Phase 1 clinical trial of Hantaan and Puumala virus DNA vaccines delivered by needle-free injection
Jay W. Hooper, Steven A. Kwilas, Matthew Josleyn, Sarah L. Norris, Jack Hutter, Melinda Hamer, Jeffrey Livezey, Kristopher Paolino, Patrick Twomey, Michael Koren, Paul B. Keiser, James E. Moon, Ugo Nwaeze, Jason I. Koontz, Carmen Ledesma‐Feliciano, Nathalie Landry, Trevor Wellington
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%.