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

Completed

Conditions: Plague
Vaccine-Preventable Diseases
Plague, Pneumonic

Interventions: Biological: rF1V-1018
Biological: rF1V vaccine

Registration Number: NCT05506969

Lead Sponsor: Dynavax Technologies Corporation

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

Detailed Description: Phase 2, randomized, active-controlled, observer-blind, multicenter trial of the immunogenicity, safety, and tolerability of rF1V vaccine with CpG 1018® adjuvant (rF1V-1018) 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-1018 with a three-dose regimen of rF1V vaccine alone. The study will be conducted in 2 parts (Part 1 and Part 2).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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 & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
rF1V-1018 co-administered (rF1V vaccine and CpG 1018® adjuvant co-administered)	rF1V-1018	Co-administration of rF1V vaccine and CpG 1018® adjuvant administered as 2 injections
rF1V-bedside mix (rF1V vaccine and CpG 1018® adjuvant bedside mix)	rF1V-1018	Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered administered as 2 injections
rF1V vaccine only	rF1V vaccine	rF1V vaccine administered as 3 injections

Primary Outcome Measures

Name	Time	Method
Rates of Reactogenicity and Safety	Day 1 to Week 56	Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (6): Optimal Research Alabama
🇺🇸
Huntsville, Alabama, United States
Optimal Research California
🇺🇸
San Diego, California, United States
Optimal Research Florida
🇺🇸
Melbourne, Florida, United States
Optimal Research Illinois
🇺🇸
Peoria, Illinois, United States
Optimal Research Maryland
🇺🇸
Rockville, Maryland, United States
Optimal Research Texas
🇺🇸
Austin, Texas, United States
Optimal Research Alabama
🇺🇸Huntsville, Alabama, United States