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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Vaccine-Preventable Diseases; Plague; Plague, Pneumonic
• Intervention / Treatment: Biological: rF1V vaccine and CpG 1018® adjuvant; Biological: rF1V vaccine

Detailed Description

Phase 2, randomized, active-controlled, observer-blind, multicenter trial of the immunogenicity, safety, and tolerability of rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine alone in adults. Approximately two hundred healthy adults 18 to 55 years of age will be enrolled to compare a two-dose regimen of rF1V vaccine with CpG 1018® adjuvant administered on study Days 1 and 29 (and placebo at Day 183) with a three-dose regimen of rF1V vaccine alone administered on study Days 1, 29, and 183. The study will be conducted in 2 parts (Part 1 and Part 2).

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802-2569
      • Optimal Research Alabama
  • California
    • San Diego, California, United States, 92108
      • Optimal Research California
  • Florida
    • Melbourne, Florida, United States, 32934-8172
      • Optimal Research Florida
  • Illinois
    • Peoria, Illinois, United States, 61614-4885
      • Optimal Research Illinois
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Optimal Research Maryland
  • Texas
    • Austin, Texas, United States, 78705-2655
      • Optimal Research Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:
• 14 days:
• COVID-19 vaccine
• Any inactivated vaccine
• 28 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
• 90 days:
• Immunoglobulins or any blood products
• Granulocyte or granulocyte-macrophage colony-stimulating factor
• Antisense oligonucleotides
• Drugs/investigational agents with very long half-lives (defined as ≥ 60 days)
• At any time: DNA plasmids or other genetic therapy intended to integrate permanently into host cells
• If female is pregnant (known before or established at the time of screening), breastfeeding, or planning a pregnancy
• Is undergoing chemotherapy or expected to receive chemotherapy during the study 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 study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• Oral temperature >100.0°F at the time of vaccine administration.
• History of acute myocardial infarction (AMI) or documented coronary artery disease (CAD)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Group 1:rF1V vaccine and CpG 1018® adjuvant co-administered; rF1V vaccine and CpG 1018® adjuvant will be administered on Days 1 and 29, and 2 injections of placebo will be administered on Day 183	Biological: rF1V vaccine and CpG 1018® adjuvant; rF1V vaccine and CpG 1018® adjuvant
Experimental: Part 1 Group 2:rF1V vaccine and CpG 1018® adjuvant bedside mix; Bedside mix of rF1V vaccine and CpG 1018® adjuvant and placebo will be administered on Days 1 and 29, and 2 injections of placebo will be administered on Day 183	Biological: rF1V vaccine and CpG 1018® adjuvant; rF1V vaccine and CpG 1018® adjuvant
Active Comparator: Part 1 Group 3: rF1V vaccine and placebo; rF1V vaccine and placebo will be administered on Days 1, 29, and 183	Biological: rF1V vaccine; rF1V vaccine
Experimental: Part 2 Group 1 & 3, OR Group 2 & 3; Group 1 & 3 (if selected): Group 1: rF1V vaccine and CpG 1018® adjuvant will be administered on Days 1 and 29, and 2 injections of placebo will be administered on Day 183. Group 3: rF1V vaccine and placebo will be administered on Days 1, 29, and 183 OR Group 2 & 3 (if selected): Group 2: Bedside mix of rF1V vaccine and CpG 1018® adjuvant will be administered on Days 1 and 29; placebo will be administered on Day 183. Group 3: rF1V vaccine will be administered on Days 1, 29, and 183	Biological: rF1V vaccine and CpG 1018® adjuvant; rF1V vaccine and CpG 1018® adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Select one method of administration of rF1V vaccine with CpG 1018® adjuvant for Part 2	To select one of the two methods of administration of rF1V vaccine with CpG 1018® adjuvant for Part 2 by comparing humoral immunization response 28 days after the second dose of vaccine	28 days after second dose of vaccine of last participant in part 1
Assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant	To assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant as measured by reduction in time to onset of predicted rF1V protection	Through day 211 in part 2
Assess the serum Bridge ELISA concentration to rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine 28 days after the second dose of vaccine		28 days after second dose of vaccine of last participant in part 2

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the serum Bridge ELISA concentration to rF1V vaccine with CpG 1018® adjuvant at selected time points after each dose	Week 0, 4, 8, 12, 16, 30, 38, 50
To assess the safety and tolerability of rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine as measured by rates of reactogenicity and adverse events using grading system in CBER's toxicity guidance document.	Through week 50

Other Outcome Measures

Outcome Measure	Time Frame
To assess long term clinical benefit from rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine	Through week 30
To assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant as measured by reduction in time to onset of predicted rF1V protection using peak serum Bridge ELISA concentration	Through week 30
To assess the peak serum bridge ELISA concentration from rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine 28 days after the complete series	Through week 50
To assess the serum Bridge ELISA concentration to rF1 and rV with CpG1018® adjuvant at selected time points after each dose	Through Week 50

Collaborators and Investigators

• Sponsor: Dynavax Technologies Corporation
• Collaborators: United States Department of Defense
• Investigators: Study Chair: Robert Janssen, MD, Dynavax Technologies Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): October 3, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Yersinia Infections; Vaccine-Preventable Diseases; Plague; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Vaccines; 1018 oligonucleotide
• Other Study ID Numbers: DV2-PLG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No