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Page 1
Stochastic Interventional Vaccine Efficacy and Principal Surrogate Analyses of Antibody Markers as Correlates of Protection against Symptomatic COVID-19 in the COVE mRNA-1273 Trial.
Huang Y, Hejazi NS, Blette B, Carpp LN, Benkeser D, Montefiori DC, McDermott AB, Fong Y, Janes HE, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Kenny A, Carone M, Huynh C, Miller J, El Sahly HM, Baden LR, Jackson LA, Campbell TB, Clark J, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Pajon R, Follmann D, Donis RO, Koup RA, Gilbert PB, On Behalf Of The Immune Assays, Moderna Inc, Coronavirus Vaccine Prevention Network CoVPN/Coronavirus Efficacy Cove, United States Government Usg/CoVPN Biostatistics Teams. Huang Y, et al. Among authors: zhou h. Viruses. 2023 Sep 29;15(10):2029. doi: 10.3390/v15102029. Viruses. 2023. PMID: 37896806 Free PMC article. Clinical Trial.
Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.
Gilbert PB, Montefiori DC, McDermott AB, Fong Y, Benkeser D, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Castellino F, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Huynh C, Miller J, El Sahly HM, Baden LR, Baron M, De La Cruz L, Gay C, Kalams S, Kelley CF, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Carpp LN, Pajon R, Follmann D, Donis RO, Koup RA; Immune Assays Team§; Moderna, Inc. Team§; Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team§; United States Government (USG)/CoVPN Biostatistics Team§. Gilbert PB, et al. Among authors: zhou h. Science. 2022 Jan 7;375(6576):43-50. doi: 10.1126/science.abm3425. Epub 2021 Nov 23. Science. 2022. PMID: 34812653 Free PMC article.
Comparing antibody assays as correlates of protection against COVID-19 in the COVE mRNA-1273 vaccine efficacy trial.
Benkeser D, Montefiori DC, McDermott AB, Fong Y, Janes HE, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Castellino F, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Kenny A, Carone M, Williamson BD, Garver J, Altonen E, Rudge T, Huynh C, Miller J, El Sahly HM, Baden LR, Frey S, Malkin E, Spector SA, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Carpp LN, Pajon R, Follmann D, Donis RO, Koup RA, Gilbert PB; Immune Assays; Moderna Inc.; Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE); United States Government (USG)/CoVPN Biostatistics Teams. Benkeser D, et al. Among authors: zhou h. Sci Transl Med. 2023 Apr 19;15(692):eade9078. doi: 10.1126/scitranslmed.ade9078. Epub 2023 Apr 19. Sci Transl Med. 2023. PMID: 37075127 Free PMC article. Clinical Trial.
Stochastic interventional approach to assessing immune correlates of protection: Application to the COVE messenger RNA-1273 vaccine trial.
Hejazi NS, Shen X, Carpp LN, Benkeser D, Follmann D, Janes HE, Baden LR, El Sahly HM, Deng W, Zhou H, Leav B, Montefiori DC, Gilbert PB. Hejazi NS, et al. Among authors: zhou h. Int J Infect Dis. 2023 Dec;137:28-39. doi: 10.1016/j.ijid.2023.09.012. Epub 2023 Oct 25. Int J Infect Dis. 2023. PMID: 37820782 Free PMC article. Clinical Trial.
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. Among authors: zhou h. 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.
Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Baden LR, et al. Among authors: zhou h. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30. N Engl J Med. 2021. PMID: 33378609 Free PMC article. Clinical Trial.
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. Among authors: zhou h. 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.
Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase.
El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, Campbell TB, Clark J, Jackson LA, Fichtenbaum CJ, Zervos M, Rankin B, Eder F, Feldman G, Kennelly C, Han-Conrad L, Levin M, Neuzil KM, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Polakowski L, Mascola JR, Ledgerwood JE, Graham BS, August A, Clouting H, Deng W, Han S, Leav B, Manzo D, Pajon R, Schödel F, Tomassini JE, Zhou H, Miller J; COVE Study Group. El Sahly HM, et al. Among authors: zhou h. N Engl J Med. 2021 Nov 4;385(19):1774-1785. doi: 10.1056/NEJMoa2113017. Epub 2021 Sep 22. N Engl J Med. 2021. PMID: 34551225 Free PMC article. Clinical Trial.
Humoral Immunogenicity of the mRNA-1273 Vaccine in the Phase 3 Coronavirus Efficacy (COVE) Trial.
El Sahly HM, Baden LR, Essink B, Montefiori D, McDermont A, Rupp R, Lewis M, Swaminathan S, Griffin C, Fragoso V, Miller VE, Girard B, Paila YD, Deng W, Tomassini JE, Paris R, Schödel F, Das R, August A, Leav B, Miller JM, Zhou H, Pajon R; Coronavirus Efficacy (COVE) Study Group. El Sahly HM, et al. Among authors: zhou h. J Infect Dis. 2022 Nov 11;226(10):1731-1742. doi: 10.1093/infdis/jiac188. J Infect Dis. 2022. PMID: 35535503 Free PMC article. Clinical Trial.
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