A Study of RBI-4000 in Healthy Participants

Exclusion Criteria

• •1. History of diagnosis with rabies exposure, infection or disease.
• •2. History of rabies immunization (licensed or investigational) or human rabies immune globulin.
• •3. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• •4. Family history of congenital or hereditary immunodeficiency.
• •5. History of or current autoimmune disease.
• •6. History of any reaction or hypersensitivity likely to be exacerbated by any components of commercially available rabies vaccines.
• •7. Lymphoproliferative disorder or malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer, Ductal carcinoma in situ /Lobular carcinoma in situ (DCIS/LCIS).
• •8. History of Type I hypersensitivity reactions to any beta-lactam antibiotics.
• •9. Any acute or chronic, clinically significant disease, by history, physical examination, laboratory findings, subject personal report, and/or General Physician information.
• •10. Any history of myocarditis and/or pericarditis.
• •11. Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
• •12. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs including steroids during the period within 6 months prior to the vaccine dose.
• •13. Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
• •14. Concomitant or planned administration of antimalarial drugs, including hydroxychloroquine within 30 days of vaccination.
• •15. Current anti-tuberculosis prophylaxis or therapy.
• •16. Pregnant or lactating female participant.
• •17. Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
• •18. Participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.