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181 results

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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: gay cl. medRxiv [Preprint]. 2024 Jan 11:2024.01.10.23299799. doi: 10.1101/2024.01.10.23299799. medRxiv. 2024. PMID: 38260276 Free PMC article. Preprint.
Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.
Turley CB, Tables L, Fuller T, Sanders LJ, Scott H, Moodley A, Woodward Davis A, Leav B, Miller J, Schoemaker K, Vandebosch A, Sadoff J, Woo W, Cho I, Dunkle LM, Li S, van der Laan L, Gilbert PB, Follmann D, Jaynes H, Kublin JG, Baden LR, Goepfert P, Kotloff K, Gay CL, Falsey AR, El Sahly HM, Sobieszczyk ME, Huang Y, Neuzil KM, Corey L, Grinsztejn B, Gray G, Rouphael N, Luedtke A; COVID-19 Prevention Network CoVPN. Turley CB, et al. Among authors: gay cl. Vaccine. 2023 Jul 25;41(33):4899-4906. doi: 10.1016/j.vaccine.2023.06.066. Epub 2023 Jun 23. Vaccine. 2023. PMID: 37385888 Free PMC article. Clinical Trial.
Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials.
Mena Lora AJ, Long JE, Huang Y, Baden LR, El Sahly HM, Follmann D, Goepfert P, Gray G, Grinsztejn B, Kotloff K, Rouphael N, Sobieszczyk M, Walsh SR, Andriesen J, Shah KA, Zhang Y, Gilbert P, Janes H, Gay CL, Falsey AR, Tripp RL, Gorman RL, Tong T, Marovich M, Neuzil K, Corey L, Kublin JG; COVID-19 Prevention Network. Mena Lora AJ, et al. Among authors: gay cl. JAMA Netw Open. 2023 Jan 3;6(1):e2251974. doi: 10.1001/jamanetworkopen.2022.51974. JAMA Netw Open. 2023. PMID: 36689221 Free PMC article.
Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial.
Áñez G, Dunkle LM, Gay CL, Kotloff KL, Adelglass JM, Essink B, Campbell JD, Cloney-Clark S, Zhu M, Plested JS, Roychoudhury P, Greninger AL, Patel N, McGarry A, Woo W, Cho I, Glenn GM, Dubovsky F; 2019nCoV-301 – Pediatric Expansion Study Group. Áñez G, et al. Among authors: gay cl. medRxiv [Preprint]. 2022 Sep 21:2022.09.20.22279903. doi: 10.1101/2022.09.20.22279903. medRxiv. 2022. PMID: 36172135 Free PMC article. Preprint.
A Novel Algorithm to Improve PrEP Adherence Monitoring Using Dried Blood Spots.
Devanathan AS, Dumond JB, Anderson DJC, Moody K, Poliseno AJ, Schauer AP, Sykes C, Gay CL, Rosen EP, Kashuba ADM, Cottrell ML. Devanathan AS, et al. Among authors: gay cl. Clin Pharmacol Ther. 2023 Apr;113(4):896-903. doi: 10.1002/cpt.2845. Epub 2023 Jan 31. Clin Pharmacol Ther. 2023. PMID: 36622798 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. Among authors: gay cl. 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.
Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial.
Fong Y, Huang Y, Benkeser D, Carpp LN, Áñez G, Woo W, McGarry A, Dunkle LM, Cho I, Houchens CR, Martins K, Jayashankar L, Castellino F, Petropoulos CJ, Leith A, Haugaard D, Webb B, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Randhawa AK, Andrasik MP, Kublin JG, Hutter J, Keshtkar-Jahromi M, Beresnev TH, Corey L, Neuzil KM, Follmann D, Ake JA, Gay CL, Kotloff KL, Koup RA, Donis RO, Gilbert PB; Immune Assays Team; Coronavirus Vaccine Prevention Network (CoVPN)/2019nCoV-301 Principal Investigators and Study Team; United States Government (USG)/CoVPN Biostatistics Team. Fong Y, et al. Among authors: gay cl. Nat Commun. 2023 Jan 19;14(1):331. doi: 10.1038/s41467-022-35768-3. Nat Commun. 2023. PMID: 36658109 Free PMC article.
Safety, Immunogenicity, and Efficacy of the NVX-CoV2373 COVID-19 Vaccine in Adolescents: A Randomized Clinical Trial.
Áñez G, Dunkle LM, Gay CL, Kotloff KL, Adelglass JM, Essink B, Campbell JD, Cloney-Clark S, Zhu M, Plested JS, Roychoudhury P, Greninger AL, Patel N, McGarry A, Woo W, Cho I, Glenn GM, Dubovsky F; 2019nCoV-301–Pediatric Expansion Study Group. Áñez G, et al. Among authors: gay cl. JAMA Netw Open. 2023 Apr 3;6(4):e239135. doi: 10.1001/jamanetworkopen.2023.9135. JAMA Netw Open. 2023. PMID: 37099299 Free PMC article. Clinical Trial.
SARS-CoV-2 Viral Load in the Nasopharynx at Time of First Infection Among Unvaccinated Individuals: A Secondary Cross-Protocol Analysis of 4 Randomized Trials.
Fisher LH, Kee JJ, Liu A, Espinosa CM, Randhawa AK, Ludwig J, Magaret CA, Robinson ST, Gilbert PB, Hyrien O, Kublin JG, Rouphael N, Falsey AR, Sobieszczyk ME, El Sahly HM, Grinsztejn B, Gray GE, Kotloff KL, Gay CL, Leav B, Hirsch I, Struyf F, Dunkle LM, Neuzil KM, Corey L, Huang Y, Goepfert PA, Walsh SR, Baden LR, Janes H; COVID-19 Prevention Network (CoVPN). Fisher LH, et al. Among authors: gay cl. JAMA Netw Open. 2024 May 1;7(5):e2412835. doi: 10.1001/jamanetworkopen.2024.12835. JAMA Netw Open. 2024. PMID: 38780941 Free PMC article.
Sequence Analysis of Inducible, Replication-Competent Virus Reveals No Evidence of HIV-1 Evolution During Suppressive Antiviral Therapy, Indicating a Lack of Ongoing Viral Replication.
Lee SK, Sondgeroth A, Xu Y, Warren J, Zhou S, Gilleece M, Hauser BM, Gay CL, Kuruc JD, Archin NM, Eron JJ, Margolis DM, Goonetilleke N, Swanstrom R. Lee SK, et al. Among authors: gay cl. Open Forum Infect Dis. 2024 Apr 17;11(5):ofae212. doi: 10.1093/ofid/ofae212. eCollection 2024 May. Open Forum Infect Dis. 2024. PMID: 38756763 Free PMC article.
181 results