Evaluation of Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine in Adults With Good General Health

Inclusion Criteria

• •Inclusion:
• •Good general health
• •≥18 years of age on the day of screening and are ≤50 years of age on the day of IP administration
• •Adherence to the requirements of the protocol and the follow-up for the planned duration of the study
• •Undergo HIV testing, risk reduction counseling, and receive HIV test results
• •As applicable use male or female condoms for 1 month following IP administration
• •Use an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccine
• •As applicable undergo urine pregnancy tests
• •Forgo donation of blood or any other tissues throughout the course of the study
• •Exclusion:
• •Any clinically relevant abnormality
• •Any clinically significant acute or chronical medical condition
• •Women who are pregnant or breastfeeding
• •Bleeding disorder
• •Infectious disease
• •History of splenectomy
• •Receipt of any vaccine within the previous 28 days or planned receipt within 28 days after vaccination with IP.
• •Receipt of blood transfusion or blood-derived products within 3 months prior to screening
• •Prior exposure to SEBOV or history of any hemorrhagic fever
• •Prior receipt of any VSV-vectored vaccine
• •Receipt of another IP within 3 months prior to enrollment or expected participation during this study.
• •Prior receipt of another Sudan Ebola vaccine or receipt of polyclonal or monoclonal antibodies directed against Sudan Ebola in the past 6 months
• •History of severe reactogenicity to vaccines or severe allergy to food or medications
• •A history of malignancy in the past 5 years (prior to screening) or ongoing malignancy.
• •Serious infections requiring antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment
• •Body mass index (BMI) ≥35
• •Current or planned occupational or household contact from screening through 3 months after vaccine administration with any immunocompromised individual