Casazza, Joseph P., Hofstetter, Amelia R., Costner, Pamela J.M., Holman, LaSonji A., Hendel, Cynthia S., Widge, Alicia T., Wu, Richard L., Whalen, William R., Cunningham, Jennifer, Arthur, Anita, Wang, Xiaolin, Ola, Abidemi, Saunders, Jamie, Mendoza, Floreliz, Novik, Laura, Burgos Florez, Maria C., Ortega-Villa, Ana M., Apte, Preeti J., Strom, Larisa, Wang, Lu, Imam, Marjaan, Basappa, Manjula, Naisan, Mursal, Castro, Mike, Trost, Jessica F., Narpala, Sandeep R., Vanderven, Hillary A., Yamshchikov, Galina V., Berkowitz, Nina M., Gordon, Ingelise J., Plummer, Sarah H., Wycuff, Diane L., Vazquez, Sandra, Gillespie, Rebecca A., Creanga, Adrian, Adams, William C., Carlton, Kevin, Gall, Jason G., McDermott, Adrian B., Serebryannyy, Leonid A., Houser, Katherine V., Koup, Richard A., Graham, Barney S., Ledgerwood, Julie E., Mascola, John R., Pierson, Theodore C., Andrews, Sarah F., Kanekiyo, Masaru, Dropulic, Lesia K., and The VRC 323 study team (2024) Phase 1 dose-escalation trial evaluating a group 2 influenza hemagglutinin stabilized stem nanoparticle vaccine. NPJ Vaccines, 9. 171.

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Abstract

The relative conservation of the influenza hemagglutinin (HA) stem compared to that of the immunodominant HA head makes the HA stem an attractive target for broadly protective influenza vaccines. Here we report the first-in-human, dose-escalation, open-label trial (NCT04579250) evaluating an unadjuvanted group 2 stabilized stem ferritin nanoparticle vaccine based on the H10 A/Jiangxi-Donghu/346/2013 influenza HA, H10ssF, in healthy adults. Participants received a single 20 mcg dose (n = 3) or two 60 mcg doses 16 weeks apart (n = 22). Vaccination with H10ssF was safe and well tolerated with only mild systemic and local reactogenicity reported. No serious adverse events occurred. Vaccination significantly increased homologous H10 HA stem binding and neutralizing antibodies at 2 weeks after both first and second vaccinations, and these responses remained above baseline at 40 weeks. Heterologous H3 and H7 binding antibodies also significantly increased after each vaccination and remained elevated throughout the study. These data indicate that the group 2 HA stem nanoparticle vaccine is safe and induces stem-directed binding and neutralizing antibodies.

Item ID:	84782
Item Type:	Article (Research - C1)
ISSN:	2059-0105
Copyright Information:	© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
Additional Information:	A list of The VRC 323 study team* authors and their affiliations appears at the end of the paper.
Date Deposited:	28 Feb 2025 03:08
FoR Codes:	32 BIOMEDICAL AND CLINICAL SCIENCES > 3204 Immunology > 320405 Humoural immunology and immunochemistry @ 75% 32 BIOMEDICAL AND CLINICAL SCIENCES > 3204 Immunology > 320402 Applied immunology (incl. antibody engineering, xenotransplantation and t-cell therapies) @ 25%
SEO Codes:	20 HEALTH > 2001 Clinical health > 200104 Prevention of human diseases and conditions @ 100%
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