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Tests treatment safety and results for Prevention of Pneumonic Plague Resulting From Aerosol...
Official title Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age
ClinicalTrials.gov ID: NCT07207408
What this study is testing
What is rF1V-1018?
rF1V-1018 is an investigational medicine, being studied as a potential treatment for prevention of pneumonic plague resulting from aerosol exposure to yersinia pestis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Adults 18 to 55 years of age
- Healthy participants or participants with stable pre-existing medical conditions Pre-existing stable medical condition means a participant who: has...
- 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 at least 28 days prior to vaccination, has...
You likely can't join if
- 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
See the full eligibility criteria
- Adults 18 to 55 years of age
- Healthy participants or participants with stable pre-existing medical conditions Pre-existing stable medical condition means a participant who: has full capacity of daily activity and no major medication modification...
- 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 at least 28 days prior to vaccination, has negative pregnancy tests just prior to vaccination, and has agreed to...
- Documented hysterectomy
- Documented bilateral salpingectomy
- Documented bilateral oophorectomy
- Documented and current bilateral tubal ligation or occlusion
- 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...
- 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...
- 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) \-
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- El Dorado, Kansas, United States
- Las Vegas, Nevada, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; El Dorado, Kansas, United States; Las Vegas, Nevada, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.