Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age

Part of paid clinical trials in Miami, Florida.

Sponsor
Dynavax Technologies Corporation
Study ID
NCT07207408
Phase
PHASE2
Status
Recruiting
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Conditions

  • Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersenia Pestis

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • rF1V-1018 — BIOLOGICAL
    Regimen 1
  • rF1V-1018 — BIOLOGICAL
    Regimen 2
  • rF1V-1018 — BIOLOGICAL
    Regimen 3
  • rF1V-1018 — BIOLOGICAL
    Regimen 4
  • rF1V-1018 — BIOLOGICAL
    Regimen 5
  • rF1V-1018 — BIOLOGICAL
    Regimen 6

Study Details

This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine

Key Dates

Start date
Sep 11, 2025
Status verified
Oct 2025
Primary completion
May 29, 2026
Completion
Oct 16, 2026

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm 1
  • Experimental: Arm 2
  • Experimental: Arm 3
  • Experimental: Arm 4
  • Experimental: Arm 5
  • Experimental: Arm 6

Primary Outcome Measure

Anti-rF1V antibody level [ Time Frame: 4 weeks after final study vaccine ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
AMR- MiamiMiamiFlorida33134
Site Manager
[email protected]
305-445-5637
Abid Chaudhry (PRINCIPAL_INVESTIGATOR)
AMR- El DoradoEl DoradoKansas67042
Site Manager
[email protected]
316-600-5127
Michael Rausch (PRINCIPAL_INVESTIGATOR)
AMR- Las VegasLas VegasNevada889119
Site Manager
[email protected]
702-597-9825
Michael Jacobs (PRINCIPAL_INVESTIGATOR)

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AMR- Miami· Miami, FLAMR- El Dorado· El Dorado, KSAMR- Las Vegas· Las Vegas, NV