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:

  • Conditions:
  • Age: Between 18 years - 49 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures
    2. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study)
    3. Capable of giving signed informed consent

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

    1. 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. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
    3. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
    4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
    5. Women who are pregnant or breastfeeding
    6. 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
    7. 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
    8. 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
    9. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study
    10. Vaccination with any influenza vaccine within 6 months (175 days) before study intervention administration
    11. Any participant who has received or plans to receive a modRNA-platform SARS-CoV-2 vaccine within 60 days of Visit 1
    12. 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.