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Page 1
A Randomised Clinical Trial of the Safety and Pharmacokinetics of VRC07-523LS Administered via Different Routes and Doses (HVTN 127/HPTN 087).
Walsh SR, Gay CL, Karuna ST, Hyrien O, Skalland T, Mayer KH, Sobieszczyk ME, Baden LR, Goepfert PA, Del Rio C, Pantaleo G, Andrew P, Karg C, He Z, Lu H, Paez CA, Baumblatt JAG, Polakowski LL, Chege W, Janto S, Han X, Huang Y, Dumond J, Ackerman ME, McDermott AB, Flach B, Piwowar-Manning E, Seaton K, Tomaras GD, Montefiori DC, Gama L, Mascola JR; HVTN 127/HPTN 087 Study Team. Walsh SR, et al. Among authors: flach b. medRxiv [Preprint]. 2024 Jan 11:2024.01.10.23299799. doi: 10.1101/2024.01.10.23299799. medRxiv. 2024. PMID: 38260276 Free PMC article. Preprint.
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: flach b. Viruses. 2023 Sep 29;15(10):2029. doi: 10.3390/v15102029. Viruses. 2023. PMID: 37896806 Free PMC article. Clinical Trial.
Safety, tolerability, and immunogenicity of the Ebola Sudan chimpanzee adenovirus vector vaccine (cAd3-EBO S) in healthy Ugandan adults: a phase 1, open-label, dose-escalation clinical trial.
Mwesigwa B, Houser KV, Hofstetter AR, Ortega-Villa AM, Naluyima P, Kiweewa F, Nakabuye I, Yamshchikov GV, Andrews C, O'Callahan M, Strom L, Schech S, Anne Eller L, Sondergaard EL, Scott PT, Amare MF, Modjarrad K, Wamala A, Tindikahwa A, Musingye E, Nanyondo J, Gaudinski MR, Gordon IJ, Holman LA, Saunders JG, Costner PJM, Mendoza FH, Happe M, Morgan P, Plummer SH, Hickman SP, Vazquez S, Murray T, Cordon J, Dulan CNM, Hunegnaw R, Basappa M, Padilla M, Gajjala SR, Swanson PA 2nd, Lin BC, Coates EE, Gall JG, McDermott AB, Koup RA, Mascola JR, Ploquin A, Sullivan NJ, Kibuuka H, Ake JA, Ledgerwood JE; RV 508 Study Team. Mwesigwa B, et al. Lancet Infect Dis. 2023 Dec;23(12):1408-1417. doi: 10.1016/S1473-3099(23)00344-4. Epub 2023 Aug 3. Lancet Infect Dis. 2023. PMID: 37544326 Clinical Trial.
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: flach b. 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.
Safety, tolerability, and immunogenicity of the chimpanzee adenovirus type 3-vectored Marburg virus (cAd3-Marburg) vaccine in healthy adults in the USA: a first-in-human, phase 1, open-label, dose-escalation trial.
Hamer MJ, Houser KV, Hofstetter AR, Ortega-Villa AM, Lee C, Preston A, Augustine B, Andrews C, Yamshchikov GV, Hickman S, Schech S, Hutter JN, Scott PT, Waterman PE, Amare MF, Kioko V, Storme C, Modjarrad K, McCauley MD, Robb ML, Gaudinski MR, Gordon IJ, Holman LA, Widge AT, Strom L, Happe M, Cox JH, Vazquez S, Stanley DA, Murray T, Dulan CNM, Hunegnaw R, Narpala SR, Swanson PA 2nd, Basappa M, Thillainathan J, Padilla M, Flach B, O'Connell S, Trofymenko O, Morgan P, Coates EE, Gall JG, McDermott AB, Koup RA, Mascola JR, Ploquin A, Sullivan NJ, Ake JA, Ledgerwood JE; RV 507 Study Team. Hamer MJ, et al. Among authors: flach b. Lancet. 2023 Jan 28;401(10373):294-302. doi: 10.1016/S0140-6736(22)02400-X. Lancet. 2023. PMID: 36709074 Free PMC article. Clinical Trial.
Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial.
Fong Y, McDermott AB, Benkeser D, Roels S, Stieh DJ, Vandebosch A, Le Gars M, Van Roey GA, Houchens CR, Martins K, Jayashankar L, Castellino F, Amoa-Awua O, Basappa M, Flach B, Lin BC, Moore C, Naisan M, Naqvi M, Narpala S, O'Connell S, Mueller A, Serebryannyy L, Castro M, Wang J, Petropoulos CJ, Luedtke A, Hyrien O, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Kenny A, Carone M, Wolfe DN, Sadoff J, Gray GE, Grinsztejn B, Goepfert PA, Little SJ, Paiva de Sousa L, Maboa R, Randhawa AK, Andrasik MP, Hendriks J, Truyers C, Struyf F, Schuitemaker H, Douoguih M, Kublin JG, Corey L, Neuzil KM, Carpp LN, Follmann D, Gilbert PB, Koup RA, Donis RO; Immune Assays Team; the Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team; and the United States Government (USG)/CoVPN Biostatistics Team. Fong Y, et al. Among authors: flach b. Nat Microbiol. 2022 Dec;7(12):1996-2010. doi: 10.1038/s41564-022-01262-1. Epub 2022 Nov 10. Nat Microbiol. 2022. PMID: 36357712 Free PMC article. Clinical Trial.
Achieving intracellular cytokine staining assay concordance on two continents to assess HIV vaccine-induced T-cell responses.
Dintwe OB, De Rosa SC, Huang Y, Flach BS, Manso B, Carter D, Omar FL, Schwedhelm KV, Yu C, Lu H, Morris D, Kee JJ, Voillet V, Stirewalt M, Hural J, Moodie Z, Frahm N, Cohen KW, McElrath MJ, Andersen-Nissen E. Dintwe OB, et al. Among authors: flach bs. J Leukoc Biol. 2022 Nov;112(5):1167-1181. doi: 10.1002/JLB.5MA0522-668R. Epub 2022 Jul 22. J Leukoc Biol. 2022. PMID: 35866359 Free PMC article.
Safety and immunogenicity of an HIV-1 prefusion-stabilized envelope trimer (Trimer 4571) vaccine in healthy adults: A first-in-human open-label, randomized, dose-escalation, phase 1 clinical trial.
Houser KV, Gaudinski MR, Happe M, Narpala S, Verardi R, Sarfo EK, Corrigan AR, Wu R, Rothwell RS, Novik L, Hendel CS, Gordon IJ, Berkowitz NM, Cartagena CT, Widge AT, Coates EE, Strom L, Hickman S, Conan-Cibotti M, Vazquez S, Trofymenko O, Plummer S, Stein J, Case CL, Nason M, Biju A, Parchment DK, Changela A, Cheng C, Duan H, Geng H, Teng IT, Zhou T, O'Connell S, Barry C, Carlton K, Gall JG, Flach B, Doria-Rose NA, Graham BS, Koup RA, McDermott AB, Mascola JR, Kwong PD, Ledgerwood JE; VRC 018 Study Team. Houser KV, et al. Among authors: flach b. EClinicalMedicine. 2022 Jun 1;48:101477. doi: 10.1016/j.eclinm.2022.101477. eCollection 2022 Jun. EClinicalMedicine. 2022. PMID: 35783486 Free PMC article.
Immune Correlates Analysis of a Single Ad26.COV2.S Dose in the ENSEMBLE COVID-19 Vaccine Efficacy Clinical Trial.
Fong Y, McDermott AB, Benkeser D, Roels S, Stieh DJ, Vandebosch A, Gars ML, Van Roey GA, Houchens CR, Martins K, Jayashankar L, Castellino F, Amoa-Awua O, Basappa M, Flach B, Lin BC, Moore C, Naisan M, Naqvi M, Narpala S, O'Connell S, Mueller A, Serebryannyy L, Castro M, Wang J, Petropoulos CJ, Luedtke A, Hyrien O, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Kenny A, Carone M, Wolfe DN, Sadoff J, Gray GE, Grinsztejn B, Goepfert PA, Little SJ, de Sousa LP, Maboa R, Randhawa AK, Andrasik MP, Hendriks J, Truyers C, Struyf F, Schuitemaker H, Douoguih M, Kublin JG, Corey L, Neuzil KM, Carpp LN, Follmann D, Gilbert PB, Koup RA, Donis RO; Janssen Team; Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team; United States Government (USG)/CoVPN Biostatistics Team. Fong Y, et al. Among authors: flach b. medRxiv [Preprint]. 2022 Apr 12:2022.04.06.22272763. doi: 10.1101/2022.04.06.22272763. medRxiv. 2022. PMID: 35441174 Free PMC article. Updated. Preprint.
Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial.
Casazza JP, Cale EM, Narpala S, Yamshchikov GV, Coates EE, Hendel CS, Novik L, Holman LA, Widge AT, Apte P, Gordon I, Gaudinski MR, Conan-Cibotti M, Lin BC, Nason MC, Trofymenko O, Telscher S, Plummer SH, Wycuff D, Adams WC, Pandey JP, McDermott A, Roederer M, Sukienik AN, O'Dell S, Gall JG, Flach B, Terry TL, Choe M, Shi W, Chen X, Kaltovich F, Saunders KO, Stein JA, Doria-Rose NA, Schwartz RM, Balazs AB, Baltimore D, Nabel GJ, Koup RA, Graham BS, Ledgerwood JE, Mascola JR; VRC 603 Study Team. Casazza JP, et al. Among authors: flach b. Nat Med. 2022 May;28(5):1022-1030. doi: 10.1038/s41591-022-01762-x. Epub 2022 Apr 11. Nat Med. 2022. PMID: 35411076 Free PMC article. Clinical Trial.
47 results