| Each participant must meet all of the following criteria to be enrolled in this study:
1. Male and non-pregnant female participants ≥18 years who are able and willing to complete and provide written informed consent prior to any study procedure.
Note: Participants can be enrolled even if they do not provide optional consent for retention of blood samples for potential future testing and assay development.
2. Is capable of understanding and agrees to comply with planned study procedures and to be available for all clinic follow-up for all planned study visits.
3. Able to provide proof of identity to the satisfaction of the study clinician, completing the enrollment process.
4. Has a means to be contacted and to contact the investigator during the study.
5. Agree not to receive any vaccine within 28 days from study vaccination (prior and after)
6. Agree not to donate bone marrow, blood, or blood products until 3 months after the study vaccination.
7. In good general health without clinically significant medical conditions, based on medical history, physical examination, vital signs, and clinical laboratory results as deemed acceptable by the principal investigator.
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Participants meeting any of the following criteria will be excluded from the study:
1. Pregnant or lactating female or plans to become pregnant or breastfeed
2. Has any medical disease or condition that, in the opinion of the investigator, precludes study participation.
3. Known prior diagnosis of MVD, including active Marburg infection, determined from the participant’s reported medical history.
4. History of or active status of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines
• Allergic reaction to excipients in the IP
• History of Diabetes mellitus Type I or Type II
• Active Tuberculosis.
• Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
• Idiopathic urticaria within the last year
• Bleeding disorder diagnosed by a doctor or use of anticoagulant medications
• Major thrombotic event or heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia (VITT)
• History of malignancy of any organ system, treated or untreated, within the past 5 years from screening.
5. Has a clinically significant acute illness (this does not include minor illnesses) or temperature ≥38.0°Celsius (≥100.4°Fahrenheit) within 24 hours of the planned dose of IP
6. Receipt of any of the following substances:
• Received an investigational vaccine or drug 28 days before, during and after the planned administration of the first dose of IP.
• Receipt of remdesivir within 6 days prior to receipt of IP
• Use of immunomodulators or systemic glucocorticoids in daily doses of glucocorticoid equivalence >20 mg of prednisolone in the last 90 days, and for periods exceeding 10 days. Nonsteroidal anti-inflammatory drugs are permitted.
• Receipt of blood products within 3 months prior to enrollment.
7. Current anti-tuberculosis prophylaxis or therapy.
8. Abnormality or permanent body art in deltoid region that would interfere with ability to observe or assess injection site reactions.
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80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
100 Year(s) |
Both |