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Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age

NCT05506969 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-29

Study results available
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Summary

Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age

Conditions

  • Plague, Pneumonic
  • Plague
  • Vaccine-Preventable Diseases

Interventions

BIOLOGICAL

rF1V-1018

rF1V vaccine and CpG 1018® adjuvant

BIOLOGICAL

rF1V vaccine

rF1V vaccine

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Dynavax Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Robert Janssen, MD · Dynavax Technologies Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2023-10-03
Completion
2024-04-26
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 NCT05506969 on ClinicalTrials.gov