Abstract

Hantaan virus (HTNV) and Puumala virus (PUUV) are pathogenic zoonoses found in Asia and Europe, respectively. We conducted a randomized Phase 1 clinical trial of individual HTNV and PUUV DNA vaccines targeting the envelope glycoproteins (GnGc), as well as a combined HTNV/PUUV DNA vaccine delivered at varying doses using the PharmaJet Stratis® needle-free injection system (NCT02776761). Cohort 1 and 2 vaccines consisted of 2 mg/vaccination of HTNV or PUUV plasmid, respectively. Cohort 3 vaccine consisted of 2 mg/vaccination of 1:1 mixture of HTNV and PUUV vaccines. Vaccinations were administered on Days 0, 28, 56, and 168. The vaccines were safe and well tolerated. Neutralizing antibody responses were elicited in 7/7 (100%) subjects who received the HTNV DNA (Cohort 1) and 6/6 (100%) subjects who received the PUUV DNA (Cohort 2) vaccines alone. The combination vaccine resulted in 4/9 (44%) seroconversion against both viruses. After the first two vaccinations, the seroconversion rates for the HTNV and PUUV vaccines were >80%.

Details

Title
Phase 1 clinical trial of Hantaan and Puumala virus DNA vaccines delivered by needle-free injection
Author
Hooper, Jay W. 1 ; Kwilas, Steven A. 1   VIAFID ORCID Logo  ; Josleyn, Matthew 1 ; Norris, Sarah 1 ; Hutter, Jack N. 2 ; Hamer, Melinda 2 ; Livezey, Jeffrey 2 ; Paolino, Kristopher 2 ; Twomey, Patrick 2 ; Koren, Michael 2 ; Keiser, Paul 2 ; Moon, James E. 2 ; Nwaeze, Ugo 3 ; Koontz, Jason 3 ; Ledesma-Feliciano, Carmen 4 ; Landry, Nathalie 4 ; Wellington, Trevor 2 

1  United States Army Medical Research Institute of Infectious Diseases, Virology Division, Fort Detrick, USA (GRID:grid.416900.a) (ISNI:0000 0001 0666 4455) 
2  Walter Reed Army Institute of Research, Clinical Trials Center, Silver Spring, USA (GRID:grid.507680.c) (ISNI:0000 0001 2230 3166) 
3  US Army Medical Research and Development Command Office of Regulated Activities, Fort Detrick, USA (GRID:grid.420210.5) (ISNI:0000 0001 0036 4726) 
4  PharmaJet, Golden, USA (GRID:grid.491337.b) (ISNI:0000 0004 6008 4461) 
Pages
221
Publication year
2024
Publication date
2024
Publisher
Nature Publishing Group
e-ISSN
20590105
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1038/s41541-024-00998-7
ProQuest document ID
3129237695
Copyright
© This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.