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Safety and Immunogenicity of an Andes Virus DNA Vaccine by Needle-Free Injection: a Randomized, Controlled Phase 1 Study.

2023 Jun 28

Journal Article

Paulsen, G.C.; Frenck, R.; Tomashek, K.M.; Alarcon, R.M.; Hensel, E.; Lowe, A.; Brocato, R.L.; Kwilas, S.A.; Josleyn, M.D.; Hooper, J.W.

J Infect Dis




Andes; DNA; Hantavirus; needle-free injection; Pulmonary; syndrome; vaccine

BACKGROUND: Andes virus (ANDV), a rodent-borne hantavirus, causes hantavirus pulmonary syndrome (HPS). The safety and immunogenicity of a novel ANDV DNA vaccine was evaluated.METHODS: Phase 1, double-blind, dose-escalation trial randomly assigned 48 healthy adults to placebo or ANDV DNA vaccine delivered via needle-free jet injection. Cohorts 1 and 2 received 2mg of DNA or placebo in a 3-dose (days 1, 29, 169) or 4-dose (days 1, 29, 57, 169) schedule, respectively. Cohorts 3 and 4 received 4mg of DNA or placebo in the 3-dose and 4-dose schedule, respectively. Subjects were monitored for safety and neutralizing antibodies by pseudovirion neutralization assay (PsVNA50) and plaque reduction neutralization test (PRNT50).RESULTS: While 98% and 65% of subjects had at least one local or systemic solicited adverse event (AE), respectively, most AEs were mild or moderate; no related serious AEs were detected. Cohorts 2, 3 and 4 had higher seroconversion rates than Cohort 1 and seropositivity of at least 80% by day 197; sustained through day 337. PsVNA50 geometric mean titers were highest for Cohort 4 on and after day 197.CONCLUSIONS: This first-in-human candidate HPS vaccine trial demonstrated that an ANDV DNA vaccine was safe and induced a robust, durable immune response.

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