Safety and Immunogenicity of ChulaCov19 BNA159 mRNA Vaccine

Exclusion Criteria

• •9. Presence of clinically significant medical history, unstable chronic or acute disease, or physical, or laboratory findings that, in the opinion of the PI may potentially increase the expected risk of exposure to the investigational vaccine, compromise the safety of the participant, or interfere with any aspect of study conduct or interpretation of results. This will include any thrombocytopenia or bleeding disorder contraindicating IM vaccination.
• •10. Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• •11. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• •12. Participant has previously participated in an investigational study involving LNPs (a component of the investigational vaccine assessed in this trial).
• •13. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.
• •14. Close contact with anyone known to have SARS-CoV-2 infection within 10 days prior to vaccine administration.
• •15. Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
• •* Uncontrolled hypertension
• •* Diabetes mellitus
• •* Cardiovascular disease
• •* Chronic pulmonary disease
• •* Asthma
• •* Chronic liver disease
• •* Stage 3 or worse chronic kidney disease (glomerular filtration rate \<60 mL/min/1.73 m2)
• •* BMI \>30 kg/m2
• •* Individuals with a history of autoimmune disease
• •Prior/Concomitant Therapy:
• •16. Previous vaccination with any coronavirus vaccine at any time prior to the study or planned receipt of any other licensed or experimental SARS-CoV-2 vaccine within 50 days of receipt of the first study vaccination.
• •17. Receipt of medications intended to prevent COVID-19.
• •18. Chronic use (more than 14 continuous days) of or anticipated need to use, within the next 6 months, of any medications that may be associated with impaired immune responsiveness or with immunosuppression.
• •19. Receipt of immunoglobulins or blood products within 3 months of first vaccination.
• •Diagnostic Assessments:
• •20. Positive on SAR-CoV-2 -RBD and/or -N antibody IgG/IgM at screening visit
• •21. Positive test for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV Abs) at the screening visit.
• •Other Exclusions:
• •22. Is a participant at high risk of SARS-CoV-2 exposure in the opinion of the PI (e.g., healthcare workers, active health care workers with direct patient contact, emergency response personnel).
• •23. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.