Wehling M (2009) Assessing the translatability of drug projects: what needs to be scored to predict success? Nat Rev Drug Discov 8(7):541–546. https://doi.org/10.1038/nrd2898
Article CAS PubMed Google Scholar
Wendler A, Wehling M (2012) Translatability scoring in drug development: eight case studies. J Transl Med 10:39. https://doi.org/10.1186/1479-5876-10-39
Article CAS PubMed PubMed Central Google Scholar
Wehling M (2006) Translational medicine: can it really facilitate the transition of research “from bench to bedside”? Eur J Clin Pharmacol 62(2):91–95. https://doi.org/10.1007/s00228-005-0060-4
Cummings JL (2020) Translational scoring of candidate treatments for Alzheimer’s Disease: A systematic approach. Dement Geriatr Cogn Disord 490(1):22–37. https://doi.org/10.1159/000507569
Chen Y, Liu Q, Guo D (2020) Emerging coronaviruses: genome structure, replication, and pathogenesis. J Med Virol 92(4):418–423. https://doi.org/10.1002/jmv.25681
Article CAS PubMed PubMed Central Google Scholar
Wendler A, Wehling M (2017) Translatability score revisited: differentiation for distinct disease areas. J Transl Med 15(1):226. https://doi.org/10.1186/s12967-017-1329-y
Article PubMed PubMed Central Google Scholar
Ravindra NG, Alfajaro MM, Gasque V, Huston NC, Wan H, Szigeti-Buck K, Yasumoto Y, Greaney AM, Habet V, Chow RD, Chen JS, Wei J, Filler RB, Wang B, Wang G, Niklason LE, Montgomery RR, Eisenbarth SC, Chen S, Williams A, Iwasaki A, Horvath TL, Foxman EF, Pierce RW, Pyle AM, van Dijk D, Wilen CB (2021) Single-cell longitudinal analysis of SARS-CoV-2 infection in human airway epithelium identifies target cells, alterations in gene expression, and cell state changes. PLoS Biol 19(3):e3001143. https://doi.org/10.1371/journal.pbio.3001143
Pandamooz S, Jurek B, Meinung CP, Baharvand Z, Shahem-Abadi AS, Haerteis S, Miyan JA, Downing J, Dianatpour M, Borhani-Haghighi A, Salehi MS (2021) Experimental models of SARS-CoV-2 infection: possible platforms to study COVID-19 pathogenesis and potential treatments. Annu Rev Pharmacol Toxicol. https://doi.org/10.1146/annurev-pharmtox-121120-012309
Gerdts V, Wilson HL, Meurens F, van Drunen Littel-van den Hurk S, Wilson D, Walker S, Wheler C, Townsend H, Potter AA (2015) Large animal models for vaccine development and testing. Ilar J 56(1):53–62. https://doi.org/10.1093/ilar/ilv009
Article CAS PubMed Google Scholar
Singh PK, Kulsum U, Rufai SB, Mudliar SR, Singh S (2020) Mutations in SARS-CoV-2 leading to antigenic variations in spike protein: a challenge in vaccine development. J Lab Physicians 12(2):154–160. https://doi.org/10.1055/s-0040-1715790
Article CAS PubMed PubMed Central Google Scholar
Kyriakidis NC, Lopez-Cortes A, Gonzalez EV, Grimaldos AB, Prado EO (2021) SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates. NPJ Vaccines 6(1):28. https://doi.org/10.1038/s41541-021-00292-w
Article CAS PubMed PubMed Central Google Scholar
DATAtab Team (2023) DATAtab: online statistics calculator. DATAtab e.U. Graz, Austria. https://datatab.net. In: ed. DATAtab
Aldrich C, Leroux-Roels I, Huang KB, Bica MA, Loeliger E, Schoenborn-Kellenberger O, Walz L, Leroux-Roels G, von Sonnenburg F, Oostvogels L (2021) Proof-of-concept of a low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles in human volunteers: A phase 1 trial. Vaccine 39(8):1310–1318. https://doi.org/10.1016/j.vaccine.2020.12.070
Article CAS PubMed PubMed Central Google Scholar
Esprit A, de Mey W, Bahadur Shahi R, Thielemans K, Franceschini L, Breckpot K (2020) Neo-antigen mRNA vaccines. Vaccines (Basel) 8(4). https://doi.org/10.3390/vaccines8040776
Chen X, Yang J, Wang L, Liu B (2020) Personalized neoantigen vaccination with synthetic long peptides: recent advances and future perspectives. Theranostics 10(13):6011–6023. https://doi.org/10.7150/thno.38742
Article CAS PubMed PubMed Central Google Scholar
Jin P, Li J, Pan H, Wu Y, Zhu F (2021) Immunological surrogate endpoints of COVID-2019 vaccines: the evidence we have versus the evidence we need. Signal Transduct Target Ther 6(1):48. https://doi.org/10.1038/s41392-021-00481-y
Article CAS PubMed PubMed Central Google Scholar
Curevac, CureVac Final Data from Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV, Demonstrates Protection in Age Group of 18 to 60 https://www.curevac.com/wp-content/uploads/2021/06/20210630_PR_CV_Final-analysis-of-Phase-2b-3-clinical-trial-for-CVnCoV_EN_Final.pdf. Accessed 30 Jun 2021
Kremsner PG, Ahuad Guerrero RA, Arana-Arri E, Aroca Martinez GJ, Bonten M, Chandler R, Corral G, De Block EJL, Ecker L, Gabor JJ, Garcia Lopez CA, Gonzales L, Granados González MA, Gorini N, Grobusch MP, Hrabar AD, Junker H, Kimura A, Lanata CF, Lehmann C, Leroux-Roels I, Mann P, Martinez-Reséndez MF, Ochoa TJ, Poy CA, Reyes Fentanes MJ, Rivera Mejia LM, Ruiz Herrera VV, Sáez-Llorens X, Schönborn-Kellenberger O, Schunk M, Sierra Garcia A, Vergara I, Verstraeten T, Vico M, Oostvogels L (2022) Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial. Lancet Infect Dis 22(3):329–340. https://doi.org/10.1016/s1473-3099(21)00677-0
Article CAS PubMed Google Scholar
Andrews N, Stowe J, Kirsebom F, Toffa S, Rickeard T, Gallagher E, Gower C, Kall M, Groves N, O'Connell AM, Simons D, Blomquist PB, Zaidi A, Nash S, Iwani Binti Abdul Aziz N, Thelwall S, Dabrera G, Myers R, Amirthalingam G, Gharbia S, Barrett JC, Elson R, Ladhani SN, Ferguson N, Zambon M, Campbell CNJ, Brown K, Hopkins S, Chand M, Ramsay M, Lopez Bernal J (2022) Covid-19 vaccine effectiveness against the Omicron (B.1.1.529) Variant. N Engl J Med 386(16):1532–1546. https://doi.org/10.1056/NEJMoa2119451
Hendin HE, Pillet S, Lara AN, Wu CY, Charland N, Landry N, Ward BJ (2017) Plant-made virus-like particle vaccines bearing the hemagglutinin of either seasonal (H1) or avian (H5) influenza have distinct patterns of interaction with human immune cells in vitro. Vaccine 35(19):2592–2599. https://doi.org/10.1016/j.vaccine.2017.03.058
Article CAS PubMed Google Scholar
Makarkov AI, Chierzi S, Pillet S, Murai KK, Landry N, Ward BJ (2017) Plant-made virus-like particles bearing influenza hemagglutinin (HA) recapitulate early interactions of native influenza virions with human monocytes/macrophages. Vaccine 35(35 Pt B):4629–4636. https://doi.org/10.1016/j.vaccine.2017.07.012
Makarkov AI, Golizeh M, Ruiz-Lancheros E, Gopal AA, Costas-Cancelas IN, Chierzi S, Pillet S, Charland N, Landry N, Rouiller I, Wiseman PW, Ndao M, Ward BJ (2019) Plant-derived virus-like particle vaccines drive cross-presentation of influenza A hemagglutinin peptides by human monocyte-derived macrophages. NPJ Vaccines 4:17. https://doi.org/10.1038/s41541-019-0111-y
Article CAS PubMed PubMed Central Google Scholar
Liu J, Dai S, Wang M, Hu Z, Wang H, Deng F (2016) Virus like particle-based vaccines against emerging infectious disease viruses. Virol Sin 31(4):279–287. https://doi.org/10.1007/s12250-016-3756-y
Article CAS PubMed PubMed Central Google Scholar
Moffat JM, Cheong WS, Villadangos JA, Mintern JD, Netter HJ (2013) Hepatitis B virus-like particles access major histocompatibility class I and II antigen presentation pathways in primary dendritic cells. Vaccine 31(18):2310–2316. https://doi.org/10.1016/j.vaccine.2013.02.042
Article CAS PubMed Google Scholar
Lindsay BJ, Bonar MM, Costas-Cancelas IN, Hunt K, Makarkov AI, Chierzi S, Krawczyk CM, Landry N, Ward BJ, Rouiller I (2018) Morphological characterization of a plant-made virus-like particle vaccine bearing influenza virus hemagglutinins by electron microscopy. Vaccine 36(16):2147–2154. https://doi.org/10.1016/j.vaccine.2018.02.106
Article CAS PubMed Google Scholar
Won SY, Hunt K, Guak H, Hasaj B, Charland N, Landry N, Ward BJ, Krawczyk CM (2018) Characterization of the innate stimulatory capacity of plant-derived virus-like particles bearing influenza hemagglutinin. Vaccine 36(52):8028–8038. https://doi.org/10.1016/j.vaccine.2018.10.099
Article CAS PubMed Google Scholar
Mohsen MO, Zha L, Cabral-Miranda G, Bachmann MF (2017) Major findings and recent advances in virus-like particle (VLP)-based vaccines. Semin Immunol 34:123–132. https://doi.org/10.1016/j.smim.2017.08.014
Article CAS PubMed Google Scholar
Mor TS (2015) Molecular pharming’s foot in the FDA’s door: Protalix’s trailblazing story. Biotechnol Lett 37(11):2147–2150. https://doi.org/10.1007/s10529-015-1908-z
Article CAS PubMed PubMed Central Google Scholar
Ward BJ, Makarkov A, Seguin A, Pillet S, Trepanier S, Dhaliwall J, Libman MD, Vesikari T, Landry N (2020) Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18–64 years) and older adults (>/=65 years): two multicentre, randomised phase 3 trials. Lancet 396(10261):1491–1503. https://doi.org/10.1016/S0140-6736(20)32014-6
Article CAS PubMed Google Scholar
Hager KJ, Pérez Marc G, Gobeil P, Diaz RS, Heizer G, Llapur C, Makarkov AI, Vasconcellos E, Pillet S, Riera F, Saxena P, Geller Wolff P, Bhutada K, Wallace G, Aazami H, Jones CE, Polack FP, Ferrara L, Atkins J, Boulay I, Dhaliwall J, Charland N, Couture MMJ, Jiang-Wright J, Landry N, Lapointe S, Lorin A, Mahmood A, Moulton LH, Pahmer E, Parent J, Séguin A, Tran L, Breuer T, Ceregido MA, Koutsoukos M, Roman F, Namba J, D’Aoust MA, Trepanier S, Kimura Y, Ward BJ (2022) Efficacy and safety of a recombinant plant-based adjuvanted Covid-19 vaccine. N Engl J Med 386(22):2084–2096. https://doi.org/10.1056/NEJMoa2201300
Article CAS PubMed Google Scholar
Chen DS (2009) Hepatitis B vaccination: the key towards elimination and eradication of hepatitis B. J Hepatol 50(4):805–816. https://doi.org/10.1016/j.jhep.2009.01.002
Wheeler CM, Skinner SR, Del Rosario-Raymundo MR, Garland SM, Chatterjee A, Lazcano-Ponce E, Salmeron J, McNeil S, Stapleton JT, Bouchard C, Martens MG, Money DM, Quek SC, Romanowski B, Vallejos CS, Ter Harmsel B, Prilepskaya V, Fong KL, Kitchener H, Minkina G, Lim YKT, Stoney T, Chakhtoura N, Cruickshank ME, Savicheva A, da Silva DP, Ferguson M, Molijn AC, Quint WGV, Hardt K, Descamps D, Suryakiran PV, Karkada N, Geeraerts B, Dubin G, Struyf F, Group VS (2016) Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study. Lancet Infect Dis 16(10):1154–1168. https://doi.org/10.1016/S1473-3099(16)30120-7
Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barbera J, Vanden Abeele C, Vesikari T, Watanabe D, Zahaf T, Ahonen A, Athan E, Barba-Gomez JF, Campora L, de Looze F, Downey HJ, Ghesquiere W, Gorfinkel I, Korhonen T, Leung E, McNeil SA, Oostvogels L, Rombo L, Smetana J, Weckx L, Yeo W, Heineman TC, Group ZOES (2016) Efficacy of the Herpes Zoster subunit vaccine in adults 70 years of age or older. N Engl J Med 375(11):1019–1032. https://doi.org/10.1056/NEJMoa1603800
Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, Plested JS, Zhu M, Cloney-Clark S, Zhou H, Smith G, Patel N, Frieman MB, Haupt RE, Logue J, McGrath M, Weston S, Piedra PA, Desai C, Callahan K, Lewis M, Price-Abbott P, Formica N, Shinde V, Fries L, Lickliter JD, Griffin P, Wilkinson B, Glenn GM (2020) Phase 1–2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. N Engl J Med 383(24):2320–2332. https://doi.org/10.1056/NEJMoa2026920
Article CAS PubMed Google Scholar
Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, Chadwick DR, Clark R, Cosgrove C, Galloway J, Goodman AL, Heer A, Higham A, Iyengar S, Jamal A, Jeanes C, Kalra PA, Kyriakidou C, McAuley DF, Meyrick A, Minassian AM, Minton J, Moore P, Munsoor I, Nicholls H, Osanlou O, Packham J, Pretswell CH, Francisco Ramos AS, Saralaya D, Sheridan RP, Smith R, Soiza RL, Swift PA, Thomson EC, Turner J, Viljoen ME, Albert G, Cho I, Dubovsky F, Glenn G, Rivers J, Robertson A, Smith K, Toback S (2021) Efficacy of the NVX-CoV2373 Covid-19 vaccine against the B.1.1.7 variant. medRxiv: 2021.2005.2013.21256639. https://doi.org/10.1101/2021.05.13.21256639
Goepfert PA, Fu B, Chabanon AL, Bonaparte MI, Davis MG, Essink BJ, Frank I, Haney O, Janosczyk H, Keefer MC, Koutsoukos M, Kimmel MA, Masotti R, Savarino SJ, Schuerman L, Schwartz H, Sher LD, Smith J, Tavares-Da-Silva F, Gurunathan S, DiazGranados CA, de Bruyn G (2021) Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1–2, dose-ranging study. Lancet Infect Dis. https://doi.org/10.1016/S1473-3099(21)00147-X
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