{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T23:22:08Z","timestamp":1793143328678,"version":"4.5.0"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2023,6,28]],"date-time":"2023-06-28T00:00:00Z","timestamp":1687910400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["HHSN272201300016I"],"award-info":[{"award-number":["HHSN272201300016I"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI148684"],"award-info":[{"award-number":["UM1AI148684"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,1,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Andes virus (ANDV), a rodent-borne hantavirus, causes hantavirus pulmonary syndrome (HPS). The safety and immunogenicity of a novel ANDV DNA vaccine was evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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 2 mg 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 4 mg 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>While 98% and 65% of subjects had at least 1 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This first-in-human candidate HPS vaccine trial demonstrated that an ANDV DNA vaccine was safe and induced a robust, durable immune response.<\/jats:p>\n                    <jats:p>Clinical Trials Registration.\u2003NCT03682107.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiad235","type":"journal-article","created":{"date-parts":[[2023,6,28]],"date-time":"2023-06-28T20:21:32Z","timestamp":1687983692000},"page":"30-38","source":"Crossref","is-referenced-by-count":41,"title":["Safety and Immunogenicity of an Andes Virus DNA Vaccine by Needle-Free Injection: A Randomized, Controlled Phase 1 Study"],"prefix":"10.1093","volume":"229","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8901-6513","authenticated-orcid":false,"given":"Grant C","family":"Paulsen","sequence":"first","affiliation":[{"name":"Division of Pediatric Infectious Diseases, Cincinnati Children\u2019s Hospital Medical Center , Cincinnati, OH , USA"},{"name":"Department of Pediatrics, University of Cincinnati College of Medicine , Cincinnati, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Robert","family":"Frenck","sequence":"additional","affiliation":[{"name":"Division of Pediatric Infectious Diseases, Cincinnati Children\u2019s Hospital Medical Center , Cincinnati, OH , USA"},{"name":"Department of Pediatrics, University of Cincinnati College of Medicine , Cincinnati, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kay M","family":"Tomashek","sequence":"additional","affiliation":[{"name":"Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodolfo M","family":"Alarcon","sequence":"additional","affiliation":[{"name":"Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Hensel","sequence":"additional","affiliation":[{"name":"The Emmes Company , Rockville, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley","family":"Lowe","sequence":"additional","affiliation":[{"name":"The Emmes Company , Rockville, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca L","family":"Brocato","sequence":"additional","affiliation":[{"name":"Virology Division, United States Army Medical Research Institute of 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