Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2

Inclusion Criteria

• •1. Able and willing to complete the informed consent process, including an Assessment of Understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered correctly.
• •2. 18-65 years old, inclusive, on day of enrollment.
• •3. Agrees to comply with planned study procedures and be available for clinic follow-up through the last clinic visit.
• •4. Willing to disclose prior SARS-CoV-2 infection and/or prior vaccination (via COVID-19 vaccination card or other reliable record).
• •5. Previously received at least one COVID-19 immunization with the last dose \> 4 months prior to enrollment.
• •6. Willing to forego any non-study vaccinations from time of study enrollment to at least 28 days from the dose of study vaccination.
• •7. Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the 302-23-101 study team are required.
• •8. In good general health according to the clinical judgement of the site investigator.
• •9. Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator. Clinically significant hematology and/or blood chemistry laboratory results that meet the definition of Grade ≥2 abnormality will prevent the inclusion in the trial. Investigators should reference Appendix D, FDA guidance, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
• •10. Body mass index of 18-35 kg/m2, inclusive, at screening
• •11. Negative results for HIV infection by an (US) Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
• •12. Negative for anti-Hepatitis C antibodies (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV antibodies are detected.
• •13. Negative for Hepatitis B surface antigen.
• •14. For a volunteer assigned female sex at birth and capable of becoming pregnant or a volume assigned male sex at birth:
• •Volunteers who were assigned female sex at birth and are of reproductive potential must agree to use an acceptable method of contraception from at least 21 days prior to study Day 0 until at least 90 days after vaccination. Volunteers who are physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with individuals born male must use an acceptable method of contraception during this period. Acceptable methods of contraception include a sterile sexual partner, hormonal contraceptives (combined estrogen and progestogen containing), hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence.
• •Has negative β-HCG (beta human chorionic gonadotropin) pregnancy test (urine or serum) at screening and prior to study product administration.
• •Sexually active participants assigned male sex at birth must be willing to use an effective method of contraception (i.e., condoms or be anatomically sterile) from Day of Injection through Day 28.