A Clinical Study to Develop a Controlled Human Infection Model Using Leishmania Major-infected Sand Flies

Exclusion Criteria

• •Receipt of any vaccine within 21 days of screening
• •Administration of immunoglobulins and/or any blood products within the three months preceding the planned study.
• •History of significant allergic disease/atopy (e.g. eczema, hay fever, asthma) or reactions; or a history of severe or multiple allergies to drugs or pharmaceutical agents, as judged by the clinical investigators
• •Any significant chronic skin condition as judged by the clinical investigators
• •Any history of confirmed Leishmaniasis infection
• •Any history of travel within the last 30 days to regions where Leishmania major-transmitting sand flies are endemic\*.
• •Any history of more than 30 continuous days stay in regions where Leishmania major-transmitting sand flies are endemic within the last 10 years\*.
• •Any history of severe local or general reaction to insect bites, 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, anaphylaxis, bronchospasm, laryngeal oedema, collapse, convulsions or encephalopathy within 48 hours
• •Any history of anaphylaxis
• •Females - current pregnancy, less than 12 weeks postpartum, lactating or willingness/intention to become pregnant during the study.
• •Any clinically significant abnormal finding on screening biochemistry or haematology blood tests as judged by study investigators
• •Total IgE (immunoglobulin E) levels \> 214 IU/ml
• •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
• •A diagnosis of diabetes type 1 or type 2 or significantly raised HbA1c (\>48mmol/mol)
• •Active Tuberculosis, leprosy, or malnutrition
• •Any significant chronic illness requiring hospital specialist input as judged by study investigators
• •Any significant psychiatric conditions as judged by general practitioner and/or study clinical team
• •Unlikely to comply with the study protocol
• •Participating in significant current or recent research (involving an investigational medicinal product or other significant intervention) within the past 3 months (as judged by study investigators)
• •Any other significant disease, disorder, finding or medical history, which, in the opinion of a medically qualified Clinical Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study