NCT07207408

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

Phase 2, Randomized, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This dose-finding study will evaluate the immunogenicity, safety, and tolerability of multiple doses and regimens of rF1V-1018 vaccine in healthy adults. Immunogenicity blood samples will be drawn at several timepoints during the study. Participants will return to the clinic for periodic visits for study specific evaluations including evaluation of immunogenicity and safety. Safety assessments will be done at regular intervals through the end of the trial. Six dose regimens will be tested in Part 1 of the study. Up to two dose regimens from Part 1 will be chosen for Part 2 of the study.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	rF1V-1018	Regimen 1
BIOLOGICAL	rF1V-1018	Regimen 2
BIOLOGICAL	rF1V-1018	Regimen 3
BIOLOGICAL	rF1V-1018	Regimen 4
BIOLOGICAL	rF1V-1018	Regimen 5
BIOLOGICAL	rF1V-1018	Regimen 6

Timeline

• Start date: 2025-09-11
• Primary completion: 2026-05-29
• Completion: 2026-10-16
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study