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

A Phase 1, Single-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine at 3 Dose Levels in Adults in Good General Health

Inclusion:Good general health≥18 years of age on the day of screening and are ≤50 years of age on the day of IP administrationAdherence to the requirements of the protocol and the follow-up for the planned duration of the studyUndergo HIV testing, risk reduction counseling, and receive HIV test resultsAs applicable use male or female condoms for 1 month following IP administrationUse an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccineAs applicable undergo urine pregnancy testsForgo donation of blood or any other tissues throughout the course of the studyExclusion:Any clinically relevant abnormalityAny clinically significant acute or chronical medical conditionWomen who are pregnant or breastfeedingBleeding disorderInfectious diseaseHistory of splenectomyReceipt 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 screeningPrior exposure to SEBOV or history of any hemorrhagic feverPrior receipt of any VSV-vectored vaccineReceipt 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 monthsHistory of severe reactogenicity to vaccines or severe allergy to food or medicationsA 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 enrollmentBody mass index (BMI) ≥35Current or planned occupational or household contact from screening through 3 months after vaccine administration with any immunocompromised individual