A Phase 1 Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health

Exclusion Criteria18

• Any clinically relevant abnormality on history or examination including:
• history of immunodeficiency or autoimmune disease history of splenectomy history of malignancy in the past 5 years use of corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the Investigator within the previous 6 months body mass index (BMI) ≥ 35.0 kg/m2
• Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study
• Individuals who are pregnant or breastfeeding
• Bleeding disorder that was diagnosed by a physician
• Infectious disease: Confirmed HIV-1 or HIV-2 infection, chronic active hepatitis B infection, current hepatitis C infection, active syphilis, or medically diagnosed long COVID 19 Syndrome. Also excluded are participants with active, serious infections requiring parenteral antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment.
• Any abnormal laboratory parameters at screening per protocol.
• Receipt of live attenuated influenza vaccine within the previous 14 days, any other live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with IP; or receipt of non-live attenuated vaccine within the previous 14 days or planned receipt within 14 days after vaccination with IP, including COVID-19 vaccines
• Receipt of blood transfusion or blood-derived products within the previous 3 months
• Prior potential exposure to Marburg Virus, or a medical history of hemorrhagic fever
• Prior receipt of any VSV-vectored vaccine, any Marburg vaccine, or any vaccine containing a filovirus component. Prior receipt of monoclonal or polyclonal antibodies directed against Marburg or other filovirus in the past 12 months
• Current participation in another clinical trial, within 3 months prior to enrollment.
• History of severe local or systemic reactogenicity to vaccines, or severe allergy to food or medications, and/or allergy to any component of this vaccine.
• Neuropsychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol
• Current or planned occupational (medical care, childcare) or household contact (residing in the same household) from screening through 3 months after IP administration with any individual at increased risk from exposure to a live viral vaccine including infants ≤ 1 year of age, adults ≥75 years of age, or immunocompromised individuals.
• In the opinion of the PI, it is not in the best interest of the participant to participate in the trial
• A history of long-term treatment (≥ 4 weeks) for arthritis
• Participants currently experiencing a rash or who have a history of severe, chronic, or frequent rash will be excluded.