Evidence map›Paper›PMID 37380156›Full record

Trial reportThe Journal of infectious diseases2024

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

Grant C Paulsen, Robert Frenck, Kay M Tomashek, Rodolfo M Alarcon, Elizabeth Hensel, Ashley Lowe, Rebecca L Brocato, Steve A Kwilas, Matthew D Josleyn, Jay W Hooper

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03682107 (A Phase I, Randomized, Placebo Controlled, Double-Blind, Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03682107 phase1completednot on this map

A Phase I, Randomized, Placebo Controlled, Double-Blind, Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection System in Normal Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2019 to 2020Enrolled48ConditionsHantavirus Pulmonary Infection, ImmunisationArmsAndes virus DNA vaccine, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 15 citations in OpenAlex.

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  13. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Grant C PaulsenDivision of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.ORCID 0000-0002-8901-6513
Robert FrenckDivision of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Kay M TomashekDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Rodolfo M AlarconDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Elizabeth HenselThe Emmes Company, Rockville, Maryland, USA.
Ashley LoweThe Emmes Company, Rockville, Maryland, USA.
Rebecca L BrocatoVirology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland, USA.
Steve A KwilasVirology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland, USA.
Matthew D JosleynVirology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland, USA.
Jay W HooperVirology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland, USA.
United States Army Medical Research Institute of Infectious Diseases · USCincinnati Children's Hospital Medical Center · USEmmes (United States) · USNational Institutes of Health · US

Funding

Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG) - Momi-Vax DMID #21-0004 {Supplement #6}UM1AI148684 · NIAID · EMORY UNIVERSITY · PI DAVID S STEPHENS · 2020 to 2026
$77.2M
Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required) - Moderna Pediatric StudyUM1AI148372 · NIAID · CINCINNATI CHILDRENS HOSP MED CTR · PI Robert Wilson Frenck · 2020 to 2026
$20.5M
NIAID NIH HHS HHSN272201300016CNIAID NIH HHS HHSN272201300016INIAID NIH HHS UM1 AI148372NIAID NIH HHS UM1 AI148684NIH HHS HHSN272201300016I
6 · The paper itself

Abstract

backgroundAndes virus (ANDV), a rodent-borne hantavirus, causes hantavirus pulmonary syndrome (HPS). The safety and immunogenicity of a novel ANDV DNA vaccine was evaluated.

methodsPhase 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).

resultsWhile 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.

conclusionsThis 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.

Indexed as

Hantavirus Pulmonary SyndromeOrthohantavirusVaccines, DNAAdultAntibodies, NeutralizingAntibodies, ViralDNADouble-Blind MethodHumansImmunogenicity, VaccineAntibodies, NeutralizingAntibodies, ViralDNAVaccines, DNAAndesDNA vaccinehantavirushantavirus pulmonary syndromeneedle-free injection

Identifiers

PMID37380156
PMCPMC10786244
OpenAlexW4382501375

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.