Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients

Exclusion Criteria

• •Individuals who meet ANY of the following criteria will be considered ineligible:
• •1. History of infection with Mycobacterium leprae.
• •2. History of exposure to experimental products containing GLA-SE.
• •3. History of active or documented latent tuberculosis.
• •4. History of previous infection with other non-tuberculous mycobacteria.
• •5. Participation in another trial protocol and/or receipt of any trial products in the last 3 months prior to screening.
• •6. Treatment with immunosuppressive drugs (eg oral or injected steroids, such as prednisone; high doses of inhaled steroids) or cytotoxic therapies (eg chemotherapy or radiation) within 6 months prior to screening.
• •7. Have received blood transfusion within the last 3 months prior to screening.
• •8. Donated blood products (platelets, whole blood, plasma, etc.) within the last month prior to screening.
• •9. Received any vaccine 1 month prior to screening or planned immunizations during the follow-up from D0 to D63 and D154 to D168.
• •10. History of autoimmune disease or other immunosuppressive causes.
• •11. History of any other acute or chronic decompensated disease (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, haematological, metabolic or renal disease, uncontrolled hypertension) or use of medication that, in the opinion of the Principal Investigator, may interfere with safety or immunogenicity of the vaccine.
• •12. Rash, tattoos or any other dermatological condition that may adversely affect the injection site of the vaccine or interfere with its evaluation.
• •13. Body mass index (BMI) ≥ 32.
• •14. Systemic arterial hypertension (systolic \> 150 or diastolic \> 95).
• •15. History of psychiatric illness with current medication use.
• •16. Alcohol or drug abuse in the last 6 months prior to screening.
• •17. Chronic smoker (1 pack or more per day).
• •18. History of previous anaphylaxis or severe allergic reaction to unknown vaccines or allergens.
• •19. Individuals who do not wish to cooperate with all procedures recommended in the study protocol.
• •Individuals who meet ANY of the following criteria will be considered ineligible:
• •1. Previous treatment for leprosy.
• •2. History of exposure to experimental products containing GLA-SE.
• •3. History of active or documented latent tuberculosis.
• •4. History of previous infection with other non-tuberculous mycobacteria.
• •5. Participation in another trial protocol and/or receipt of any trial products in the last 3 months prior to screening.
• •6. Treatment with immunosuppressive drugs (eg oral or injected steroids, such as prednisone; high doses of inhaled steroids) or cytotoxic therapies (eg chemotherapy or radiation) within 6 months prior to screening.
• •7. Have received blood transfusion within the last 3 months prior to screening.
• •8. Donated blood products (platelets, whole blood, plasma, etc.) within the last month prior to screening.
• •9. Received any vaccine 1 month prior to screening or planned immunizations during the follow-up from D0 to D63 and D154 to D168.
• •10. History of autoimmune disease or other immunosuppressive causes.
• •11. History of any other acute or chronic decompensated disease (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, haematological, metabolic or renal disease, uncontrolled hypertension) or use of medication that, in the opinion of the Principal Investigator, may interfere with safety or immunogenicity of the vaccine.
• •12. Rash, tattoos or any other dermatological condition that may adversely affect the injection site of the vaccine or interfere with its evaluation.
• •13. Body mass index (BMI) ≥ 32.
• •14. Systemic arterial hypertension (systolic \> 150 or diastolic \> 95).
• •15. History of psychiatric illness with current medication use.
• •16. Alcohol or drug abuse in the last 6 months prior to screening.
• •17. Chronic smoker (1 pack or more per day).
• •18. History of previous anaphylaxis or severe allergic reaction to unknown vaccines or allergens.
• •19. Individuals who do not wish to cooperate with all procedures recommended in the study protocol.
• •Vital signs are performed after participants have sat for five minutes without hot or cold drinks or smoking for the past five minutes. Vital signs can be performed up to three times to allow resolution of transient conditions.