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:
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Conditions: Covid-19
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Age: Between 18 - 85 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- 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
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures
- Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study
- Capable of giving personal signed informed consent
You may not be eligible for this study if the following are true:
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- 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.
- Participants with known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
- 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)
- Participants with receipt of medications intended to prevent COVID-19
- Previous clinical or microbiological diagnosis of COVID-19
- 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
- Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel).
- Immunocompromised participants with known or suspected immunodeficiency
- Participants with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- Previous vaccination with any coronavirus vaccine
- Participants who receive treatment with immunosuppressive therapy
- Participants who received blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- 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.