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Page 1
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.
Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials.
Gilbert PB, Juraska M, deCamp AC, Karuna S, Edupuganti S, Mgodi N, Donnell DJ, Bentley C, Sista N, Andrew P, Isaacs A, Huang Y, Zhang L, Capparelli E, Kochar N, Wang J, Eshleman SH, Mayer KH, Magaret CA, Hural J, Kublin JG, Gray G, Montefiori DC, Gomez MM, Burns DN, McElrath J, Ledgerwood J, Graham BS, Mascola JR, Cohen M, Corey L. Gilbert PB, et al. Among authors: huang y. Stat Commun Infect Dis. 2017 Jan;9(1):20160001. doi: 10.1515/scid-2016-0001. Epub 2017 Jun 6. Stat Commun Infect Dis. 2017. PMID: 29218117 Free PMC article.
Combining Viral Genetics and Statistical Modeling to Improve HIV-1 Time-of-infection Estimation towards Enhanced Vaccine Efficacy Assessment.
Rossenkhan R, Rolland M, Labuschagne JPL, Ferreira RC, Magaret CA, Carpp LN, Matsen Iv FA, Huang Y, Rudnicki EE, Zhang Y, Ndabambi N, Logan M, Holzman T, Abrahams MR, Anthony C, Tovanabutra S, Warth C, Botha G, Matten D, Nitayaphan S, Kibuuka H, Sawe FK, Chopera D, Eller LA, Travers S, Robb ML, Williamson C, Gilbert PB, Edlefsen PT. Rossenkhan R, et al. Among authors: huang y. Viruses. 2019 Jul 3;11(7):607. doi: 10.3390/v11070607. Viruses. 2019. PMID: 31277299 Free PMC article.
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.
Assessing Durability of Vaccine Effect Following Blinded Crossover in COVID-19 Vaccine Efficacy Trials.
Follmann D, Fintzi J, Fay MP, Janes HE, Baden L, Sahly HE, 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. medRxiv [Preprint]. 2020 Dec 14:2020.12.14.20248137. doi: 10.1101/2020.12.14.20248137. medRxiv. 2020. PMID: 33336213 Free PMC article. Updated. Preprint.
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.
Analysis of the HIV Vaccine Trials Network 702 Phase 2b-3 HIV-1 Vaccine Trial in South Africa Assessing RV144 Antibody and T-Cell Correlates of HIV-1 Acquisition Risk.
Moodie Z, Dintwe O, Sawant S, Grove D, Huang Y, Janes H, Heptinstall J, Omar FL, Cohen K, De Rosa SC, Zhang L, Yates NL, Sarzotti-Kelsoe M, Seaton KE, Laher F, Bekker LG, Malahleha M, Innes C, Kassim S, Naicker N, Govender V, Sebe M, Singh N, Kotze P, Lazarus E, Nchabeleng M, Ward AM, Brumskine W, Dubula T, Randhawa AK, Grunenberg N, Hural J, Kee JJ, Benkeser D, Jin Y, Carpp LN, Allen M, D'Souza P, Tartaglia J, DiazGranados CA, Koutsoukos M, Gilbert PB, Kublin JG, Corey L, Andersen-Nissen E, Gray GE, Tomaras GD, McElrath MJ. Moodie Z, et al. Among authors: huang y. J Infect Dis. 2022 Aug 24;226(2):246-257. doi: 10.1093/infdis/jiac260. J Infect Dis. 2022. PMID: 35758878 Free PMC article. Clinical Trial.
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