Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults

Exclusion Criteria

• •3. Able and willing to complete the informed consent process.
• •4. Available for clinic visits for 52 weeks after last product administration.
• •5. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• •6. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) of 18 to 35 within the 56 days prior to enrollment.
• •Laboratory Criteria within 56 days before enrollment:
• •7. White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval.
• •8. Total lymphocyte count \>= 800 cells/microL.
• •9. Platelets = 125,000 - 500,000 cells/microL.
• •10. Hemoglobin within institutional normal range or accompanied by the PI or designee approval.
• •11. Alanine aminotransferase (ALT) \<= 1.25 X institutional upper limit of normal (ULN).
• •12. Aspartate aminotransferase (AST) \<= 1.25 X institutional ULN.
• •13. Alkaline phosphatase (ALP) \<1.1 X institutional ULN.
• •14. Total bilirubin within institutional normal range or accompanied by the PI or designee approval.
• •15. Serum creatinine \<= 1.1 X institutional ULN.
• •16. Negative for HIV infection by an FDA-approved method of detection
• •Criteria applicable to women of childbearing potential:
• •17. Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) on the day of enrollment.
• •18. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study.
• •A volunteer will be excluded if one or more of the following conditions apply:
• •1. Breast-feeding or planning to become pregnant during the study.
• •2. More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment.
• •3. Blood products within 16 weeks prior to enrollment.
• •4. Any vaccine, including COVID-19 vaccines, received within 4 weeks prior to enrollment.
• •5. Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
• •6. Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
• •7. Current anti-TB prophylaxis or therapy.
• •8. Known immediate hypersensitivity to any component of the study product, including polyethylene glycol (PEG).
• •9. Confirmed past NiV infection, prior residence in (\>6 months), or planned travel for any length of time during the study to countries where NiV infection is endemic, eg. Bangladesh, India, Philippines.
• •Volunteer has a history of any of the following clinically significant conditions:
• •10. Serious reactions to vaccines that preclude receipt of the study vaccination, including allergic reaction (anaphylaxis, urticaria or allergic reaction requiring medical intervention) to SARS-CoV-2 mRNA vaccines, as determined by the investigator
• •11. History of myocarditis and/or pericarditis
• •12. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
• •13. Asthma that is not well controlled
• •14. Diabetes mellitus (type I or II), with the exception of gestational diabetes
• •15. Thyroid disease that is not well controlled
• •16. Idiopathic urticaria within the past year
• •17. Autoimmune disease or immunodeficiency
• •18. Hypertension that is not well controlled
• •19. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
• •20. Malignancy that is active or history of malignancy that is likely to recur during the period of the study
• •21. Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
• •22. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
• •23. Guillain-Barre Syndrome
• •24. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject s ability to give informed consent, including but not limited to clinically significant forms of: infectious diseases, drug or alcohol abuse, autoimmune diseases, psychiatric disorders, or heart disease.