{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T18:11:53Z","timestamp":1788631913227,"version":"build-2803163510"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T00:00:00Z","timestamp":1721952000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T00:00:00Z","timestamp":1721952000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100023410","name":"Snow Medical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100023410","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["2014690"],"award-info":[{"award-number":["2014690"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["2016473"],"award-info":[{"award-number":["2016473"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The Platform trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site, adaptive platform trial designed to generate evidence of the immunogenicity, reactogenicity, and cross-protection of different booster vaccination strategies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants, specific for the Australian context. The PICOBOO trial randomises participants to receive one of three COVID-19 booster vaccine brands (Pfizer, Moderna, Novavax) available for use in Australia, where the vaccine brand subtypes vary over time according to the national vaccine roll out strategy, and employs a Bayesian hierarchical modelling approach to efficiently borrow information across consecutive booster doses, age groups and vaccine brand subtypes. Here, we briefly describe the PICOBOO trial structure and report the statistical considerations for the estimands, statistical models and decision making for trial adaptations. This paper should be read in conjunction with the PICOBOO Core Protocol and PICOBOO Sub-Study Protocol 1: Booster Vaccination. PICOBOO was registered on 10 February 2022 with the Australian and New Zealand Clinical Trials Registry ACTRN12622000238774.<\/jats:p>","DOI":"10.1186\/s13063-024-08343-y","type":"journal-article","created":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T20:03:05Z","timestamp":1722024185000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Statistical considerations for the platform trial in COVID-19 vaccine priming and boosting"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4881-2860","authenticated-orcid":false,"given":"Michael","family":"Dymock","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlie","family":"McLeod","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Richmond","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Snelling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie A.","family":"Marsh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"On behalf of the PICOBOO Investigator Team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,7,26]]},"reference":[{"issue":"10308","key":"8343_CR1","doi-asserted-by":"publisher","first-page":"1377","DOI":"10.1016\/S0140-6736(21)02046-8","volume":"398","author":"PR Krause","year":"2021","unstructured":"Krause PR, Fleming TR, Peto R, Longini IM, Figueroa JP, Sterne JAC, et al. Considerations in boosting COVID-19 vaccine immune responses. Lancet. 2021;398(10308):1377\u201380.","journal-title":"Lancet."},{"issue":"4","key":"8343_CR2","doi-asserted-by":"publisher","first-page":"1336","DOI":"10.1002\/jmv.27487","volume":"94","author":"K Mohamed","year":"2022","unstructured":"Mohamed K, Rzymski P, Islam MS, Makuku R, Mushtaq A, Khan A, et al. COVID-19 vaccinations: the unknowns, challenges, and hopes. J Med Virol. 2022;94(4):1336\u201349.","journal-title":"J Med Virol."},{"issue":"18","key":"8343_CR3","doi-asserted-by":"publisher","first-page":"1701","DOI":"10.1056\/NEJMp2027405","volume":"383","author":"M Slaoui","year":"2020","unstructured":"Slaoui M, Hepburn M. Developing safe and effective COVID vaccines \u2014 operation warp speed\u2019s strategy and approach. N Engl J Med. 2020;383(18):1701\u20133.","journal-title":"N Engl J Med."},{"key":"8343_CR4","doi-asserted-by":"publisher","unstructured":"Berry SM, Connor JT, Lewis RJ. The Platform Trial: an efficient strategy for evaluating multiple treatments. JAMA. 2015 04;313(16):1619\u20131620. https:\/\/doi.org\/10.1001\/jama.2015.2316.","DOI":"10.1001\/jama.2015.2316"},{"issue":"3","key":"8343_CR5","doi-asserted-by":"publisher","first-page":"358","DOI":"10.1177\/1740774515626362","volume":"13","author":"BR Saville","year":"2016","unstructured":"Saville BR, Berry SM. Efficiencies of platform clinical trials: a vision of the future. Clin Trials. 2016;13(3):358\u201366. https:\/\/doi.org\/10.1177\/1740774515626362.","journal-title":"Clin Trials."},{"issue":"7","key":"8343_CR6","doi-asserted-by":"publisher","first-page":"1330","DOI":"10.1016\/j.clinthera.2020.05.010","volume":"42","author":"EL Meyer","year":"2020","unstructured":"Meyer EL, Mesenbrink P, Dunger-Baldauf C, Li Y, Posch M, K\u00f6nig F. The evolution of master protocol clinical trial designs: a systematic literature review. Clin Ther. 2020;42(7):1330\u201360. https:\/\/doi.org\/10.1016\/j.clinthera.2020.05.010.","journal-title":"Clin Ther."},{"key":"8343_CR7","doi-asserted-by":"publisher","unstructured":"McLeod C, Ramsay J, Flanagan KL, Plebanski M, Marshall H, Dymock M, et\u00a0al. Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO). Trials. 2023;24(202). https:\/\/doi.org\/10.1186\/s13063-023-07225-z.","DOI":"10.1186\/s13063-023-07225-z"},{"key":"8343_CR8","doi-asserted-by":"publisher","unstructured":"Gelman A, Carlin JB, Stern HS, Dunson DB, Vehtari A, Rubin DB. Bayesian data analysis. 3rd ed. United States: Chapman and Hall\/CRC; 2013. https:\/\/doi.org\/10.1201\/b16018.","DOI":"10.1201\/b16018"},{"issue":"22","key":"8343_CR9","doi-asserted-by":"publisher","first-page":"2365","DOI":"10.1001\/jama.2018.17977","volume":"320","author":"AE McGlothlin","year":"2018","unstructured":"McGlothlin AE, Viele K. Bayesian hierarchical models. 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Informed consent to participate will be obtained from all participants in either written or electronic form.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request and will be available on the trial website.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"507"}}