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
Plague, Pneumonic, Plague, Vaccine-Preventable Diseases
About this trial
This is an interventional prevention trial for Plague, Pneumonic
Eligibility Criteria
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
- 28 days:
- Any other vaccine
- Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immunomodulators immune suppressive medication, with the exception of inhaled steroids
- Granulocyte or granulocyte-macrophage colony-stimulating factor
- Any other investigational medicinal agent
- 90 days: immunoglobulins or any blood products
- At any time: an injection of deoxyribonucleic acid (DNA) plasmids or oligonucleotides
- 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)
Sites / Locations
- Optimal Research Alabama
- Optimal Research California
- Optimal Research Florida
- Optimal Research Illinois
- Optimal Research Maryland
- Optimal Research Texas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Experimental
Part 1 Group 1:rF1V vaccine and CpG 1018® adjuvant co-administered
Part 1 Group 2:rF1V vaccine and CpG 1018® adjuvant bedside mix
Part 1 Group 3: rF1V vaccine and placebo
Part 2 Group 1 & 3, OR Group 2 & 3
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
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
rF1V vaccine and placebo will be administered on Days 1, 29, and 183
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