FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4220793885> ?p ?o ?g. }

• W4220793885 endingPage "866" @default.
• W4220793885 startingPage "857" @default.
• W4220793885 abstract "In animal, epidemiological, and human challenge studies, a pre-existing T-cell response to internal proteins of influenza A has been associated with improved virological and disease outcomes. The aim of this study was to assess whether inducing additional responses to conserved CD4 and CD8 T-cell antigens provides added benefit to standard influenza vaccination.We designed a phase 2b, randomised, placebo-controlled, double-blind trial of a recombinant viral-vectored vaccine (modified vaccinia Ankara expressing virus nucleoprotein and matrix protein 1; MVA-NP+M1), which has been shown to induce both CD4 and CD8 T cells, at eight outpatient clinical trial sites in Australia over two consecutive influenza seasons. We recruited non-immunosuppressed adults (≥18 years) who had received the 2019 quadrivalent influenza vaccine (QIV) vaccine within 28 days before study enrolment and randomisation (day 0). Participants were randomly assigned (1:1) according to a computer-generated random sequence to receive one dose of 1·5 × 108 plaque-forming units of MVA-NP+M1 or saline (placebo) intramuscularly. Randomisation was stratified by age (<65 years or ≥65 years). The patients and trial assessors were masked to treatment assignment. During the subsequent influenza seasons, participants with symptoms related to respiratory illness or influenza-like illness were to attend the clinic within 72 h of symptom onset for two nasal swabs for influenza testing by quantitative RT-PCR. The primary endpoint was the incidence rate of laboratory-confirmed influenza in the intention-to-treat (ITT) population. Safety (solicited adverse events within 7 days and unsolicited adverse events within 28 days after study vaccination, and serious adverse events for the study duration) was assessed in all randomly assigned participants who received at least one vaccination (according to the treatment received). The trial is registered with ClinicalTrials.gov, NCT03880474.Between April 2 and June 14, 2019, 2152 adults were randomly allocated and received MVA-NP+M1 (n=1077) or placebo (n=1075), comprising the efficacy (ITT) analysis set. Participants were followed up throughout the 2019 Australia influenza season (May 1 to Oct 15, 2019). 419 (19·5%) of 2152 participants were aged 65 years or older. The incidence of laboratory-confirmed influenza did not differ between the MVA-NP+M1 group (35 of 1077 participants; 3·25% [95% CI 2·31-4·44]) and the placebo group (23 of 1075; 2·14% [1·39-3·14]; Fisher's exact p=0·14). 23 severe solicited local injection site reactions were reported in 13 (0·6%) of 2152 participants, 22 of which were reported in the MVA-NP + M1 group (in 12 [1·1%] participants). 100 severe systemic events were reported in 45 (4·2%) MVA-NP + M1 recipients, and 20 were reported in 14 (1·3%) placebo recipients. Three unsolicited grade 3 events in three participants (two headache and one nausea, all in the MVA-NP+M1 group) were deemed vaccine related. 21 serious adverse events were reported in 18 (1·7%) of 1077 participants in the MVA-NP+M1 group and 25 serious adverse events were reported in 22 (2·0%) of 1075 participants in the placebo group; none were considered vaccine related. The trial was stopped after one season for futility on the recommendation of the data monitoring committee.MVA-NP+M1 was well tolerated with no vaccine-associated serious adverse events. A vaccine designed to induce moderate T-cell responses to the cross-reactive internal proteins of influenza A did not lead to improved incidence when given within 28 days after standard QIV immunisation. A greater magnitude of T-cell response with a different vaccine or regimen, or localisation in the lungs via alternative delivery, such as intranasal or aerosol, might be successful and require further investigation.Vaccitech." @default.
• W4220793885 created "2022-04-03" @default.
• W4220793885 creator A5012821937 @default.
• W4220793885 creator A5025987579 @default.
• W4220793885 creator A5033973551 @default.
• W4220793885 creator A5039424103 @default.
• W4220793885 creator A5044269137 @default.
• W4220793885 creator A5045555853 @default.
• W4220793885 creator A5047315777 @default.
• W4220793885 creator A5053619122 @default.
• W4220793885 creator A5057807377 @default.
• W4220793885 creator A5061283831 @default.
• W4220793885 creator A5064780677 @default.
• W4220793885 creator A5068247012 @default.
• W4220793885 creator A5072065006 @default.
• W4220793885 creator A5081371818 @default.
• W4220793885 creator A5084524299 @default.
• W4220793885 creator A5087210662 @default.
• W4220793885 date "2022-06-01" @default.
• W4220793885 modified "2023-10-16" @default.
• W4220793885 title "Efficacy and safety of a universal influenza A vaccine (MVA-NP+M1) in adults when given after seasonal quadrivalent influenza vaccine immunisation (FLU009): a phase 2b, randomised, double-blind trial" @default.
• W4220793885 cites W1811768630 @default.
• W4220793885 cites W1936124037 @default.
• W4220793885 cites W1970569268 @default.
• W4220793885 cites W2001187841 @default.
• W4220793885 cites W2005362030 @default.
• W4220793885 cites W2033561913 @default.
• W4220793885 cites W2036182565 @default.
• W4220793885 cites W2038281342 @default.
• W4220793885 cites W2038286384 @default.
• W4220793885 cites W2039622221 @default.
• W4220793885 cites W2065461284 @default.
• W4220793885 cites W2066717808 @default.
• W4220793885 cites W2072546058 @default.
• W4220793885 cites W2076787697 @default.
• W4220793885 cites W2095408086 @default.
• W4220793885 cites W2098337510 @default.
• W4220793885 cites W2105225614 @default.
• W4220793885 cites W2105898497 @default.
• W4220793885 cites W2106799126 @default.
• W4220793885 cites W2117655206 @default.
• W4220793885 cites W2132287875 @default.
• W4220793885 cites W2139699918 @default.
• W4220793885 cites W2150788554 @default.
• W4220793885 cites W2151026229 @default.
• W4220793885 cites W2329310459 @default.
• W4220793885 cites W2396545278 @default.
• W4220793885 cites W2473001391 @default.
• W4220793885 cites W2566527653 @default.
• W4220793885 cites W2592394892 @default.
• W4220793885 cites W2782484059 @default.
• W4220793885 cites W2790577051 @default.
• W4220793885 cites W2892654499 @default.
• W4220793885 cites W2923307084 @default.
• W4220793885 cites W3036887998 @default.
• W4220793885 cites W3187523027 @default.
• W4220793885 doi "https://doi.org/10.1016/s1473-3099(21)00702-7" @default.
• W4220793885 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/35305317" @default.
• W4220793885 hasPublicationYear "2022" @default.
• W4220793885 type Work @default.
• W4220793885 citedByCount "15" @default.
• W4220793885 countsByYear W42207938852022 @default.
• W4220793885 countsByYear W42207938852023 @default.
• W4220793885 crossrefType "journal-article" @default.
• W4220793885 hasAuthorship W4220793885A5012821937 @default.
• W4220793885 hasAuthorship W4220793885A5025987579 @default.
• W4220793885 hasAuthorship W4220793885A5033973551 @default.
• W4220793885 hasAuthorship W4220793885A5039424103 @default.
• W4220793885 hasAuthorship W4220793885A5044269137 @default.
• W4220793885 hasAuthorship W4220793885A5045555853 @default.
• W4220793885 hasAuthorship W4220793885A5047315777 @default.
• W4220793885 hasAuthorship W4220793885A5053619122 @default.
• W4220793885 hasAuthorship W4220793885A5057807377 @default.
• W4220793885 hasAuthorship W4220793885A5061283831 @default.
• W4220793885 hasAuthorship W4220793885A5064780677 @default.
• W4220793885 hasAuthorship W4220793885A5068247012 @default.
• W4220793885 hasAuthorship W4220793885A5072065006 @default.
• W4220793885 hasAuthorship W4220793885A5081371818 @default.
• W4220793885 hasAuthorship W4220793885A5084524299 @default.
• W4220793885 hasAuthorship W4220793885A5087210662 @default.
• W4220793885 hasConcept C120665830 @default.
• W4220793885 hasConcept C121332964 @default.
• W4220793885 hasConcept C126322002 @default.
• W4220793885 hasConcept C142724271 @default.
• W4220793885 hasConcept C159047783 @default.
• W4220793885 hasConcept C168563851 @default.
• W4220793885 hasConcept C187212893 @default.
• W4220793885 hasConcept C197934379 @default.
• W4220793885 hasConcept C203014093 @default.
• W4220793885 hasConcept C203092338 @default.
• W4220793885 hasConcept C204787440 @default.
• W4220793885 hasConcept C22070199 @default.
• W4220793885 hasConcept C27081682 @default.
• W4220793885 hasConcept C2780689484 @default.
• W4220793885 hasConcept C2908647359 @default.
• W4220793885 hasConcept C61511704 @default.
• W4220793885 hasConcept C71924100 @default.
• W4220793885 hasConcept C99454951 @default.

• next