Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT07280858
Eligibility Criteria:
Inclusion Criteria:
Age
1. For Stage 1, participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
For Stage 2, participant must be 18 years of age and older, at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2. Participants who are healthy as determined by medical evaluation including medical history, vital signs, physical examination, clinical laboratory tests, and medical judgement of the investigator.
3. Participants who are willing and able to attend all scheduled visits and comply with all study procedures.
4. Body mass index (BMI) within the range of 18.5-32.0 kg/m2 (revised) at screening
5. Participants who received a primary series and at least one booster dose of an authorized COVID-19 vaccine at least 24 weeks prior to the 1st study vaccination.
Sex and Contraceptive/Barrier Requirements
6. All participants must agree to be abstinent from heterosexual intercourse or agree to consistently use at least one acceptable method of contraception from at least 4 weeks prior to the 1st study vaccination to 12 weeks after the last study vaccination (See Appendix 10.4 for detailed contraceptive methods).
7. Women of childbearing potential (WOCBP) with a negative urine or serum pregnancy test at screening.
\* Female participants who are surgically sterile (e.g., having undergone a full hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal with at least 12 months amenorrhoea not considered to be caused by any other medical condition, are not subject to a pregnancy test.
Informed Consent
8. Participants who are capable of giving signed informed consent as described in Appendix 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol before initiation of any trial-specific procedures.
Exclusion Criteria:
Medical Conditions
1. Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature \>38°C), or acute illness within 24 hours prior to the 1st study vaccination. Prospective participants with these conditions cannot be included until 24 hours after resolution.
2. Concurrent or a history of virologically or serologically confirmed SARS-CoV-2 infection, or suspected SARS-CoV-2 infection as determined by the investigator, within 24 weeks prior to the 1st study vaccination.
3. History of virologically or serologically confirmed SARS-CoV-1, or MERS disease.
4. History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
5. Any positive test results for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening.
6. History of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion.
7. History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis) to any vaccines or components of the study intervention.
8. History of neurologic diseases (e.g., Guillain-Barre syndrome, myelitis, or encephalomyelitis).
9. History of myocarditis, pericarditis or myopericarditis, as assessed by the investigator, indicating probable or possible myocarditis, pericarditis, or myopericarditis, or demonstrating clinically significant abnormalities that could affect participant safety or the interpretation of study findings.
10. History of malignancy within 1 year prior to first study vaccination, except for cutaneous non-melanoma malignancy, melanoma-in-situ, or cervical carcinoma in situ that have been fully treated with completed follow-up prior to screening. Malignancy considered to carry minimal risk of recurrence may also be permitted at the discretion of the investigator.
11. Significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results.
12. Any other conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g., alcohol or drug abuse, neurologic or psychiatric conditions).
13. Female participants who are pregnant or breastfeeding.
Prior/Concomitant therapy
14. Receipt of any COVID-19 vaccination including investigational vaccines within 24 weeks prior to the 1st study vaccination or planned receipt at any time during the study period.
15. Receipt of any vaccinations intended to prevent SARS-CoV-1 or MERS, including investigational vaccines.
16. Receipt of any vaccine within 4 weeks prior to the 1st study vaccination or planned receipt of any vaccine through 4 weeks after the last study vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the 1st study vaccination.
17. Receipt of any immunoglobulins and/or blood-derived products within 12 weeks prior to the 1st study vaccination or planned receipt at any time during the study period.
18. Receipt of immunosuppressive therapy, such as any use of anti-cancer chemotherapy or radiation therapy; or chronic use of systemic corticosteroid (≥10 mg prednisone/day or equivalent more than 14 consecutive days) within 12 weeks prior to the 1st study vaccination and throughout the entire study period. The use of intranasal, inhaled, topical, or intra-articular corticosteroid is permitted.
Prior/Concurrent Clinical Study Experience
19. Participation in another clinical study and receipt of study intervention within 4 weeks prior to the 1st study vaccination, or concurrent, planned participation in another clinical study with study intervention during this study period.
Other Exclusions
20. Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.
21. Donation of ≥450mL of blood product within 4 weeks prior to screening, or planned donation of blood product from enrollment through 12 weeks after the last study vaccination.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07280858
Study Brief:
Protocol Section:
NCT07280858