{"doi":"10.1093/infdis/jiad235","title":"Safety and Immunogenicity of an Andes Virus DNA Vaccine by Needle-Free Injection: A Randomized, Controlled Phase 1 Study","abstract":"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 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). RESULTS: 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. CONCLUSIONS: This first-in-human candidate HPS vaccine trial demonstrated that an ANDV DNA vaccine was safe and induced a robust, durable immune response. Clinical Trials Registration. NCT03682107.","journal":"The Journal of Infectious Diseases","year":2023,"id":327692,"datarank":0.67227018910882,"base_score":3.258096538021482,"endowment":3.258096538021482,"self_citation_contribution":0.4887144807032224,"citation_network_contribution":0.18355570840559762,"self_endowment_contribution":0.4887144807032224,"citer_contribution":0.18355570840559762,"corpus_percentile":null,"corpus_rank":null,"citation_count":25,"citer_count":21,"citers_with_citation_signal":8,"citers_with_endowment":8,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9536,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03682107"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":38190,"name":"Robert W. Frenck","orcid":"0000-0002-2336-526X","position":1,"is_corresponding":false},{"id":306901,"name":"Kay M. Tomashek","orcid":"0000-0001-7741-7072","position":2,"is_corresponding":false},{"id":1049087,"name":"Rodolfo Alarcón","orcid":null,"position":3,"is_corresponding":false},{"id":901971,"name":"Elizabeth Hensel","orcid":"0009-0009-1655-8926","position":4,"is_corresponding":false},{"id":667682,"name":"Ashley A. Lowe","orcid":"0000-0001-6252-0368","position":5,"is_corresponding":false},{"id":990734,"name":"Rebecca L. Brocato","orcid":"0000-0003-4377-0710","position":6,"is_corresponding":false},{"id":1049088,"name":"Steve Kwilas","orcid":null,"position":7,"is_corresponding":false},{"id":668818,"name":"Matthew Josleyn","orcid":null,"position":8,"is_corresponding":false},{"id":430282,"name":"Jay W. Hooper","orcid":"0000-0002-4475-0415","position":9,"is_corresponding":false},{"id":1048398,"name":"Grant Paulsen","orcid":"0000-0002-8901-6513","position":0,"is_corresponding":true}],"reference_count":26,"raw_metadata":null,"created_at":"2026-07-19T01:08:47.581262Z","pmid":"37380156","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}