{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T04:10:36Z","timestamp":1793074236813,"version":"4.5.0"},"reference-count":39,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T00:00:00Z","timestamp":1721174400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T00:00:00Z","timestamp":1721174400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100012681","name":"Universit\u00e4tsklinikum K\u00f6ln","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100012681","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Infection"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>WHO postulates the application of adaptive design features in the global clinical trial ecosystem. However, the adaptive platform trial (APT) methodology has not been widely adopted in clinical research on vaccines.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The VACCELERATE Consortium organized a two-day workshop to discuss the applicability of APT methodology in vaccine trials under non-pandemic as well as pandemic conditions. Core aspects of the discussions are summarized in this article.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>An \u201cever-warm\u201d APT appears ideally suited to improve efficiency and speed of vaccine research. Continuous learning based on accumulating APT trial data allows for pre-planned adaptations during its course. Given the relative design complexity, alignment of all stakeholders at all stages of an APT is central. Vaccine trial modelling is crucial, both before and in a pandemic emergency. Various inferential paradigms are possible (frequentist, likelihood, or Bayesian). The focus in the interpandemic interval may be on research gaps left by industry trials. For activation in emergency, template Disease X protocols of syndromal design for pathogens yet unknown need to be stockpiled and updated regularly. Governance of a vaccine APT should be fully integrated into supranational pandemic response mechanisms.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>A broad range of adaptive features can be applied in platform trials on vaccines. Faster knowledge generation comes with increased complexity of trial design. Design complexity should not preclude simple execution at trial sites. Continuously generated evidence represents a return on investment that will garner societal support for sustainable funding. Adaptive design features will naturally find their way into platform trials on vaccines.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s15010-024-02347-1","type":"journal-article","created":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T12:01:57Z","timestamp":1721217717000},"page":"2135-2144","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Innovative approaches for vaccine trials as a key component of pandemic preparedness \u2013 a white paper"],"prefix":"10.1007","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9979-1671","authenticated-orcid":false,"given":"Ullrich","family":"Bethe","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5893-1081","authenticated-orcid":false,"given":"Zoi D.","family":"Pana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7923-0519","authenticated-orcid":false,"given":"Christian","family":"Drosten","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4891-4031","authenticated-orcid":false,"given":"Herman","family":"Goossens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6893-3304","authenticated-orcid":false,"given":"Franz","family":"K\u00f6nig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0007-382X","authenticated-orcid":false,"given":"Arnaud","family":"Marchant","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6453-5448","authenticated-orcid":false,"given":"Geert","family":"Molenberghs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8499-8573","authenticated-orcid":false,"given":"Martin","family":"Posch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8642-1249","authenticated-orcid":false,"given":"Pierre","family":"Van Damme","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9599-3137","authenticated-orcid":false,"given":"Oliver A.","family":"Cornely","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,7,17]]},"reference":[{"key":"2347_CR1","doi-asserted-by":"publisher","first-page":"124","DOI":"10.1016\/S0140-6736(23)02798-8","volume":"403","author":"V Moorthy","year":"2024","unstructured":"Moorthy V, Abubakar I, Qadri F, Ogutu B, Zhang W, Reeder J, Farrar J. 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Pana, Christian Drosten, Franz K\u00f6nig, Herman Goossens, Arnaud Marchant, Geert Molenberghs, Martin Posch: no conflicts declared. Pierre Van Damme (PVD): Grant from CEPI-HERA for COVID-19 vaccine assessment, payments made to PVD\u2019s institution. Participation on a Data Safety Monitoring Board or Advisory Board of Janssen Vaccines, no payments received, and of LG Chem, payments made to PVD\u2019s institution. Oliver A. Cornely (OAC): Grants or contracts from BMBF, Cidara, DZIF, EU-DG RTD, F2G, Gilead, MedPace, MSD, Mundipharma, Octapharma, Pfizer, Scynexis, payments made to OAC\u2019s institution. Consulting fees from Abbvie, AiCuris, Basilea, Biocon, Cidara, Seqirus, Gilead, GSK, IQVIA, Janssen, Matinas, MedPace, Menarini, Molecular Partners, MSG-ERC, Mundipharma, Noxxon, Octapharma, Pardes, Partner Therapeutics, Pfizer, PSI, Scynexis, Seres, payments made to OAC. Payments or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbott, Abbvie, Akademie f\u00fcr Infektionsmedizin, Al-Jazeera Pharmaceuticals\/Hikma, amedes, AstraZeneca, Biotoscana Farma, Deutscher \u00c4rzteverlag, Gilead, GSK, Grupo Biotoscana\/United Medical\/Knight, Medscape\/WebMD, MedUpdate, MSD, Moderna, Mundipharma, Noscendo, Paul-Martini-Stiftung, Pfizer, Sandoz, Seqirus, Shionogi, streamedup!, Touch Independent, Vitis, payments made to OAC. Payment for expert testimony Cidara, payments made to OAC. Patents planned, issued or pending: Patent US18\/562644, \u201cGeschlossene Inkubationssysteme mit verbessertem Atemwegszugang f\u00fcr Untersuchungsvorrichtungen\u201d, DE 10 2021 113 007.7), filed by the University of Cologne and listing OAC as one of three inventors. Participation on a Data Safety Monitoring Board or Advisory Board of Boston Strategic Partners, Cidara, IQVIA, Janssen, MedPace, PSI, Pulmocide, Shionogi, The Prime Meridian Group, payments made to OAC.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}