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Page 1
Infusion Reactions After Receiving the Broadly Neutralizing Antibody VRC01 or Placebo to Reduce HIV-1 Acquisition: Results From the Phase 2b Antibody-Mediated Prevention Randomized Trials.
Takuva S, Karuna ST, Juraska M, Rudnicki E, Edupuganti S, Anderson M, De La Grecca R, Gaudinski MR, Sehurutshi A, Orrell C, Naidoo L, Valencia J, Villela LM, Walsh SR, Andrew P, Karg C, Randhawa A, Hural J, Gomez Lorenzo MM, Burns DN, Ledgerwood J, Mascola JR, Cohen M, Corey L, Mngadi K, Mgodi NM; HVTN 703/HPTN 081 and HVTN 704/HPTN 085 Study Teams. Takuva S, et al. Among authors: rudnicki e. J Acquir Immune Defic Syndr. 2022 Apr 1;89(4):405-413. doi: 10.1097/QAI.0000000000002892. J Acquir Immune Defic Syndr. 2022. PMID: 34923559 Free PMC article. Clinical Trial.
Pharmacokinetics and predicted neutralisation coverage of VRC01 in HIV-uninfected participants of the Antibody Mediated Prevention (AMP) trials.
Huang Y, Naidoo L, Zhang L, Carpp LN, Rudnicki E, Randhawa A, Gonzales P, McDermott A, Ledgerwood J, Lorenzo MMG, Burns D, DeCamp A, Juraska M, Mascola J, Edupuganti S, Mgodi N, Cohen M, Corey L, Andrew P, Karuna S, Gilbert PB, Mngadi K, Lazarus E. Huang Y, et al. Among authors: rudnicki e. EBioMedicine. 2021 Feb;64:103203. doi: 10.1016/j.ebiom.2020.103203. Epub 2021 Jan 23. EBioMedicine. 2021. PMID: 33493795 Free PMC article. Clinical Trial.
Feasibility and Successful Enrollment in a Proof-of-Concept HIV Prevention Trial of VRC01, a Broadly Neutralizing HIV-1 Monoclonal Antibody.
Edupuganti S, Mgodi N, Karuna ST, Andrew P, Rudnicki E, Kochar N, deCamp A, De La Grecca R, Anderson M, Karg C, Tindale I, Greene E, Broder GB, Lucas J, Hural J, Gallardo-Cartagena JA, Gonzales P, Frank I, Sobieszczyk M, Gomez Lorenzo MM, Burns D, Anderson PL, Miner MD, Ledgerwood J, Mascola JR, Gilbert PB, Cohen MS, Corey L; HVTN 704/HPTN 085 study group. Edupuganti S, et al. Among authors: rudnicki e. J Acquir Immune Defic Syndr. 2021 May 1;87(1):671-679. doi: 10.1097/QAI.0000000000002639. J Acquir Immune Defic Syndr. 2021. PMID: 33587505 Free PMC article. Clinical Trial.
A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection in Women in Sub-Saharan Africa: Baseline Findings.
Mgodi NM, Takuva S, Edupuganti S, Karuna S, Andrew P, Lazarus E, Garnett P, Shava E, Mukwekwerere PG, Kochar N, Marshall K, Rudnicki E, Juraska M, Anderson M, Karg C, Tindale I, Greene E, Luthuli N, Baepanye K, Hural J, Gomez Lorenzo MM, Burns D, Miner MD, Ledgerwood J, Mascola JR, Donnell D, Cohen MS, Corey L; HVTN 703/HPTN 081 Team. Mgodi NM, et al. Among authors: rudnicki e. J Acquir Immune Defic Syndr. 2021 May 1;87(1):680-687. doi: 10.1097/QAI.0000000000002649. J Acquir Immune Defic Syndr. 2021. PMID: 33587510 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. Among authors: rudnicki e. 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.
Prediction of serum HIV-1 neutralization titers of VRC01 in HIV-uninfected Antibody Mediated Prevention (AMP) trial participants.
Huang Y, Zhang L, Eaton A, Mkhize NN, Carpp LN, Rudnicki E, DeCamp A, Juraska M, Randhawa A, McDermott A, Ledgerwood J, Andrew P, Karuna S, Edupuganti S, Mgodi N, Cohen M, Corey L, Mascola J, Gilbert PB, Morris L, Montefiori DC. Huang Y, et al. Among authors: rudnicki e. Hum Vaccin Immunother. 2022 Dec 31;18(1):1908030. doi: 10.1080/21645515.2021.1908030. Epub 2021 Jul 2. Hum Vaccin Immunother. 2022. PMID: 34213402 Free PMC article.
Neutralization titer biomarker for antibody-mediated prevention of HIV-1 acquisition.
Gilbert PB, Huang Y, deCamp AC, Karuna S, Zhang Y, Magaret CA, Giorgi EE, Korber B, Edlefsen PT, Rossenkhan R, Juraska M, Rudnicki E, Kochar N, Huang Y, Carpp LN, Barouch DH, Mkhize NN, Hermanus T, Kgagudi P, Bekker V, Kaldine H, Mapengo RE, Eaton A, Domin E, West C, Feng W, Tang H, Seaton KE, Heptinstall J, Brackett C, Chiong K, Tomaras GD, Andrew P, Mayer BT, Reeves DB, Sobieszczyk ME, Garrett N, Sanchez J, Gay C, Makhema J, Williamson C, Mullins JI, Hural J, Cohen MS, Corey L, Montefiori DC, Morris L. Gilbert PB, et al. Among authors: rudnicki e. Nat Med. 2022 Sep;28(9):1924-1932. doi: 10.1038/s41591-022-01953-6. Epub 2022 Aug 22. Nat Med. 2022. PMID: 35995954 Free PMC article.
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: rudnicki e. EBioMedicine. 2023 Jul;93:104590. doi: 10.1016/j.ebiom.2023.104590. Epub 2023 Jun 8. EBioMedicine. 2023. PMID: 37300931 Free PMC article.
Prevention efficacy of the broadly neutralizing antibody VRC01 depends on HIV-1 envelope sequence features.
Juraska M, Bai H, deCamp AC, Magaret CA, Li L, Gillespie K, Carpp LN, Giorgi EE, Ludwig J, Molitor C, Hudson A, Williamson BD, Espy N, Simpkins B, Rudnicki E, Shao D, Rossenkhan R, Edlefsen PT, Westfall DH, Deng W, Chen L, Zhao H, Bhattacharya T, Pankow A, Murrell B, Yssel A, Matten D, York T, Beaume N, Gwashu-Nyangiwe A, Ndabambi N, Thebus R, Karuna ST, Morris L, Montefiori DC, Hural JA, Cohen MS, Corey L, Rolland M, Gilbert PB, Williamson C, Mullins JI. Juraska M, et al. Among authors: rudnicki e. Proc Natl Acad Sci U S A. 2024 Jan 23;121(4):e2308942121. doi: 10.1073/pnas.2308942121. Epub 2024 Jan 19. Proc Natl Acad Sci U S A. 2024. PMID: 38241441
15 results