Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults

Exclusion Criteria

• •5. Non-smoker or occasional smoker, defined as smoking less than 10 nicotine-containing cigarettes/ vapes/cigars/pipe fills per week.
• •6. Contraception and childbearing/conception potential: only female participants with non-childbearing potential will be included. Male participants in a relationship with a female partner of childbearing potential must be willing to use a double contraceptive method together with their female partner for at least 4 weeks before and 12 weeks after the IMP injection at Visit 2 (day 1).
• •7. Body mass index (BMI) ≥ 17.0 kg/m2 and ≤ 35.0 kg/m2.
• •1. History of RSV, hMPV, and/or PIV3 infection affecting the participant and/or the participant's household in the previous 12 months.
• •2. History of autoimmune disease (AID) or possibly autoimmune disease (pAID) requiring therapeutic intervention, even if stable and well controlled, including, but not limited to, systemic lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, temporal arteritis, psoriasis, insulin-dependent diabetes mellitus, celiac disease.
• •3. Confirmed or suspected immunodeficiency, even if stable and well controlled.
• •4. Ongoing severe asthma. Other allergic diseases (e.g., allergic rhinitis, atopic dermatitis / eczema, mild to moderate asthma, food allergies) are allowed at the investigator's or delegate's discretion.
• •5. History of significant allergic reaction (e.g., anaphylaxis, hypersensitivity, angioedema) to medication or food or known allergy to vaccine, or any excipients in the formulation, and latex.
• •6. History of severe AE associated with vaccine administration.
• •7. Ongoing disorders of coagulation, which contraindicate IM injections.
• •8. Donation or loss of ≥ 500 mL whole blood on the previous 2 months, and/or donation of plasma in the previous 1 week, and/or intention to donate blood or plasma during the study.
• •9. Positive serum test results indicating ongoing HIV, HBV and/or HCV infection, and/or documented ongoing HIV, HBV, or HCV infection.
• •10. Other poorly controlled and/or impactful chronic disease. A disease is defined as poorly controlled if it requires meaningful change in therapy and/or unplanned medical visit(s) in the previous 3 months. A disease is defined as impactful if, in the investigator's judgment, it meaningfully affects the participant's ability to manage self-care and/or activities of daily living.
• •11. Disease expected to prevent completion of the study (i.e. to rapidly deteriorate within the timeframe of the study).
• •12. Prior treatments.
• •1. Receipt of licensed RSV vaccine and/or enrollment in clinical trials(s) evaluating investigational RSV, hMPV, PIV3, and/or molecular clamp-based vaccine candidates at any time, unless it was documented that the participant received a placebo.
• •2. Other investigational drug or vaccine received in the previous 6 months.
• •3. Chemotherapy, radiotherapy, and/or other immunosuppressive medication (including biologics) received in the previous 6 months.
• •4. IgGs or any blood product received in the previous 3 months.
• •5. Systemic corticosteroids (oral/intravenous/IM) at doses equivalent to ≥ 20 mg prednisone per day received for ≥ 14 days, even if not consecutive, during the previous 3 months. Inhaled/nebulized, intra-articular, intra-bursal, skin, and eye topical corticosteroids are permitted.
• •6. Received or plan to receive licensed non-live vaccine(s) for the period starting 2 weeks before to 4 weeks after of the study IMP injection or licensed live vaccine(s) for the period starting from 4 weeks before to 4 weeks after the study IMP injection. Pandemic or emergency vaccines are always allowed as per country guidelines.
• •13. Clinically meaningful abnormal finding from physical examination, vital sign assessment, electrocardiogram (ECG), safety laboratory test results. If deemed appropriate, the investigator or delegate may repeat these assessments.
• •14. History of alcohol abuse in the previous year determined at the investigator's discretion.
• •15. History of recreational drug abuse in the previous year and/or positive test for drugs of abuse at Visit 2 (day 1), unless there is an explanation acceptable to the investigator (e.g., the participant has informed in advance that he/she consumed a prescription or over-the-counter product that contained the detected drug).
• •16. Intention to participate in any investigational drug/vaccine/medical device clinical trial at any time throughout the planned duration of this study.
• •17. Presence of tattoo, scarring, skin discoloration, or any other skin disturbances at the injection site which may interfere with effective assessment of the injection site.
• •18. Intention to move to a location that would prevent participating in the study until study end.
• •19. Any other reason which would prevent the participant from participating in the study or interfere with the participant's compliance with study procedures.