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

NCT07207408 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: DV2-DC02-02
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersenia Pestis

Outcome Measures

Primary Outcomes (2)

• Anti-rF1V antibody level

  4 weeks after final study vaccine

• Evaluate safety of rF1V-1018

  Evaluate adverse events

  injection reactions through 7 days after each study vaccine, adverse events for 28 days after each study vaccine; SAEs, MAEs, imAESIs through 6 months after the final study vaccine

Study Arms (6)

Arm 1

EXPERIMENTAL

Biological: rF1V-1018

Arm 2

EXPERIMENTAL

Biological: rF1V-1018

Arm 3

EXPERIMENTAL

Biological: rF1V-1018

Arm 4

EXPERIMENTAL

Biological: rF1V-1018

Arm 5

EXPERIMENTAL

Biological: rF1V-1018

Arm 6

EXPERIMENTAL

Biological: rF1V-1018

Interventions

rF1V-1018 BIOLOGICAL

Regimen 1

Arm 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults 18 to 55 years of age
• Healthy participants or participants with stable pre-existing medical conditions Pre-existing stable medical condition means a participant who: has full capacity of daily activity and no major medication modification within 3 months prior to Day 1; has not undergone surgical or minimally-invasive intervention or had any hospitalization/emergency room visit for the specific medical condition.
• Able to comply with the protocol schedule and procedures
• Able and willing to provide written informed consent
• If female of child-bearing potential and heterosexually active, has practiced adequate contraception for at least 28 days prior to vaccination, has negative pregnancy tests just prior to vaccination, and has agreed to continue adequate contraception through three months following the final trial injection
• A premenopausal woman who has at least one of the following is considered not of childbearing potential:
• Documented hysterectomy
• Documented bilateral salpingectomy
• Documented bilateral oophorectomy
• Documented and current bilateral tubal ligation or occlusion

You may not qualify if:

• A history of plague disease or have previously received any plague vaccine
• Active tuberculosis or other systemic infectious process
• History of human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) infection, or positive test for antibody to HIV, HBV, or HCV
• History of autoimmune disorder
• History of sensitivity to any component of trial vaccines
• Body mass index ≥ 30 kg/m2
• Has received the following prior to any trial injection:
• a) ≤ 14 days: i) Any licensed or authorized inactivated vaccines (including vaccines containing mRNA or CpG) b) ≤ 28 days: i) Any live vaccine ii) Any investigational medicinal agent c) ≤ 90 days: i) Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first trial vaccine administration or planned administration during the trial period. (For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent). Inhaled, topical, and intraarticular steroids are allowed.
• If female is pregnant (known before or established at the time of screening), breastfeeding, or planning breastfeeding or a pregnancy
• Is undergoing chemotherapy or expected to receive chemotherapy during the trial period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
• Oral temperature ≥ 38°C (≥ 100.4°F) at the time of vaccine administration
• History of acute myocardial infarction (AMI) or documented coronary artery disease (CAD)

Sponsors & Collaborators

• Dynavax Technologies Corporation: lead
• United States Department of Defense: collaborator

Study Sites (3)

AMR- Miami

Miami, Florida, 33134, United States

NOT YET RECRUITING

AMR- El Dorado

El Dorado, Kansas, 67042, United States

RECRUITING

AMR- Las Vegas

Las Vegas, Nevada, 889119, United States

RECRUITING

Central Study Contacts

Ouzama Henry, MD, Vice President, Clinical Development

CONTACT

510-848-5100; ohenry@dynavax.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is partially blinded which means observers and participants know what study vaccine is being administered for some treatment arms but not for other treatment arms.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 6, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)