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Safety/Immunogenicity Hantaan Virus DNA Vaccine and Puumala Virus DNA Vaccine, For Prevention of HFRS

NCT04333459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-19

No results posted yet for this study

Summary

A randomized 4 cohort study that is comparing the data collected during the earlier phase study and to determine if immunogenicity can be retained with a 1 mg dose of Hantaan DNA vaccine. The study is intended to substantiate the Phase 1 results with the 2 mg dose and to also determine if immunogenicity can be retained with a 1 mg dose (for HTNV DNA vaccine).

Conditions

  • Hantaan Virus Nephropathy
  • Puumala Virus Nephropathy

Interventions

BIOLOGICAL

Hantaan DNA Vaccine/Puumala DNA Vaccine

Vaccine compared in High and Low Doses.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Trevor Wellington, MD · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2024-10-15
Completion
2024-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04333459 on ClinicalTrials.gov