Safety, Tolerability and Immunogenicity of Alveavax-v1.2, a BA.2/Omicron-optimized, DNA Vaccine for COVID-19 Prevention

Inclusion Criteria:

1. Healthy adult male and female volunteers between 18 and 65 years of age, inclusive.
2. Participants who received a primary Janssen Ad26.CoV2.S vaccine ≥ 60 days prior toreceiving the study vaccine.
3. Body mass index within the range 18 - 32 kg/m2 both inclusive.
4. Participants who, judged by the Investigator, are in stable health as determined bytheir pre-study medical history, physical examination, and clinical laboratory tests.
5. Female participants must be either of non-childbearing potential, i.e., surgicallysterilized (defined as having undergone hysterectomy and/or bilateral oophorectomyand/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) orone year postmenopausal; or, if of childbearing potential, they must be abstinent orhave used adequate contraceptive precautions for 30 days prior to receiving the studyvaccination and 84 days post-vaccine.
6. Sexually active male participants who are considered sexually fertile must agree touse a barrier method of contraception during sexual activity with a female ofchildbearing potential from the time of vaccination until at least 84 days after thevaccination.
7. Participants must provide written informed consent or their legal representative mustunderstand and give written consent to the procedure.
8. Participants must be willing and able to comply with all the required study visits andfollow-up required by this protocol, and be able to complete the diary card aftervaccination or have a caregiver available to assist with these matters.

Exclusion Criteria:

1. Received any other SARS-CoV-2 vaccination than a single Janssen Ad26.COV2.S vaccine orplans to receive any additional SARS-CoV-2 vaccination within 90 days after the studyvaccine (Day 1).
2. Recovered from SARS-CoV-2 infection determined by history of a positive SARS-CoV-2test (e.g. PCR, rapid antigen test, etc.) or suspicion of a SARS-CoV-2 infection basedon the (verbal) medical history within less than 60 days from the day of vaccination (Day 1) in this study.
3. History of close contact (face-to-face contact within 1 meter or contact in a closedspace for more than 15 minutes) without wearing a face-mask with a confirmed activeSARS-CoV-2-positive patient within 5 days prior to Day 1.
4. Have received any live-virus vaccine within 4 weeks or inactivated vaccine, includinginfluenza vaccine, within 2 weeks (both licensed and investigational vaccines) priorto the study vaccine (Day 1).
5. Previous participation in any clinical trial of a SARS-CoV-2 vaccine candidate.
6. Have any febrile illness (temperature ≥ 38°C/100.4°F) or any active acute illness orinfection (including a positive SARS-CoV-2 PCR test) within 7 days prior toadministration of vaccination (Day 1) in this study. Participants may be re-evaluatedonce all symptoms have resolved.
7. History of severe adverse reaction associated with a vaccine and/or severe allergicreaction (eg, anaphylaxis) or contraindications to any component of the studyintervention(s).
8. History of, or positive screening test for human immunodeficiency virus I or II.
9. Any clinically significant finding during screening or check-in that, in theInvestigator's judgment, results in an increased safety risk.
10. History of cerebral venous sinus thrombosis, antiphospholipid syndrome, or a historyof heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2).
11. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia;recurrent severe infections and use of immunosuppressant medication within the past 3months, except topical and inhaled steroids, or short-term oral steroids (courselasting ≤14 days or ≤20 mg/day).
12. History of receiving blood transfusion, blood products, immunoglobulin, or immunestimulants within 3 months prior to Day 1.
13. Is currently participating in any other study or has received any investigational drugin the last 6 weeks or 5× the half-life of the drug (whichever is longer) prior toscreening.
14. For female participants of childbearing potential who are pregnant (positive pregnancytest at the screening or check-in), currently breastfeeding, or attempting toconceive.
15. Any addiction that may interfere with the participant's ability to comply with trialprocedures.
16. Inability to be venipunctured or tolerate venous, IM, SC, or ID puncture.
17. Have a rash, dermatological condition, tattoo, or any other abnormality at theinjection site that may interfere with injection site reaction rating. Investigatordiscretion will be permitted with this exclusion criterion.
18. Use of prophylactic medications (e.g., antihistamines [H1 receptor antagonists],nonsteroidal anti-inflammatory drugs [NSAIDs], systemic glucocorticoids, non-opioidand opioid analgesics) within 24 hours prior to the vaccination to prevent or pre-emptsymptoms due to vaccination.
19. Any condition or abnormal baseline findings or any other unspecified reason, which inthe Investigator's judgment might increase the risk to the participant or decrease thechance of obtaining satisfactory data needed to achieve the objective of the study.
20. Participants identified as an Investigator or employee of the Investigator or clinicalsite with direct involvement in the proposed study, or identified as an immediatefamily member (i.e., parent, spouse, natural or adopted child) of the Investigator, oremployee with direct involvement in the proposed study, or any employees of theSponsor company.