Vaccination with mRNA-encoded membrane-anchored HIV envelope trimers elicited tier 2 neutralizing antibodies in a phase 1 clinical trial

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Parks KR, Moodie Z, Allen MA, Yen C, Furch BD, MacPhee KJ, Ozorowski G, Heptinstall J, Hahn WO, Zheng Z, Lu H, Grant S, Domin E, Duff MO, Seese A, Marini-Macouzet C, Ballweber-Fleming L, Lee WH, Cottrell CA, Liguori A, Georgeson E, Alavi N, Kubitz M, Phelps N, Seaton KE, Cohen KW, Anderson MA, Mondal K, Laufer DS, Kublin JG, Ward AB, Hyrien O, De Rosa SC, Himansu S, Leav B, Reuter C, Tomaras GD, Montefiori D, Walsh SR, Frank I, Sobieszczyk ME, Goepfert PA, Stephenson KE, Baden LR, Van Tieu H, Keefer MC, Clark J, Riddler SA, Schief WR, McElrath MJ. Vaccination with mRNA-encoded membrane-anchored HIV envelope trimers elicited tier 2 neutralizing antibodies in a phase 1 clinical trial. Science Translational Medicine. 2025 Jul 30;17(809):eady6831. doi: 10.1126/scitranslmed.ady6831.

High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302)

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Riddler SA, Moodie Z, Clark J, Yen C, Allen M, Furch BD, Lu H, Grant S, Mondal K, Anderson M, Maenza J, Lemos MP, Woodward Davis AS, Walsh SR, Sobieszczyk ME, Frank I, Goepfert P, Stephenson KE, Baden LR, Tieu HV, Keefer MC, McElrath MJ, Kublin JG, Corey L. High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302). Annals to Internal Medicine. 2025 Jul;178(7):963-974. doi: 10.7326/ANNALS-24-02701.

Fixed dosing versus weight-based dosing of HIV-1 prophylactic monoclonal antibodies in adults: a post-hoc, cross-protocol pharmacokinetics modelling study

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Huang Y, Zhang L, Gelderblom H, Seaton KE, Yates NL, Paez CA, Karuna ST, Andrew P, Gamble T, Robinson ST, Ledgerwood JE, Hyrien O, Walsh SR, Gay CL, Gwira JA, Spiegel HML, Sobieszczyk ME, Mannheimer SB, Edupuganti S, Hurt CB, Stephenson KE, Yu C, Kelley CF, Mahomed S, Siegel M, Yacovone M, Pensiero MN, Donnell D, Cohen MS, Corey L, Gilbert PB, Koup RA, Tomaras GD; VRC 605, HVTN 127/HPTN 087, HVTN 130/HPTN 089, HVTN 136/HPTN 092, and HVTN 140/HPTN 101 study teams. Fixed dosing versus weight-based dosing of HIV-1 prophylactic monoclonal antibodies in adults: a post-hoc, cross-protocol pharmacokinetics modelling study. EBioMedicine. 2025 Jul;117:105804. doi: 10.1016/j.ebiom.2025.105804. Epub 2025 Jun 13.

Next-Generation Coronavirus Disease 2019 Vaccines: Clinical Data and Future Directions

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Stephenson K. E. (2025). Next-Generation Coronavirus Disease 2019 Vaccines: Clinical Data and Future Directions. Infectious disease clinics of North America, 39(2), 253–274. https://doi.org/10.1016/j.idc.2025.02.003

Pharmacokinetic interaction assessment of an HIV broadly neutralizing monoclonal antibody VRC07-523LS: a cross-protocol analysis of three phase 1 trials in people without HIV

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Chawana, T. D., Walsh, S. R., Stranix-Chibanda, L., Chirenje, Z. M., Yu, C., Zhang, L., Seaton, K. E., Heptinstall, J., Zhang, L., Paez, C. A., Gamble, T., Karuna, S. T., Andrew, P., Hanscom, B., Sobieszczyk, M. E., Edupuganti, S., Gay, C. L., Mannheimer, S. B., Hurt, C. B., Stephenson, K. E., … HVTN 127/HPTN 087, HVTN 130/HPTN 089 and HVTN 136/HPTN 092 Study Teams (2025). Pharmacokinetic interaction assessment of an HIV broadly neutralizing monoclonal antibody VRC07-523LS: a cross-protocol analysis of three phase 1 trials in people without HIV. BMC immunology, 26(1), 8. https://doi.org/10.1186/s12865-025-00687-7

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.