A Phase 1/2 Placebo-Controlled Randomized Observer-Blind Dose-Finding Study to Describe the Safety Tolerability Immunogenicity and Potential Efficacy of SARS CoV 2 RNA Vaccine Candidates Against COVID 19 in Healthy Adults

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 - 85 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
    2. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures
    3. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study
    4. Capable of giving personal signed informed consent

You may not be eligible for this study if the following are true:

    1. Participants with other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
    2. Participants with known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
    3. Participants with history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
    4. Participants with receipt of medications intended to prevent COVID-19
    5. Previous clinical or microbiological diagnosis of COVID-19
    6. Individuals at high risk for severe COVID-19:
      • Hypertension
      • Diabetes mellitus
      • Chronic pulmonary disease
      • Asthma
      • Current vaping or smoking
      • History of chronic smoking within the prior year
      • BMI >30 kg/m2
      • Anticipating the needfor immunosuppressive treatment within the next 6 months
    7. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel).
    8. Immunocompromised participants with known or suspected immunodeficiency
    9. Participants with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention
    10. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
    11. Women who are pregnant or breastfeeding.
    12. Previous vaccination with any coronavirus vaccine
    13. Participants who receive treatment with immunosuppressive therapy
    14. Participants who received blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study
    15. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
    16. Previous participation in other studies involving study intervention containing lipid nanoparticles.

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.