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Your search keyword '"Conan-Cibotti, Michelle"' showing total 3 results
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3 results on '"Conan-Cibotti, Michelle"'

1. Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial

Author

Casazza, Joseph P., Cale, Evan M., Narpala, Sandeep, Yamshchikov, Galina V., Coates, Emily E., Hendel, Cynthia S., Novik, Laura, Holman, LaSonji A., Widge, Alicia T., Apte, Preeti, Gordon, Ingelise, Gaudinski, Martin R., Conan-Cibotti, Michelle, Lin, Bob C., Nason, Martha C., Trofymenko, Olga, Telscher, Shinyi, Plummer, Sarah H., Wycuff, Diane, Adams, William C., Pandey, Janardan P., McDermott, Adrian, Roederer, Mario, Sukienik, Avery N., O’Dell, Sijy, Gall, Jason G., Flach, Britta, Terry, Travis L., Choe, Misook, Shi, Wei, Chen, Xuejun, Kaltovich, Florence, Saunders, Kevin O., Stein, Judy A., Doria-Rose, Nicole A., Schwartz, Richard M., Balazs, Alejandro B., Baltimore, David, Nabel, Gary J., Koup, Richard A., Graham, Barney S., Ledgerwood, Julie E., and Mascola, John R.

Published
2022
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2. Safety and immunogenicity of an HIV-1 prefusion-stabilized envelope trimer (Trimer 4571) vaccine in healthy adults: A first-in-human open-label, randomized, dose-escalation, phase 1 clinical trial

Author

Houser, Katherine V., Gaudinski, Martin R., Happe, Myra, Narpala, Sandeep, Verardi, Raffaello, Sarfo, Edward K., Corrigan, Angela R., Wu, Richard, Rothwell, Ro Shauna, Novik, Laura, Hendel, Cynthia S., Gordon, Ingelise J., Berkowitz, Nina M., Cartagena, Cora Trelles, Widge, Alicia T., Coates, Emily E., Strom, Larisa, Hickman, Somia, Conan-Cibotti, Michelle, Vazquez, Sandra, Trofymenko, Olga, Plummer, Sarah, Stein, Judy, Case, Christopher L., Nason, Martha, Biju, Andrea, Parchment, Danealle K., Changela, Anita, Cheng, Cheng, Duan, Hongying, Geng, Hui, Teng, I-Ting, Zhou, Tongqing, O'Connell, Sarah, Barry, Chris, Carlton, Kevin, Gall, Jason G., Flach, Britta, Doria-Rose, Nicole A., Graham, Barney S., Koup, Richard A., McDermott, Adrian B., Mascola, John R., Kwong, Peter D., and Ledgerwood, Julie E.

Published
2022
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3. Phase 1 trial evaluating safety and pharmacokinetics of HIV-1 broadly neutralizing mAbs 10E8VLS and VRC07-523LS.

Author

Awan SF, Pegu A, Strom L, Carter CA, Hendel CS, Holman LA, Costner PJ, Trofymenko O, Dyer R, Gordon IJ, Rothwell RSS, Hickman SP, Conan-Cibotti M, Doria-Rose NA, Lin BC, O'Connell S, Narpala SR, Almasri CG, Liu C, Ko S, Kwon YD, Namboodiri AM, Pandey JP, Arnold FJ, Carlton K, Gall JG, Kwong PD, Capparelli EV, Bailer RT, McDermott AB, Chen GL, Koup RA, Mascola JR, Coates EE, Ledgerwood JE, and Gaudinski MR

Subjects
Humans, HIV Antibodies, Broadly Neutralizing Antibodies pharmacology, Antibodies, Monoclonal pharmacology, HIV Infections drug therapy, HIV Infections prevention & control, HIV-1, HIV Seropositivity
Abstract

BACKGROUNDBroadly neutralizing monoclonal antibodies (bNAbs) represent a promising strategy for HIV-1 immunoprophylaxis and treatment. 10E8VLS and VRC07-523LS are bNAbs that target the highly conserved membrane-proximal external region (MPER) and the CD4-binding site of the HIV-1 viral envelope glycoprotein, respectively.METHODSIn this phase 1, open-label trial, we evaluated the safety and pharmacokinetics of 5 mg/kg 10E8VLS administered alone, or concurrently with 5 mg/kg VRC07-523LS, via s.c. injection to healthy non-HIV-infected individuals.RESULTSEight participants received either 10E8VLS alone (n = 6) or 10E8VLS and VRC07-523LS in combination (n = 2). Five (n = 5 of 8, 62.5%) participants who received 10E8VLS experienced moderate local reactogenicity, and 1 participant (n = 1/8, 12.5%) experienced severe local reactogenicity. Further trial enrollment was stopped, and no participant received repeat dosing. All local reactogenicity resolved without sequelae. 10E8VLS retained its neutralizing capacity, and no functional anti-drug antibodies were detected; however, a serum t1/2 of 8.1 days was shorter than expected. Therefore, the trial was voluntarily stopped per sponsor decision (Vaccine Research Center, National Institute of Allergy and Infectious Diseases [NIAID], NIH). Mechanistic studies performed to investigate the underlying reason for the reactogenicity suggest that multiple mechanisms may have contributed, including antibody aggregation and upregulation of local inflammatory markers.CONCLUSION10E8VLS resulted in unexpected reactogenicity and a shorter t1/2 in comparison with previously tested bNAbs. These studies may facilitate identification of nonreactogenic second-generation MPER-targeting bNAbs, which could be an effective strategy for HIV-1 immunoprophylaxis and treatment.TRIAL REGISTRATIONClinicaltrials.gov, accession no. NCT03565315.FUNDINGDivision of Intramural Research, National Institute of Allergy and Infectious Diseases, NIH.

Published
2024
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