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  • Journal article
    Culley F, Swieboda D, Guo Y, Thwaites R, Nadel S, Openshaw Pet al.,

    A 14-color, 16-antibody panel for immunophenotyping human innate lymphoid, myeloid and T cells in small volumes of whole blood and pediatric airway samples

    , Cytometry Part A, ISSN: 1552-4949
  • Journal article
    Davies JC, Drevinek P, Elborn JS, Kerem E, Lee T, European CF Society ECFS Strategic Planning Task Force on Speeding up access to new 4 drugs for CF, Amaral MD, de Boeck K, Davies JC, Drevinek P, Elborn JS, Kerem E, Lee Tet al., 2019,

    Speeding up access to new drugs for CF: Considerations for clinical trial design and delivery

    , Journal of Cystic Fibrosis, Vol: 18, Pages: 677-684, ISSN: 1569-1993

    The last decade has witnessed developments in the CF drug pipeline which are both exciting and unprecedented, bringing with them previously unconsidered challenges. The Task Force group was brought together to consider these challenges and possible strategies to address them. Over the last 18 months, we have discussed internally and gathered views from a broad range of individuals representing patient organisations, clinical and research teams, the pharmaceutical industry and regulatory agencies. In this and the accompanying article, we discuss two main areas of focus: i) optimising trial design and delivery for speed and efficiency; ii) drug development for patients with rare CFTR mutations. We propose some strategies to tackle the challenges ahead and highlight areas where further thought is needed. We see this as the start of a process rather than the end and hope herewith to engage the wider community in seeking solutions to improved treatments for all patients with CF.

  • Journal article
    Davies JC, Scott S, Dobra R, Brendell R, Brownlee K, Carr SB, Cosgriff R, Simmonds NJ, London Network of Clinical Trials Accelerator Platform sites, Jahan R, Jones A, Matthews J, Brown S, Galono K, Miles K, Pao C, Shafi N, Watson D, Orchard C, Davies G, Pike K, Shah S, Bossley CJ, Fong T, Macedo P, Ruiz G, Waller M, Baker Let al., 2019,

    Fair selection of participants in clinical trials: The challenge to push the envelope further

    , Journal of Cystic Fibrosis, Vol: 18, Pages: e48-e50, ISSN: 1569-1993
  • Journal article
    Kirsebom FCM, Kausar F, Nuriev R, Makris S, Johansson Cet al., 2019,

    Neutrophil recruitment and activation are differentially dependent on MyD88/TRIF and MAVS signaling during RSV infection

    , Mucosal Immunology, Vol: 12, Pages: 1244-1255, ISSN: 1933-0219

    Respiratory syncytial virus (RSV) is a leading cause of severe lower respiratory tract infections, especially in infants. Lung neutrophilia is a hallmark of RSV disease but the mechanism by which neutrophils are recruited and activated is unclear. Here, we investigate the innate immune signaling pathways underlying neutrophil recruitment and activation in RSV-infected mice. We show that MyD88/TRIF signaling is essential for lung neutrophil recruitment while MAVS signaling, leading to type I IFN production, is necessary for neutrophil activation. Consistent with that notion, administration of type I IFNs to the lungs of RSV-infected Mavs-/- mice partially activates lung neutrophils recruited via the MyD88/TRIF pathway. Conversely, lack of neutrophil recruitment to the lungs of RSV-infected Myd88/Trif-/- mice can be reversed by administration of chemoattractants and those neutrophils become fully activated. Interestingly, Myd88/Trif-/- mice did not have increased lung RSV loads during infection, suggesting that neutrophils are dispensable for control of the virus. Thus, two distinct pathogen sensing pathways collaborate for neutrophil recruitment and full activation during RSV infection.

  • Journal article
    Ascough S, Vlachantoni I, Kalyan M, Haijema B-J, Wallin-Weber S, Dijkstra-Tiekstra M, Ahmed MS, van Roosmalen M, Grimaldi R, Zhang Q, Leenhouts K, Openshaw PJ, Chiu C, Ascough S, Vlachantoni I, Kalyan M, Haijema BJ, Wallin-Weber S, Dijkstra-Tiekstra M, Ahmed MS, van Roosmalen M, Grimaldi R, Zhang Q, Leenhouts K, Openshaw P, Chiu Cet al., 2019,

    Local and systemic immunity against RSV induced by a novel intranasal vaccine: A randomised, double- blind, placebo-controlled trial

    , American Journal of Respiratory and Critical Care Medicine, Vol: 200, Pages: 481-492, ISSN: 1073-449X

    RATIONALE: Needle-free intranasal vaccines offer major potential advantages, especially against pathogens entering via mucosal surfaces. As yet, there is no effective vaccine against respiratory syncytial virus (RSV), a ubiquitous pathogen of global importance that preferentially infects respiratory epithelial cells; new strategies are urgently required. OBJECTIVES: Here, we report the safety and immunogenicity of a novel mucosal RSV F protein vaccine linked to an immunostimulatory bacterium-like particle (BLP). METHODS: In this phase I, randomised, double-blind placebo-controlled trial, 48 healthy volunteers aged 18-49 years were randomly assigned to receive placebo or SynGEM (low- or high-dose) intranasally by prime-boost administration. The primary outcome was safety and tolerability, with secondary objectives assessing virus-specific immunogenicity. MEASUREMENTS AND MAIN RESULTS: There were no significant differences in adverse events between placebo and vaccinated groups. SynGEM induced systemic plasmablast responses and significant, durable increases in RSV-specific serum antibody in healthy seropositive adults. Volunteers given low-dose SynGEM (140 µg F, 2mg BLP) required a boost at day 28 to achieve plateau responses with a maximum fold-change of 2.4, whereas high-dose recipients (350 µg F, 5mg BLP) achieved plateau responses with a fold-change of 1.5 after first vaccination that remained elevated up to 180 days post-vaccination irrespective of further boosting. Palivizumab-like antibodies were consistently induced, but F protein site Ø-specific antibodies were not detected and virus-specific nasal IgA responses were heterogeneous, with strongest responses in individuals with lower pre-existing antibody levels. CONCLUSIONS: SynGEM is thus the first non-replicating intranasal RSV subunit vaccine to induce persistent antibody responses in human volunteers. Clinical trial registration available at www.clinicaltrials.gov, ID NCT02958540.

  • Journal article
    Li Y, Reeves RM, Wang X, Bassat Q, Brooks WA, Cohen C, Moore DP, Nunes M, Rath B, Campbell H, Nair H, Acacio S, Alonso WJ, Antonio M, Ayora Talavera G, Badarch D, Baillie VL, Barrera-Badillo G, Bigogo G, Broor S, Bruden D, Buchy P, Byass P, Chipeta J, Clara W, Dang D-A, de Freitas Lazaro Emediato CC, de Jong M, Diaz-Quinonez JA, Do LAH, Fasce RA, Feng L, Ferson MJ, Gentile A, Gessner BD, Goswami D, Goyet S, Grijalva CG, Halasa N, Hellferscee O, Hessong D, Homaira N, Jara J, Kahn K, Khuri-Bulos N, Kotloff KL, Lanata CF, Lopez O, Lopez Bolanos MR, Lucero MG, Lucion F, Lupisan SP, Madhi SA, McCracken JP, Mekgoe O, Moraleda C, Moyes J, Mulholland K, Munywoki PK, Naby F, Thanh HN, Nicol MP, Nokes DJ, Noyola DE, Onozuka D, Palani N, Poovorawan Y, Rahman M, Ramaekers K, Romero C, Schlaudecker EP, Schweiger B, Seidenberg P, Simoes EAF, Singleton R, Sistla S, Sturm-Ramirez K, Suntronwong N, Sutanto A, Tapia MD, Thamthitiwat S, Thongpan I, Tillekeratne G, Tinoco YO, Treurnicht FK, Turner C, Turner P, van Doorn R, Van Ranst M, Visseaux B, Waicharoen S, Wang J, Yoshida L-M, Zar HJ, Shi T, Zhang S, Openshaw P, Wedzicha J, Falsey A, Miller M, Beutels P, Bont L, Pollard A, Molero E, Martinon-Torres F, Heikkinen T, Meijer A, Fischer TK, van den Berge M, Giaquinto C, Mikolajczyk R, Hackett J, Dillon L, Tafesse E, Cai B, Knirsch C, Lopez AG, Dieussaert I, Dermateau N, Leach A, Stoszek SK, Gallichan S, Kieffer A, Demont C, Denouel A, Cheret A, Gavart S, Aerssens J, Wyffels V, Cleenewerck M, Fuentes R, Rosen Bet al., 2019,

    Global patterns in monthly activity of influenza virus, respiratory syncytial virus, parainfluenza virus, and metapneumovirus: a systematic analysis

    , LANCET GLOBAL HEALTH, Vol: 7, Pages: E1031-E1045, ISSN: 2214-109X
  • Journal article
    Davies JC, 2019,

    Trials and tribulations: The highs and lows of running cystic fibrosis drug studies

    , PAEDIATRIC RESPIRATORY REVIEWS, Vol: 31, Pages: 25-27, ISSN: 1526-0542
  • Journal article
    Dobra R, Madge S, Martin I, Weldon P, Simmonds N, Davies JCet al., 2019,

    "Fortunate are those who take the first steps"? The psychosocial impact of novel drug development.

    , Paediatric Respiratory Reviews, Vol: 31, Pages: 9-11, ISSN: 1526-0542

    Novel drug development offers people with cystic fibrosis exciting opportunities but is not without challenges. Currently, there is an understandable emphasis on protecting patients' physical health when developing treatments. However, there appears to be little consideration of how novel drug development impacts on psychosocial wellbeing, or the downstream consequences of this. Using an illustrative case and reviewing the literature we explore themes regarding the psychosocial impact of trial participation and novel drug development and identify areas requiring further research. Through this, we hope to prepare healthcare professionals to better understand the needs of their patients in this rapidly evolving landscape.

  • Journal article
    Progatzky F, Jha A, Wane M, Thwaites RS, Makris S, Shattock RJ, Johansson C, Openshaw PJ, Bugeon L, Hansel TT, Dallman MJet al., 2019,

    Induction of innate cytokine responses by respiratory mucosal challenge with R848 in zebrafish, mice and humans

    , Journal of Allergy and Clinical Immunology, Vol: 144, Pages: 342-345.e7, ISSN: 0091-6749

    We compared live zebrafish, mouse and human nasal challenge responses to the TLR7/8 agonist resiquimod (R848). We found remarkably similar induction of mediators in the three species, offering novel mucosal models of innate anti-viral immunity.

  • Conference paper
    Palau H, Meng C, Bhargava A, Pilou A, Atsumi N, Byrne A, Pringle I, Ashworth R, Chan M, Gill D, Hyde S, Morgan C, Alton E, Griesenbach Uet al., 2019,

    Lentivirus Gene Therapy for Autoimmune Pulmonary Alveolar Proteinosis

    , 22nd Annual Meeting of the American-Society-of-Gene-and-Cell-Therapy (ASGCT), Publisher: CELL PRESS, Pages: 43-44, ISSN: 1525-0016

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