Phase
Condition
N/ATreatment
rF1V-1018
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults 18 to 55 years of age
Healthy participants or participants with stable pre-existing medical conditionsPre-existing stable medical condition means a participant who: has full capacity ofdaily activity and no major medication modification within 3 months prior to Day 1;has not undergone surgical or minimally-invasive intervention or had anyhospitalization/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 practicedadequate contraception for at least 28 days prior to vaccination, has negativepregnancy tests just prior to vaccination, and has agreed to continue adequatecontraception 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
Exclusion
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 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 vaccinescontaining mRNA or CpG) b) ≤ 28 days: i) Any live vaccine ii) Any investigationalmedicinal agent c) ≤ 90 days: i) Chronic administration (defined as more than 14consecutive days in total) of immunosuppressants or other immune-modifying drugsduring the period starting 90 days prior to the first trial vaccine administrationor planned administration during the trial period. (For corticosteroids, this willmean prednisone ≥20 mg/day, or equivalent). Inhaled, topical, and intraarticularsteroids are allowed. ii) Granulocyte or granulocyte-macrophage colony stimulating factor iii)Immunoglobulins or any blood products (receipt of certain monoclonal antibodies mayon a case-by-case basis be non-exclusionary if approved via consultation withSponsor Medical Monitor) iv) Antisense oligonucleotides v) Drugs/investigationalagents with very long half-lives (defined as ≥ 60 days) (eg, radioactive iodine,amiodarone, liraglutide, nirsevimab, teplizumab, evinacumab, and obinutuzumab) vi)Infusion of blood products d) At any time: DNA plasmids or other genetic therapyintended to integrate permanently into host cells
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 trialperiod; has a diagnosis of cancer within the last 5 years other than squamous cellor basal cell carcinoma of the skin
History or current evidence of any condition, therapy, or laboratory abnormalitythat might confound the results of the trial, interfere with participation for thefull duration of the trial, or is not in the best interest of the participant toparticipate, 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)
Study Design
Study Description
Connect with a study center
103
Miami, Florida 33172
United StatesSite Not Available
AMR- El Dorado
El Dorado, Kansas 67042
United StatesSite Not Available
AMR- Las Vegas
Las Vegas, Nevada 889119
United StatesSite Not Available
CTI Clinical Research Center
Cincinnati, Ohio 45212
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.