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About
This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine
Full description
This dose-finding study will evaluate the immunogenicity, safety, and tolerability of multiple doses and regimens of rF1V-1018 vaccine in healthy adults. Immunogenicity blood samples will be drawn at several timepoints during the study. Participants will return to the clinic for periodic visits for study specific evaluations including evaluation of immunogenicity and safety. Safety assessments will be done at regular intervals through the end of the trial.
Six dose regimens will be tested in Part 1 of the study. Up to two dose regimens from Part 1 will be chosen for Part 2 of the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
A premenopausal woman who has at least one of the following is considered not of childbearing potential:
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 vaccines containing mRNA or CpG) b) ≤ 28 days: i) Any live vaccine ii) Any investigational medicinal agent c) ≤ 90 days: i) Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first trial vaccine administration or planned administration during the trial period. (For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent). Inhaled, topical, and intraarticular steroids are allowed.
ii) Granulocyte or granulocyte-macrophage colony stimulating factor iii) Immunoglobulins or any blood products (receipt of certain monoclonal antibodies may on a case-by-case basis be non-exclusionary if approved via consultation with Sponsor Medical Monitor) iv) Antisense oligonucleotides v) Drugs/investigational agents 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 therapy intended 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 trial 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 trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant to participate, 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)
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Primary purpose
Allocation
Interventional model
Masking
148 participants in 6 patient groups
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Central trial contact
Ouzama Henry, MD, Vice President, Clinical Development
Data sourced from clinicaltrials.gov
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