A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL

Exclusion Criteria

• •The volunteer may not enter the study if any of the following apply:
• •Has mucosal or conjunctival PKDL
• •Has had treatment for PKDL within 21 days
• •Receipt of a live attenuated vaccine within 60 days or other vaccine within 14 days of screening
• •Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
• •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or a history of severe or multiple allergies to drugs or pharmaceutical agents
• •Any history of severe local or general reaction to vaccination as defined as
• •Local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
• •General: fever ≥ 39.5°C within 48 hours, anaphylaxis, bronchospasm, laryngeal oedema, collapse, convulsions or encephalopathy within 48 hours
• •Females - pregnancy, less than 12 weeks postpartum, lactating or willingness/intention to become pregnant during the study and for 3 months following vaccination.
• •Seropositive for hepatitis B surface antigen (HBsAg) or Hepatitis C (antibodies to HCV)
• •Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
• •Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months
• •Tuberculosis, leprosy, or malnutrition (malnutrition in adults defined as a BMI \<18.5, and in adolescents (12-17yrs) as a Z score cut-off value of \<-2 SD).
• •Any other significant disease, disorder or finding, which, in the opinion of a medically qualified Clinical Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study
• •Unlikely to comply with the study protocol