Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial

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Edupuganti S, Hurt CB, Stephenson KE, Huang Y, Paez CA, Yu C, Yen C, Hanscom B, He Z, Miner MD, Gamble T, Heptinstall J, Seaton KE, Domin E, Lin BC, McKee K, Doria-Rose N, Regenold S, Spiegel H, Anderson M, McClosky N, Zhang L, Piwowar-Manning E, Ackerman ME, Pensiero M, Dye BJ, Landovitz RJ, Mayer K, Siegel M, Sobieszczyk M, Walsh SR, Gama L, Barouch DH, Montefiori DC, Tomaras GD; HVTN 136/HPTN 092 Study Team. Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial. Lancet HIV. 2025 Jan;12(1):e13-e25. doi: 10.1016/S2352-3018(24)00247-9. Epub 2024 Dec 10. PMID: 39667379; PMCID: PMC11795396.

Severe Acute Respiratory Syndrome Coronavirus 2 Household Transmission During the Omicron Era in Massachusetts: A Prospective, Case-Ascertained Study Using Genomic Epidemiology

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Banga, J., Brock-Fisher, T., Petros, B. A., Dai, E. Y., Leonelli, A. T., Dobbins, S. T., Messer, K. S., Nathanson, A. B., Capone, A., Littlehale, N., Appiah-Danquah, V., Dim, S., Moreno, G. K., Crowther, M., DeRuff, K. C., MacInnis, B. L., Springer, M., Sabeti, P. C., & Stephenson, K. E. (2024). Severe Acute Respiratory Syndrome Coronavirus 2 Household Transmission During the Omicron Era in Massachusetts: A Prospective, Case-Ascertained Study Using Genomic Epidemiology. Open forum infectious diseases, 11(11), ofae591. https://doi.org/10.1093/ofid/ofae591

Mosaic HIV-1 vaccine and SHIV challenge strain V2 loop sequence identity and protection in primates

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Vanshylla, K., Tolboom, J., Stephenson, K. E., Feddes-de Boer, K., Verwilligen, A., Rosendahl Huber, S. K., Rutten, L., Schuitemaker, H., Zahn, R. C., Barouch, D. H., & Wegmann, F. (2024). Mosaic HIV-1 vaccine and SHIV challenge strain V2 loop sequence identity and protection in primates. NPJ vaccines, 9(1), 179. https://doi.org/10.1038/s41541-024-00974-1

HIV Vaccine Development at a Crossroads: New B and T Cell Approaches

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Govindan, R., & Stephenson, K. E. (2024). HIV Vaccine Development at a Crossroads: New B and T Cell Approaches. Vaccines, 12(9), 1043. https://doi.org/10.3390/vaccines12091043

Safety and antiviral effect of a triple combination of HIV-1 broadly neutralizing antibodies: a phase 1/2a trial

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Julg B, Walker-Sperling VEK, Wagh K, Aid M, Stephenson KE, Zash R, Liu J, Nkolola JP, Hoyt A, Castro M, Serebryannyy L, Yanosick K, Speidel T, Borducchi EN, Murzda T, Maxfield L, Arduino R, McDermott AB, Gama L, Giorgi EE, Koup RA, Seaman MS, Rolle CP, DeJesus E, Li W, Korber B, Barouch DH. Safety and antiviral effect of a triple combination of HIV-1 broadly neutralizing antibodies: a phase 1/2a trial. Nat Med. 2024 Sep 12. doi: 10.1038/s41591-024-03247-5. Epub ahead of print. PMID: 39266747.

Patterns and predictors of COVID-19 vaccination among young adults at 44 US sites: Secondary analysis of a randomized, controlled, open-label trial, March – December 2021

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Vielot, N. A., Kelly, N. K., Ludema, C., Rosenberg, M., Brown, E. R., Janes, H. E., Kublin, J. G., Stephenson, K. E., Marcelin, J. R., & Pettifor, A. (2024). Patterns and predictors of COVID-19 vaccination among young adults at 44 US sites: Secondary analysis of a randomized, controlled, open-label trial, March – December 2021. Vaccine, 42(23), 126237. https://doi.org/10.1016/j.vaccine.2024.126237

Impact of LS Mutation on Pharmacokinetics of Preventive HIV Broadly Neutralizing Monoclonal Antibodies: A Cross-Protocol Analysis of 16 Clinical Trials in People without HIV

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Mayer BT, Zhang L, deCamp AC, Yu C, Sato A, Angier H, Seaton KE, Yates N, Ledgerwood JE, Mayer K, et al. Impact of LS Mutation on Pharmacokinetics of Preventive HIV Broadly Neutralizing Monoclonal Antibodies: A Cross-Protocol Analysis of 16 Clinical Trials in People without HIV. Pharmaceutics. 2024; 16(5):594. https://doi.org/10.3390/pharmaceutics16050594

Modeling resistance to the broadly neutralizing antibody PGT121 in people living with HIV-1

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Cassidy T, Stephenson KE, Barouch DH, Perelson AS (2024) Modeling resistance to the broadly neutralizing antibody PGT121 in people living with HIV-1. PLOS Computational Biology 20(3): e1011518. https://doi.org/10.1371/journal.pcbi.1011518

Efficacy of Messenger RNA–1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021

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Stephenson KE, Marcelin JR, Pettifor AE, Janes H, Brown E, Neradilek M, Yen C, Andriesen J, Grunenberg N, Espy N, Trahey M, Fischer RSB, DeSouza CA, Shisler JL, Connick E, Houpt ER, Chu HY, McCulloh RJ, Becker-Dreps S, Vielot NA, Kalbaugh CA, Cherabuddi K, Krueger KM, Rosenberg M, Greenberg RN, Joaquin A, Immergluck LC, Corey L, Kublin JG. Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021. Open Forum Infect Dis. 2023 Nov 2;10(11):ofad511. doi: 10.1093/ofid/ofad511. PMID: 38023544; PMCID: PMC10655942.

Activation of coagulation and proinflammatory pathways in thrombosis with thrombocytopenia syndrome and following COVID-19 vaccination

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Aid M, Stephenson KE, Collier AY, Nkolola JP, Michael JV, McKenzie SE, Barouch DH. Activation of coagulation and proinflammatory pathways in thrombosis with thrombocytopenia syndrome and following COVID-19 vaccination. Nat Commun. 2023 Oct 23;14(1):6703. doi: 10.1038/s41467-023-42559-x. PMID: 37872311; PMCID: PMC10593859.