Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults

Inclusion Criteria:

1. Able and willing to complete and provide written informed consent prior to any studyprocedure; including injection site photograph consent, completing an Assessment ofUnderstanding (AoU) prior to enrollment by answering 9 out of 10 questions correctlyat least once in 3 attempts, and including optional consent for retention of bloodsamples for potential future testing and assay development. Note: Participants canbe enrolled even if they do not provide optional consent for retention of bloodsamples for potential future testing and assay development.

2. Able to read and write the language used in diary card.

3. Male or non-pregnant female 18 to 70 years of age (inclusive) at time of informedconsent.

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

5. Able to provide proof of identity to the satisfaction of the study cliniciancompleting the enrollment process.

6. Has a means to be contacted and to contact the investigator during the study.

7. Agree not to receive any vaccine within 28 days from study vaccination (prior andafter), with the exception of an emergency use authorization or authorizednon-adenoviral vectored COVID-19 vaccine, which may be given within 14 days of studyvaccination.

8. Agree not to donate bone marrow, blood, or blood products until 3 months after thestudy vaccination.

9. In good general health without clinically significant medical conditions, based onmedical history, physical examination, vital signs, and clinical laboratory resultsas deemed acceptable by the principal investigator.

10. Clinical laboratory results within 28 days prior to vaccination within the site'slaboratory reference ranges (or deemed not clinically significant by the principalinvestigator) for the following parameters: hematology (CBC including hemoglobin,WBC, RBC, total lymphocyte count); coagulation tests (prothrombin time, INR,fibrinogen); chemistry (C-reactive protein, d-dimer, ALT, AST, and serumcreatinine). A laboratory result that is outside the reference range and is deemednot clinically significant by the principal investigator will not exclude theparticipant.

11. Has a BMI >17 and ≤37 at screening. Female participant-specific criteria:

12. Negative pregnancy serum test at screening, and negative urine pregnancy test beforevaccination, if of reproductive potential.

13. Agrees to use an effective means of birth control from at least 21 days prior toenrollment through 24 weeks after study vaccination if assessed to be woman ofchildbearing potential UNLESS they fulfill one of the following criteria:

• At least 1 year postmenopausal.

• Surgically sterile. Male participants must agree:

14. Not to father a child or donate sperm through study end.

15. To use a barrier (condom) means of birth control from vaccination through study end,if assessed to be of reproductive potential.

Exclusion Criteria:

1. Pregnant or lactating female or plans to become pregnant or breastfeed starting fromstudy vaccination through to study end.

2. Has any medical disease or condition that, in the opinion of the investigator,precludes study participation. This includes any acute, subacute, intermittent, orchronic medical disease or condition that:

• would place the participant at an unacceptable risk of injury,

• render the participant unable to comply with the requirements of the protocol,

• or may interfere with the evaluation of responses or the participant'ssuccessful completion of the trial (chronic conditions that are well-controlledand medically stable, i.e., no change in treatment for medical reasons occurredin the last 6 months and are allowed at the discretion of the principalinvestigator, e.g., hypertension, asthma, thyroid disease). The medical diseaseor condition also includes any confirmed or suspected immunosuppressive orimmunodeficient conditions resulting from disease (e.g., malignancy, HIVinfection) or immunosuppressive/cytotoxic therapies (e.g., medications usedduring cancer chemotherapy, organ transplantation or to treat autoimmunedisorders).

3. Serology screen positive for infectious diseases (hepatitis B, hepatitis C, HIV 1and 2, syphilis).

4. Known history of prior exposure to SUDV or prior diagnosis of SUVD.

5. Current diagnosis of COVID-19 by Reverse Transcription Polymerase Chain Reaction (RT-PCR) or antigenic testing or current signs and symptoms of COVID-19.Participants may be enrolled 14 days post resolution of all signs and symptoms ofCOVID-19 or of testing positive for COVID-19 in asymptomatic participants.

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

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

• Allergic reaction to excipients in the study vaccine including gentamycin,neomycin or streptomycin or any other aminoglycoside.

• Diabetes mellitus type 1 or type 2.

• Active tuberculosis.

• Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.

• Idiopathic urticaria within the last year.

• Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy,or platelet disorder requiring special precautions), use of anticoagulantmedications such as warfarin, apixaban, or dabigatran, or significant bruisingor bleeding difficulties with IM injections or blood draws.

• Major thrombotic event or heparin-induced thrombocytopenia or Vaccine-InducedThrombotic Thrombocytopenia (VITT).

• Malignancy of any organ system, treated or untreated, within the past 5 yearsfrom screening (if diagnosed malignancy is 5 or more years prior to enrollmentand cured with no ongoing treatment it will NOT be considered an exclusion).

• Seizure in the past 3 years or treatment for seizure disorder in the past 3years.

• Asplenia or functional asplenia.

• Autoimmune disease/autoinflammatory condition.

• 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.

7. Has a clinically significant acute illness (this does not include minor illnesses)or temperature ≥38.0°Celsius (≥100.4° Fahrenheit) within 24 hours of the planneddose of study vaccine. Re-evaluation of eligibility may be performed at resolutionof all signs and symptoms, and randomization at a later date is permitted at thediscretion of the investigator and after consultation with the sponsor (asappropriate).

8. Receipt of any of the following substances:

• COVID-19 vaccine that has not received emergency use authorization or approvalper local regulatory agency.

• Prior receipt of Ebola or Marburg vaccine.

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

• Participant received an investigational drug (including investigational drugsfor prophylaxis of COVID-19) within 28 days of dosing or within washout period (5 half-lives) of such drug or has used an invasive investigational medicaldevice within 28 days of dosing.

• Received investigational Ig or monoclonal antibodies within 3 months.

• Received convalescent serum for COVID-19 treatment within 3 months.

• Received an investigational vaccine within 3 months before the plannedadministration of the first dose of study vaccine.

• Is currently enrolled or plans to participate in another investigational orinterventional study during this study (observational/registry studies areallowed).

9. Use of immunomodulators or systemic glucocorticoids in daily doses of glucocorticoidequivalence >20 mg of prednisolone in the last 90 days, and for periods exceeding 10days. Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) are permitted.

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

11. Current anti-tuberculosis prophylaxis or therapy.

12. Abnormality or permanent body art (such as tattoo) in deltoid region that wouldinterfere with ability to observe or assess injection site reactions.