A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar

Exclusion Criteria

• •1. Participant with major congenital abnormalities which in the opinion of investigator may affect the subject's participation in the study.
• •2. Participant concomitantly enrolled or scheduled to be enrolled in another trial.
• •3. Positive rapid test for HIV 1-2 confirmed by a positive blood test for human immunodeficiency virus (positive antibodies to HIV 1/2).
• •4. Participant seropositive for hepatitis B virus surface antigen (HBsAg).
• •5. Participant seropositive for hepatitis C virus (Antibodies to HCV).
• •6. Participant with active or chronic Schistosomiasis infection defined by a positive result for microscopy (Urine filtration, Kato-Katz (KK)) and point-of-care - circulating cathodic antigen (POC -CCA) and/or real-time PCR.
• •7. Participant with soiled transmitted helminths infections (STH) as diagnosed by microscopy (KK) and/or real-time PCR.
• •8. Participant with malaria infection/malaria as diagnosed by the blood smear.
• •9. Any other confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections.
• •10. Body mass index (BMI) ≥ 35 kg/m2
• •11. Chronic use of systemic steroids (\>2 mg/kg/day or \>20 mg/day prednisolone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs.
• •12. Receipt of blood or blood-derived products in the past 3 months.
• •13. Participant who has received other vaccines 4 weeks prior to test vaccination or plans to receive any vaccine within 4 weeks of last dose of study vaccine, exception made for COVID-19 vaccines.
• •14. Known history of allergy to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial.
• •15. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections/blood extractions.
• •16. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives and compromise the health of the volunteers.
• •17. Any female participant who is lactating\*, pregnant or planning for pregnancy\*\* during the course of study period.
• •18. Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the individual's ability to participate in the trial.
• •20. Individuals who were research staff involved with the clinical study or family/household members of research staff.