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

Conditions

• Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersinia 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

First listed

Oct 6, 2025

Start date

Sep 11, 2025

Status verified

Jun 2026

Primary completion

Jan 29, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

148 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Part 1 Arm 1
• Experimental: Part 1 Arm 2
• Experimental: Part 1 and Part 2: Arm 3
  This Part 1 arm was selected for Part 2.
• Experimental: Part 1 and Part 2: Arm 4
  This Part 1 arm was selected for Part 2.
• Experimental: Part 1 Arm 5
• Experimental: Part 1 Arm 6

Primary Outcome Measure

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

Central Contacts

• Ouzama Henry, MD, Vice President, Clinical Development
  510-848-5100
  [email protected]

Locations (4)

Find similar trials in Miami, FL