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A community-partnered approach for diversity in COVID-19 vaccine clinical trials.
Castellon-Lopez Y, Landovitz R, Ntekume E, Porter C, Bross R, Hilder R, Lucas-Wright A, Daar ES, Chavez P, Blades C, Carson S, Morris D, Vassar S, Casillas A, Brown A. Castellon-Lopez Y, et al. Among authors: blades c. J Clin Transl Sci. 2022 Oct 6;7(1):e23. doi: 10.1017/cts.2022.471. eCollection 2023. J Clin Transl Sci. 2022. PMID: 36714798 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. 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.
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. 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.
Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition.
Corey L, Gilbert PB, Juraska M, Montefiori DC, Morris L, Karuna ST, Edupuganti S, Mgodi NM, deCamp AC, Rudnicki E, Huang Y, Gonzales P, Cabello R, Orrell C, Lama JR, Laher F, Lazarus EM, Sanchez J, Frank I, Hinojosa J, Sobieszczyk ME, Marshall KE, Mukwekwerere PG, Makhema J, Baden LR, Mullins JI, Williamson C, Hural J, McElrath MJ, Bentley C, Takuva S, Gomez Lorenzo MM, Burns DN, Espy N, Randhawa AK, Kochar N, Piwowar-Manning E, Donnell DJ, Sista N, Andrew P, Kublin JG, Gray G, Ledgerwood JE, Mascola JR, Cohen MS; HVTN 704/HPTN 085 and HVTN 703/HPTN 081 Study Teams. Corey L, et al. N Engl J Med. 2021 Mar 18;384(11):1003-1014. doi: 10.1056/NEJMoa2031738. N Engl J Med. 2021. PMID: 33730454 Free PMC article. Clinical Trial.
WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019.
Sheets R, Kang HN, Meyer H, Knezevic I; WHO informal consultation on development of guidelines for assuring the quality, safety, and efficacy of DNA vaccine. Sheets R, et al. NPJ Vaccines. 2020 Jun 18;5(1):52. doi: 10.1038/s41541-020-0197-2. eCollection 2020. NPJ Vaccines. 2020. PMID: 32579135 Free PMC article.
WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Wadhwa M, Kang HN, Jivapaisarnpong T; WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products; Andalucia LR, Blades CDRZ, Casas Levano M, Chang W, Chew JY, Chilufya MB, Chirachanakul P, Cho HG, Cho YO, Choi KM, Chong S, Chua HM, Farahani AV, Gencoglu M, Ghobrial MRW, Guha P, Gutierrez Lugo MT, Ha SB, Habahbeh S, Hamel H, Hong Y, Iarutkin A, Jang H, Jayachandran R, Jivapaisarnpong T, Kang HN, Kim DY, Kim GH, Kim Y, Kwon HS, Larsen J, Lee AH, Lee J, Medvedeva K, Munkombwe Z, Oh I, Park J, Park J, Putri DE, Rodgers J, Ryu S, Savkina M, Schreitmueller T, Semeniuk O, Seo M, Shin YI, Shin J, Srivastava S, Song H, Song S, Tavares Neto J, Wadhwa M, Yamaguchi T, Youn HD, Yun M. Wadhwa M, et al. Among authors: blades cdrz. Biologicals. 2020 May;65:50-59. doi: 10.1016/j.biologicals.2019.12.008. Epub 2020 Jan 17. Biologicals. 2020. PMID: 31959504
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