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Page 1
Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks.
Dean NE, Gsell PS, Brookmeyer R, Crawford FW, Donnelly CA, Ellenberg SS, Fleming TR, Halloran ME, Horby P, Jaki T, Krause PR, Longini IM, Mulangu S, Muyembe-Tamfum JJ, Nason MC, Smith PG, Wang R, Henao-Restrepo AM, De Gruttola V. Dean NE, et al. Among authors: nason mc. N Engl J Med. 2020 Apr 2;382(14):1366-1369. doi: 10.1056/NEJMsb1905390. N Engl J Med. 2020. PMID: 32242365 Free PMC article. No abstract available.
Use of placebos in Phase 1 preventive HIV vaccine clinical trials.
Huang Y, Karuna ST, Janes H, Frahm N, Nason M, Edlefsen PT, Kublin JG, Corey L, McElrath MJ, Gilbert PB. Huang Y, et al. Vaccine. 2015 Feb 4;33(6):749-52. doi: 10.1016/j.vaccine.2014.10.017. Epub 2014 Oct 23. Vaccine. 2015. PMID: 25454855 Free PMC article.
Design of vaccine efficacy trials during public health emergencies.
Dean NE, Gsell PS, Brookmeyer R, De Gruttola V, Donnelly CA, Halloran ME, Jasseh M, Nason M, Riveros X, Watson CH, Henao-Restrepo AM, Longini IM. Dean NE, et al. Sci Transl Med. 2019 Jul 3;11(499):eaat0360. doi: 10.1126/scitranslmed.aat0360. Sci Transl Med. 2019. PMID: 31270270 Free PMC article. Review.
COVID-19 vaccine trials should seek worthwhile efficacy.
Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R; World Health Organization Solidarity Vaccines Trial Expert Group. Krause P, et al. Lancet. 2020 Sep 12;396(10253):741-743. doi: 10.1016/S0140-6736(20)31821-3. Epub 2020 Aug 27. Lancet. 2020. PMID: 32861315 Free PMC article. No abstract available.
Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials.
Mehrotra DV, Janes HE, Fleming TR, Annunziato PW, Neuzil KM, Carpp LN, Benkeser D, Brown ER, Carone M, Cho I, Donnell D, Fay MP, Fong Y, Han S, Hirsch I, Huang Y, Huang Y, Hyrien O, Juraska M, Luedtke A, Nason M, Vandebosch A, Zhou H, Cohen MS, Corey L, Hartzel J, Follmann D, Gilbert PB. Mehrotra DV, et al. Ann Intern Med. 2021 Feb;174(2):221-228. doi: 10.7326/M20-6169. Epub 2020 Oct 22. Ann Intern Med. 2021. PMID: 33090877 Free PMC article.
Placebo-Controlled Trials of Covid-19 Vaccines - Why We Still Need Them.
WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation; Krause PR, Fleming TR, Longini IM, Peto R, Beral V, Bhargava B, Cravioto A, Cramer JP, Ellenberg SS, Figueroa JP, Halloran E, Henao-Restrepo AM, Ryan MJ, Levine MM, Nason M, Nohynek HM, Plotkin S, Rees H, Singh JA, Swaminathan S. WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation, et al. N Engl J Med. 2021 Jan 14;384(2):e2. doi: 10.1056/NEJMp2033538. Epub 2020 Dec 2. N Engl J Med. 2021. PMID: 33264543 No abstract available.
A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated.
Follmann D, Fintzi J, Fay MP, Janes HE, Baden LR, El Sahly HM, Fleming TR, Mehrotra DV, Carpp LN, Juraska M, Benkeser D, Donnell D, Fong Y, Han S, Hirsch I, Huang Y, Huang Y, Hyrien O, Luedtke A, Carone M, Nason M, Vandebosch A, Zhou H, Cho I, Gabriel E, Kublin JG, Cohen MS, Corey L, Gilbert PB, Neuzil KM. Follmann D, et al. Ann Intern Med. 2021 Aug;174(8):1118-1125. doi: 10.7326/M20-8149. Epub 2021 Apr 13. Ann Intern Med. 2021. PMID: 33844575 Free PMC article.
COVID-19 vaccine trials: The potential for "hybrid" analyses.
Fleming TR, Nason M, Krause PR, Longini IM, Henao-Restrepo AM. Fleming TR, et al. Clin Trials. 2021 Aug;18(4):391-397. doi: 10.1177/17407745211018613. Epub 2021 May 27. Clin Trials. 2021. PMID: 34041932 Free PMC article.
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico.
Dunkle LM, Kotloff KL, Gay CL, Áñez G, Adelglass JM, Barrat Hernández AQ, Harper WL, Duncanson DM, McArthur MA, Florescu DF, McClelland RS, Garcia-Fragoso V, Riesenberg RA, Musante DB, Fried DL, Safirstein BE, McKenzie M, Jeanfreau RJ, Kingsley JK, Henderson JA, Lane DC, Ruíz-Palacios GM, Corey L, Neuzil KM, Coombs RW, Greninger AL, Hutter J, Ake JA, Smith K, Woo W, Cho I, Glenn GM, Dubovsky F; 2019nCoV-301 Study Group. Dunkle LM, et al. N Engl J Med. 2022 Feb 10;386(6):531-543. doi: 10.1056/NEJMoa2116185. Epub 2021 Dec 15. N Engl J Med. 2022. PMID: 34910859 Free PMC article. Clinical Trial.
138 results