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

About this trial
This is an interventional prevention trial for Ebola Sudan Virus Disease
Eligibility 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
Sites / Locations
- Benchmark Research
- Clinical Trials of Texas
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Study Group 1
Study Group 2
Study Group 3
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^6 pfu intramuscularly Day 1
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^7 pfu intramuscularly Day 1
rVSV∆G-SEBOV-GP Vaccine or Placebo Dosage 2 × 10^8 pfu intramuscularly Day 1