A Phase 1 Placebo-Controlled Randomized Observer-Blind Dose-Finding Study To Evaluate The Safety Tolerability And Immunogenicity Of Self-Amplifying RNA Vaccine Preparations Against Influenza In Healthy Individuals
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: Influenza
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Age: Between 18 years - 49 years
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Gender: Male or Female
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Other Inclusion Criteria:
- 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 signed informed consent
You may not be eligible for this study if the following are true:
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- 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
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
- 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
- Any participant who has had significant exposure to someone with laboratory-confirmed SARS-CoV-2 infection, COVID-19, or influenza in the 14 days prior to Visit 1
- Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the 10 days prior to Visit 1 that has not been confirmed as negative
- Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study
- Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study
- Vaccination with any influenza vaccine within 6 months (175 days) before study intervention administration
- Any participant who has received or plans to receive a modRNA-platform SARS-CoV-2 vaccine within 60 days of Visit 1
- Previous vaccination with an saRNA or an alphavirus replicon vaccine preparation
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.