A Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Sudan Ebolavirus Vaccine in Healthy Adults

Inclusion Criteria:

1. Able and willing to complete and provide informed consent prior to any trialprocedure including optional consent for retention of blood samples for potentialfuture testing and assay development. As part of the informed consent process, theparticipant must complete a Test of Understanding (ToU) about the study and answerat least 90% of the questions correctly at least once in three attempts;

2. Male or non-pregnant female 18 to 70 (inclusive) years of age at time of consent;

3. Is capable of understanding and agrees to comply with planned trial procedures andto be available for all clinic follow-up for all planned trial visits;

4. Able to provide proof of identity to the satisfaction of the trial cliniciancompleting the enrollment process; has a means to be contacted and to contact theinvestigator during the trial;

5. Agree not to receive any vaccine within 3 months of trial vaccination (prior andafter) trial;

6. Agree not to donate bone marrow, blood, or blood products until 3 months after thetrial vaccination;

7. In good general health without clinically significant medical conditions, based onmedical history, physical examination, vital signs, and clinical laboratory resultsas deemed acceptable by PI;

8. Clinical laboratory results within 28 days prior to vaccination within the testinglaboratory reference ranges (or deemed not clinically significant by the PI) for thefollowing parameters: White blood cells (WBC), Complete blood count (CBC), Red bloodcells (RBC), Hemoglobin (HGB), total lymphocyte count, coagulation tests to includeprothrombin time in terms of INR, fibrinogen, protein C, d-dimer, and chemistrytests to include alanine aminotransferase (ALT), aspartate aminotransferase (AST),and serum creatinine. A laboratory result that is outside the reference range and isdeemed not clinically significant by the PI will not exclude the participant;

9. Has a body mass index (BMI) >17 and ≤ 37 at screening. Female participant specific criteria:

10. Negative pregnancy serum test at screening, and negative urine pregnancy test beforevaccination AND:

11. Use of oral, implantable, transdermal or injectable contraceptives for 21 days priorto vaccination and for at least 24 weeks after vaccination, UNLESS the participantfulfills one of the following criteria:

12. At least 1 year post-menopausal.

13. Surgically sterile.

14. Use of another reliable form of contraception must be approved by theInvestigator (e.g., double barrier method, intrauterine device, contraceptivepatches). Male participants must agree:

15. Not to father a child or donate sperm for at least 24 weeks after vaccination;

16. To use an effective means of birth control from at least 21 days prior tovaccination and for at least 24 weeks after vaccination if assessed to be ofreproductive potential.

Exclusion Criteria:

1. Participant is female and is breastfeeding or plans to become pregnant or breastfeedfrom trial vaccination through 24 weeks post-vaccination

2. Has any medical disease or condition that, in the opinion of the investigator,precludes trial participation. This includes any acute, subacute, intermittent, orchronic medical disease or condition that would place the Participant at anunacceptable risk of injury, render the Participant unable to meet the requirementsof the protocol, or may interfere with the evaluation of responses or theParticipant's successful completion of the trial; (Chronic conditions that arewell-controlled and medically stable, i.e. no relevant change in treatment formedical reasons occurred in the last 6 months, are allowed at the discretion of thePI, e.g. hypertension, asthma, thyroid disease) Any confirmed or suspectedimmunosuppressive or immunodeficient condition resulting from disease (e.g.,malignancy, Human Immunodeficiency Virus [HIV] infection) orimmunosuppressive/cytotoxic therapy (e.g., medications used during cancerchemotherapy, organ transplantation or to treat autoimmune disorders) and anyinfection requiring IV antibiotics or hospitalization within 90 days prior toscreening.

3. History of Guillain-Barré syndrome

4. History of allergy to any component of the vaccine

5. Serology screen positive for infectious diseases (hepatitis B, hepatitis C, HIV,Human T-cell leukemia virus (HTLV), Syphilis);

6. Known prior exposure to Sudan Ebolavirus or prior diagnosis of Sudan EbolavirusDisease, determined from the participant's reported medical history

7. History of or active status of any of the following clinically significantconditions:

8. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives),respiratory difficulty, angioedema, or abdominal pain;

9. Allergic reaction to excipients in the trial vaccine including gentamycin,neomycin or streptomycin;

10. Diabetes mellitus Type I or Type II (even if stable)

11. Tuberculosis

12. Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms ofangioedema;

13. Idiopathic urticaria within the last year

14. Any malignancy, including non-skin melanoma, that has been active or treated,within 5 years prior to screening. (If diagnosed malignancy is 5 or more yearsprior to enrollment and cured with no ongoing treatment it will NOT beconsidered an exclusion);

15. Seizure in the past 3 years or treatment for seizure disorder in the past 3years (even if stable);

16. Asplenia or functional asplenia;

17. Any medical, psychiatric, social condition, occupational reason or otherresponsibility that, in the judgment of the investigator, is a contraindicationto protocol participation or impairs a participant's ability to give informedconsent;

18. Hematologic History:

19. Bleeding disorder diagnosed by a doctor or use of anticoagulant medicationssuch as, Warfarin, Apixaban, Dabigatran (e.g. factor deficiency, coagulopathy,or platelet disorder requiring special precautions) or significant bruising orbleeding difficulties with IM injections or blood draws;

20. Family and personal history of bleeding or thrombosis or heparin-inducedthrombocytopenia

21. Conditions known to increase risk of thrombosis (e.g., pregnant or post-partum,extreme obesity, active malignancy or post-transplantation, recent surgery,immobility, recent infection, recent head trauma, autoimmune disease,inflammatory disease),

22. Receipt of blood products within 3 months prior to enrollment.

23. Has donated ≥ 450 mL of blood products within 30 days prior to randomization orexpects to donate blood within 90 days of vaccine administration

24. History of heparin-related thrombotic events, and/or receiving heparintreatments

25. Has a clinically significant acute illness (this does not include minor illnessessuch as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0°Celsius (≥100.4° Fahrenheit) within 24 hours of the planned dose of trial vaccine,rescreening and randomization at a later date is permitted at the discretion of theinvestigator and after consultation with the sponsor

26. Receipt of any of the following substances:

27. prior receipt of Sudan Virus Vaccine or Marburg Virus Vaccine

28. prior receipt of any adenoviral vectored vaccine, adenovirus-based oradeno-associated virus (AAV)-based gene therapies or treatments, includingadenoviral COVID-19 vaccines or boosters.

29. Participant received an investigational drug (including investigational drugsfor prophylaxis of COVID-19) within within 3 months of dosing, or has used aninvasive investigational medical device within 3 months of dosing

30. received immunoglobulin (Ig) or monoclonal antibodies within 3 months,

31. is currently enrolled or plans to participate in another investigational orinterventional trial during the course of this trial (observational/registrytrials are allowed)

32. Use of systemic corticosteroids in daily dose equivalence > 20 mg of prednisolone inthe last 90 days, and for periods exceeding 10 days. Non-steroidal anti-inflammatorydrugs [NSAIDS] are permitted.

33. Current anti-tuberculosis prophylaxis or therapy