08 June06 2018.\n <\/ns4:p>","DOI":"10.12688\/f1000research.19090.1","type":"journal-article","created":{"date-parts":[[2019,5,23]],"date-time":"2019-05-23T07:00:07Z","timestamp":1558594807000},"page":"719","update-policy":"https:\/\/doi.org\/10.12688\/f1000research.crossmark-policy","source":"Crossref","is-referenced-by-count":14,"title":["A phase IIb study to determine the safety and efficacy of candidate INfluenza Vaccine MVA-NP+M1 in combination with licensed InaCTivated inflUenza vaccine in adultS aged 65 years and above (INVICTUS): a study protocol"],"prefix":"10.12688","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6509-3437","authenticated-orcid":false,"given":"Hannah","family":"Swayze","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie","family":"Allen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pedro","family":"Folegatti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ly-Mee","family":"Yu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6823-9750","authenticated-orcid":false,"given":"Sarah","family":"Gilbert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrian","family":"Hill","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris","family":"Ellis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher C.","family":"Butler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2019,5,23]]},"reference":[{"key":"ref-1","article-title":"Influenza","year":"2014"},{"key":"ref-2","doi-asserted-by":"publisher","first-page":"5086-96","DOI":"10.1016\/j.vaccine.2007.03.046","article-title":"The annual impact of seasonal influenza in the US: measuring disease burden and costs.","volume":"25","author":"N Molinari","year":"2007","journal-title":"Vaccine."},{"key":"ref-3","first-page":"65-78","article-title":"Influenza virus A (H5N1): a pandemic risk?","volume":"30","author":"M Babakir-Mina","year":"2007","journal-title":"New Microbiol."},{"key":"ref-4","doi-asserted-by":"publisher","first-page":"66","DOI":"10.1186\/1472-6963-7-66","article-title":"Influenza vaccine supply, 2005-2006: did we come up short?","volume":"7","author":"B Bardenheier","year":"2007","journal-title":"BMC Health Serv Res."},{"key":"ref-5","doi-asserted-by":"publisher","first-page":"133-8","DOI":"10.1016\/j.virusres.2004.02.025","article-title":"Immunogenicity and protective efficacy of influenza vaccination.","volume":"103","author":"C Hannoun","year":"2004","journal-title":"Virus Res."},{"key":"ref-6","doi-asserted-by":"publisher","first-page":"1422-31","DOI":"10.1164\/rccm.201411-1988OC","article-title":"Natural T Cell-mediated Protection against Seasonal and Pandemic Influenza. Results of the Flu Watch Cohort Study.","volume":"191","author":"A Hayward","year":"2015","journal-title":"Am J Respir Crit Care Med."},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"1305-12","DOI":"10.1038\/nm.3350","article-title":"Cellular immune correlates of protection against symptomatic pandemic influenza.","volume":"19","author":"S Sridhar","year":"2013","journal-title":"Nat Med."},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"1-7","DOI":"10.1093\/cid\/ciq015","article-title":"Potent CD8+ T-cell immunogenicity in humans of a novel heterosubtypic influenza A vaccine, MVA-NP+M1.","volume":"52","author":"T Berthoud","year":"2011","journal-title":"Clin Infect Dis."},{"key":"ref-9","doi-asserted-by":"publisher","first-page":"19-25","DOI":"10.1093\/cid\/cis327","article-title":"Preliminary assessment of the efficacy of a T-cell-based influenza vaccine, MVA-NP+M1, in humans.","volume":"55","author":"P Lillie","year":"2012","journal-title":"Clin Infect Dis."},{"key":"ref-10","article-title":"F1000Research INVICTUS Protocol Manuscript","author":"H Swayze","year":"2019"}],"container-title":["F1000Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/f1000research.com\/articles\/8-719\/v1\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/f1000research.com\/articles\/8-719\/v1\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/f1000research.com\/articles\/8-719\/v1\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,2,11]],"date-time":"2020-02-11T06:10:13Z","timestamp":1581401413000},"score":1,"resource":{"primary":{"URL":"https:\/\/f1000research.com\/articles\/8-719\/v1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,5,23]]},"references-count":10,"URL":"https:\/\/doi.org\/10.12688\/f1000research.19090.1","relation":{"has-review":[{"id-type":"doi","id":"10.5256\/f1000research.20920.r51322","asserted-by":"subject"},{"id-type":"doi","id":"10.5256\/f1000research.20920.r53395","asserted-by":"subject"},{"id-type":"doi","id":"10.5256\/f1000research.20920.r54948","asserted-by":"subject"},{"id-type":"doi","id":"10.5256\/f1000research.20920.r51322","asserted-by":"object"},{"id-type":"doi","id":"10.5256\/f1000research.20920.r53395","asserted-by":"object"},{"id-type":"doi","id":"10.5256\/f1000research.20920.r54948","asserted-by":"object"}]},"ISSN":["2046-1402"],"issn-type":[{"value":"2046-1402","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,5,23]]},"assertion":[{"value":"Indexed","URL":"https:\/\/f1000research.com\/articles\/8-719\/v1#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.5256\/f1000research.20920.r53395, Tamar Ben-Yedidia, BiondVax Pharmaceuticals Ltd., Ness Ziona, Israel, 24 Sep 2019, version 1, indexed","URL":"https:\/\/f1000research.com\/articles\/8-719\/v1#referee-response-53395","order":0,"name":"referee-response-53395","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.20920.r54948, Xavier Saelens, Department of Biomedical Molecular Biology, Ghent University, Ghent, Belgium, 24 Jan 2020, version 1, indexed","URL":"https:\/\/f1000research.com\/articles\/8-719\/v1#referee-response-54948","order":1,"name":"referee-response-54948","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.20920.r51322, Rebecca J. Cox, Influenza Centre, Department of Clinical Science, University of Bergen, Bergen, Norway, 11 Feb 2020, version 1, indexed","URL":"https:\/\/f1000research.com\/articles\/8-719\/v1#referee-response-51322","order":2,"name":"referee-response-51322","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Vaccitech Ltd. funded the trial. The authors declare that no other grants were involved in supporting this work.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"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.","order":0,"name":"copyright-info","label":"Copyright"}]}}