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Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial.
Lyke KE, Berry AA, Mason K, Idris AH, O'Callahan M, Happe M, Strom L, Berkowitz NM, Guech M, Hu Z, Castro M, Basappa M, Wang L, Low K, Holman LA, Mendoza F, Gordon IJ, Plummer SH, Trofymenko O, Strauss KS, Joshi S, Shrestha B, Adams M, Chagas AC, Murphy JR, Stein J, Hickman S, McDougal A, Lin B, Narpala SR, Vazquez S, Serebryannyy L, McDermott A, Gaudinski MR, Capparelli EV, Coates EE, Wu RL, Ledgerwood JE, Dropulic LK, Seder RA; VRC 612 Part C Study Team. Lyke KE, et al. Among authors: happe m. Lancet Infect Dis. 2023 May;23(5):578-588. doi: 10.1016/S1473-3099(22)00793-9. Epub 2023 Jan 25. Lancet Infect Dis. 2023. PMID: 36708738 Free PMC article. Clinical Trial.
Safety and immunogenicity of a trivalent virus-like particle vaccine against western, eastern, and Venezuelan equine encephalitis viruses: a phase 1, open-label, dose-escalation, randomised clinical trial.
Coates EE, Edupuganti S, Chen GL, Happe M, Strom L, Widge A, Florez MB, Cox JH, Gordon I, Plummer S, Ola A, Yamshchikov G, Andrews C, Curate-Ingram S, Morgan P, Nagar S, Collins MH, Bray A, Nguyen T, Stein J, Case CL, Kaltovich F, Wycuff D, Liang CJ, Carlton K, Vazquez S, Mascola JR, Ledgerwood JE; VRC 313 Study Team. Coates EE, et al. Among authors: happe m. Lancet Infect Dis. 2022 Aug;22(8):1210-1220. doi: 10.1016/S1473-3099(22)00052-4. Epub 2022 May 11. Lancet Infect Dis. 2022. PMID: 35568049 Free PMC article. Clinical Trial.
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: happe m. EClinicalMedicine. 2022 Jun 1;48:101477. doi: 10.1016/j.eclinm.2022.101477. eCollection 2022 Jun. EClinicalMedicine. 2022. PMID: 35783486 Free PMC article.
Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria.
Wu RL, Idris AH, Berkowitz NM, Happe M, Gaudinski MR, Buettner C, Strom L, Awan SF, Holman LA, Mendoza F, Gordon IJ, Hu Z, Campos Chagas A, Wang LT, Da Silva Pereira L, Francica JR, Kisalu NK, Flynn BJ, Shi W, Kong WP, O'Connell S, Plummer SH, Beck A, McDermott A, Narpala SR, Serebryannyy L, Castro M, Silva R, Imam M, Pittman I, Hickman SP, McDougal AJ, Lukoskie AE, Murphy JR, Gall JG, Carlton K, Morgan P, Seo E, Stein JA, Vazquez S, Telscher S, Capparelli EV, Coates EE, Mascola JR, Ledgerwood JE, Dropulic LK, Seder RA; VRC 614 Study Team. Wu RL, et al. Among authors: happe m. N Engl J Med. 2022 Aug 4;387(5):397-407. doi: 10.1056/NEJMoa2203067. N Engl J Med. 2022. PMID: 35921449 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: happe m. 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.
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. Among authors: happe m. 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 Free PMC article. Clinical Trial.
Heterologous cAd3-Ebola and MVA-EbolaZ vaccines are safe and immunogenic in US and Uganda phase 1/1b trials.
Happe M, Hofstetter AR, Wang J, Yamshchikov GV, Holman LA, Novik L, Strom L, Kiweewa F, Wakabi S, Millard M, Kelley CF, Kabbani S, Edupuganti S, Beck A, Kaltovich F, Murray T, Tsukerman S, Carr D, Ashman C, Stanley DA, Ploquin A, Bailer RT, Schwartz R, Cham F, Tindikahwa A, Hu Z, Gordon IJ, Rouphael N, Houser KV, Coates EE, Graham BS, Koup RA, Mascola JR, Sullivan NJ, Robb ML, Ake JA, Lyke KE, Mulligan MJ, Ledgerwood JE, Kibuuka H; VRC 208 and RV 422 study team. Happe M, et al. NPJ Vaccines. 2024 Mar 29;9(1):67. doi: 10.1038/s41541-024-00833-z. NPJ Vaccines. 2024. PMID: 38553525 Free PMC article.
37 results