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 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: DV2-PLG-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rates of Reactogenicity and Safety

  Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths

  Day 1 to Week 56

Study Arms (3)

rF1V-1018 co-administered (rF1V vaccine and CpG 1018® adjuvant co-administered)

EXPERIMENTAL

Co-administration of rF1V vaccine and CpG 1018® adjuvant administered as 2 injections

Biological: rF1V-1018

rF1V-bedside mix (rF1V vaccine and CpG 1018® adjuvant bedside mix)

EXPERIMENTAL

Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered administered as 2 injections

Biological: rF1V-1018

rF1V vaccine only

EXPERIMENTAL

rF1V vaccine administered as 3 injections

Biological: rF1V vaccine

Interventions

rF1V-1018 BIOLOGICAL

rF1V vaccine and CpG 1018® adjuvant

rF1V-1018 co-administered (rF1V vaccine and CpG 1018® adjuvant co-administered); rF1V-bedside mix (rF1V vaccine and CpG 1018® adjuvant bedside mix)

rF1V vaccine BIOLOGICAL

rF1V vaccine

rF1V vaccine only

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 55 years
• Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
• Pre-existing stable medical condition means a subject 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 28 days prior to vaccination and has negative pregnancy tests just prior to vaccination and has agreed to continue adequate contraception until 28 days after last study injection. Adequate contraception is defined as a contraceptive method with a failure rate of \< 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. Examples include the following:
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
• Progestin-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
• Intrauterine device (IUD) with or without hormonal release
• Vasectomized partner, provided he is the subject's sole partner and that he has received a medical assessment of the surgical success
• Credible self-reported history of heterosexual abstinence for at least 28 days prior to vaccine administration
• Female partner

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 study vaccines
• Body mass index ≥ 30 kg/m2
• Has received the following prior to the injection:
• days:
• COVID-19 vaccine
• Any inactivated vaccine
• days:
• Any live vaccine
• Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immunomodulators immune suppressive medication, with the exception of inhaled steroids
• Any other investigational medicinal agent
• days:

Sponsors & Collaborators

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

Study Sites (6)

Optimal Research Alabama

Huntsville, Alabama, 35802-2569, United States

Location

Optimal Research California

San Diego, California, 92108, United States

Location

Optimal Research Florida

Melbourne, Florida, 32934-8172, United States

Location

Optimal Research Illinois

Peoria, Illinois, 61614-4885, United States

Location

Optimal Research Maryland

Rockville, Maryland, 20850, United States

Location

Optimal Research Texas

Austin, Texas, 78705-2655, United States

Location

MeSH Terms

Conditions

Plague; Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Yersinia Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases

Results Point of Contact

• Title: Ouzama Henry, MD
• Organization: Dynavax Technologies

ohenry@dynavax.com

617-686-4796

Study Officials

• Robert Janssen, MD

  Dynavax Technologies Corporation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 18, 2022
• Study Start: August 9, 2022
• Primary Completion: October 3, 2023
• Study Completion: April 26, 2024
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)