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A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats.
Longini IM, Yang Y, Fleming TR, Muñoz-Fontela C, Wang R, Ellenberg SS, Qian G, Halloran ME, Nason M, Gruttola V, Mulangu S, Huang Y, Donnelly CA, Henao Restrepo AM. Longini IM, et al. Among authors: huang y. Clin Trials. 2022 Dec;19(6):647-654. doi: 10.1177/17407745221110880. Epub 2022 Jul 22. Clin Trials. 2022. PMID: 35866633 Free PMC article. Clinical Trial.
Use of placebos in Phase 1 preventive HIV vaccine clinical trials.
Huang Y, Karuna ST, Janes H, Frahm N, Nason M, Edlefsen PT, Kublin JG, Corey L, McElrath MJ, Gilbert PB. Huang Y, et al. Vaccine. 2015 Feb 4;33(6):749-52. doi: 10.1016/j.vaccine.2014.10.017. Epub 2014 Oct 23. Vaccine. 2015. PMID: 25454855 Free PMC article.
Effect of rAd5-Vector HIV-1 Preventive Vaccines on HIV-1 Acquisition: A Participant-Level Meta-Analysis of Randomized Trials.
Huang Y, Follmann D, Nason M, Zhang L, Huang Y, Mehrotra DV, Moodie Z, Metch B, Janes H, Keefer MC, Churchyard G, Robb ML, Fast PE, Duerr A, McElrath MJ, Corey L, Mascola JR, Graham BS, Sobieszczyk ME, Kublin JG, Robertson M, Hammer SM, Gray GE, Buchbinder SP, Gilbert PB. Huang Y, et al. PLoS One. 2015 Sep 2;10(9):e0136626. doi: 10.1371/journal.pone.0136626. eCollection 2015. PLoS One. 2015. PMID: 26332672 Free PMC article.
COVID-19 vaccine trials should seek worthwhile efficacy.
Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R; World Health Organization Solidarity Vaccines Trial Expert Group. Krause P, et al. Lancet. 2020 Sep 12;396(10253):741-743. doi: 10.1016/S0140-6736(20)31821-3. Epub 2020 Aug 27. Lancet. 2020. PMID: 32861315 Free PMC article. No abstract available.
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: huang y. 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.
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: huang y. 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 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. 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: huang y. Nat Commun. 2023 Jan 19;14(1):331. doi: 10.1038/s41467-022-35768-3. Nat Commun. 2023. PMID: 36658109 Free PMC article.
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: huang y. JAMA Netw Open. 2023 Jan 3;6(1):e2251974. doi: 10.1001/jamanetworkopen.2022.51974. JAMA Netw Open. 2023. PMID: 36689221 Free PMC article.
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