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Page 1
Immune correlates analysis of the Imbokodo (HVTN 705/HPX2008) efficacy trial of a mosaic HIV-1 vaccine regimen evaluated in Southern African people assigned female sex at birth: a two-phase case-control study.
Kenny A, van Duijn J, Dintwe O, Heptinstall J, Burnham R, Sawant S, Zhang L, Mielke D, Khuzwayo S, Omar FL, Stanfield-Oakley S, Keyes T, Dunn B, Goodman D, Fong Y, Benkeser D, Zou R, Hural J, Hyrien O, Juraska M, Luedtke A, van der Laan L, Giorgi EE, Magaret C, Carpp LN, Pattacini L, van de Kerkhof T, Korber B, Willems W, Fisher LH, Schuitemaker H, Swann E, Kublin JG, Pau MG, Buchbinder S, Tomaka F, Nijs S, Lavreys L, Gelderblom HC, Corey L, Mngadi K, Gray GE, Borducchi E, Hendriks J, Seaton KE, Zolla-Pazner S, Barouch DH, Ferrari G, De Rosa SC, McElrath MJ, Andersen-Nissen E, Stieh DJ, Tomaras GD, Gilbert PB; Imbokodo Study and Correlates Group. Kenny A, et al. EBioMedicine. 2024 Oct;108:105320. doi: 10.1016/j.ebiom.2024.105320. Epub 2024 Sep 4. EBioMedicine. 2024. PMID: 39236556 Free PMC article. Clinical Trial.
Strengthening the Application of the DAIDS GCLP Guidelines: The Implementation of an Integrated Laboratory Oversight Framework.
Nguyen L, Leach A, Piwowar-Manning E, Marzinke M, Levesque A, Gregorio C, Skinner K, Towindo T, Hanes H, Sarpong K, Kasongo C, Samsunder N, Aldrovandi G, Ferbas KG, Engelbrecht A, Stirewalt M, Anyango E, Ubolyam S, Lankford-Turner P, Sarzotti-Kelsoe M. Nguyen L, et al. Among authors: sarzotti kelsoe m. AIDS Res Hum Retroviruses. 2024 Nov;40(11):622-630. doi: 10.1089/AID.2024.0042. Epub 2024 Sep 4. AIDS Res Hum Retroviruses. 2024. PMID: 39135473
Stochastic Interventional Vaccine Efficacy and Principal Surrogate Analyses of Antibody Markers as Correlates of Protection against Symptomatic COVID-19 in the COVE mRNA-1273 Trial.
Huang Y, Hejazi NS, Blette B, Carpp LN, Benkeser D, Montefiori DC, McDermott AB, Fong Y, Janes HE, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Kenny A, Carone M, Huynh C, Miller J, El Sahly HM, Baden LR, Jackson LA, Campbell TB, Clark J, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Pajon R, Follmann D, Donis RO, Koup RA, Gilbert PB, On Behalf Of The Immune Assays, Moderna Inc, Coronavirus Vaccine Prevention Network CoVPN/Coronavirus Efficacy Cove, United States Government Usg/CoVPN Biostatistics Teams. Huang Y, et al. Among authors: sarzotti kelsoe m. Viruses. 2023 Sep 29;15(10):2029. doi: 10.3390/v15102029. Viruses. 2023. PMID: 37896806 Free PMC article. Clinical Trial.
Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisition.
Seaton KE, Huang Y, Karuna S, Heptinstall JR, Brackett C, Chiong K, Zhang L, Yates NL, Sampson M, Rudnicki E, Juraska M, deCamp AC, Edlefsen PT, Mullins JI, Williamson C, Rossenkhan R, Giorgi EE, Kenny A, Angier H, Randhawa A, Weiner JA, Rojas M, Sarzotti-Kelsoe M, Zhang L, Sawant S, Ackerman ME, McDermott AB, Mascola JR, Hural J, McElrath MJ, Andrew P, Hidalgo JA, Clark J, Laher F, Orrell C, Frank I, Gonzales P, Edupuganti S, Mgodi N, Corey L, Morris L, Montefiori D, Cohen MS, Gilbert PB, Tomaras GD. Seaton KE, et al. Among authors: sarzotti kelsoe m. EBioMedicine. 2023 Jul;93:104590. doi: 10.1016/j.ebiom.2023.104590. Epub 2023 Jun 8. EBioMedicine. 2023. PMID: 37300931 Free PMC article.
H3N2 influenza hemagglutination inhibition method qualification with data driven statistical methods for human clinical trials.
Sawant S, Gurley SA, Overman RG, Sharak A, Mudrak SV, Oguin T 3rd, Sempowski GD, Sarzotti-Kelsoe M, Walter EB, Xie H, Pasetti MF, Moody MA, Tomaras GD. Sawant S, et al. Among authors: sarzotti kelsoe m. Front Immunol. 2023 Apr 6;14:1155880. doi: 10.3389/fimmu.2023.1155880. eCollection 2023. Front Immunol. 2023. PMID: 37090729 Free PMC article.
Comparing antibody assays as correlates of protection against COVID-19 in the COVE mRNA-1273 vaccine efficacy trial.
Benkeser D, Montefiori DC, McDermott AB, Fong Y, Janes HE, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Castellino F, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Kenny A, Carone M, Williamson BD, Garver J, Altonen E, Rudge T, Huynh C, Miller J, El Sahly HM, Baden LR, Frey S, Malkin E, Spector SA, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Carpp LN, Pajon R, Follmann D, Donis RO, Koup RA, Gilbert PB; Immune Assays; Moderna Inc.; Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE); United States Government (USG)/CoVPN Biostatistics Teams. Benkeser D, et al. Among authors: sarzotti kelsoe m. Sci Transl Med. 2023 Apr 19;15(692):eade9078. doi: 10.1126/scitranslmed.ade9078. Epub 2023 Apr 19. Sci Transl Med. 2023. PMID: 37075127 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: sarzotti kelsoe m. 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.
Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation.
Huang Y, Borisov O, Kee JJ, Carpp LN, Wrin T, Cai S, Sarzotti-Kelsoe M, McDanal C, Eaton A, Pajon R, Hural J, Posavad CM, Gill K, Karuna S, Corey L, McElrath MJ, Gilbert PB, Petropoulos CJ, Montefiori DC. Huang Y, et al. Among authors: sarzotti kelsoe m. Sci Rep. 2021 Dec 14;11(1):23921. doi: 10.1038/s41598-021-03154-6. Sci Rep. 2021. PMID: 34907214 Free PMC article.
Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.
Gilbert PB, Montefiori DC, McDermott AB, Fong Y, Benkeser D, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Castellino F, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Huynh C, Miller J, El Sahly HM, Baden LR, Baron M, De La Cruz L, Gay C, Kalams S, Kelley CF, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Carpp LN, Pajon R, Follmann D, Donis RO, Koup RA; Immune Assays Team§; Moderna, Inc. Team§; Coronavirus Vaccine Prevention Network (CoVPN)/Coronavirus Efficacy (COVE) Team§; United States Government (USG)/CoVPN Biostatistics Team§. Gilbert PB, et al. Among authors: sarzotti kelsoe m. Science. 2022 Jan 7;375(6576):43-50. doi: 10.1126/science.abm3425. Epub 2021 Nov 23. Science. 2022. PMID: 34812653 Free PMC article.
Calibration of Two Validated SARS-CoV-2 Pseudovirus Neutralization Assays for COVID-19 Vaccine Evaluation.
Huang Y, Borisov O, Kee JJ, Carpp LN, Wrin T, Cai S, Sarzotti-Kelsoe M, McDanal C, Eaton A, Pajon R, Hural J, Posavad CM, Gill K, Karuna S, Corey L, McElrath MJ, Gilbert PB, Petropoulos CJ, Montefiori DC. Huang Y, et al. Among authors: sarzotti kelsoe m. medRxiv [Preprint]. 2021 Sep 14:2021.09.09.21263049. doi: 10.1101/2021.09.09.21263049. medRxiv. 2021. Update in: Sci Rep. 2021 Dec 14;11(1):23921. doi: 10.1038/s41598-021-03154-6 PMID: 34545372 Free PMC article. Updated. Preprint.
39 results