Leishmaniasis Infections and Infestations
Conditions
Interventions
The study involves patient volunteers receiving a single intramuscular injection of a recombinant adenovirus vaccine encoding two proteins derived from the Leishmania parasite. The first 8 adult volun
the subsequent 8 adult volunteers will receive 7.5x10(10)vp
the 8 adolescents will receive one of these doses. Doses will be administered at a single time point to patients with persistent PKDL. Prior to therapeutic vaccination, on the day of vaccination and a
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults: 1. Aged 18 to 50 years on the day of screening 2. Females must be unmarried, single, or widowed 3. Willing and able to give written informed consent Adolescents: 1. Aged 12 to 17 years on the day of screening 2. Female adolescents must be unmarried 3. Written informed consent must be obtained from a parent All Participants: 1. Uncomplicated PKDL of > 6 months duration 2. Available for the duration of the study 3. In otherwise good health as determined by medical history, physical examination, results of screening tests and the clinical judgment of a medically qualified Clinical Investigator 4. Judged, in the opinion of a medically qualified Clinical Investigator, to be able and likely to comply with all study requirements as set out in the protocol 5. Willing to undergo screening for HIV, Hepatitis B and Hepatitis C 6. For females only, willing to undergo urinary pregnancy tests on the day of screening, on the day of vaccination (prior to vaccination) and 28 and 90 days after vaccination
Exclusion criteria
Exclusion criteria: The volunteer may not enter the study if any of the following apply: 1. Has mucosal or conjunctival PKDL 2. Has had treatment for PKDL within 21 days 3. Is negative for antibodies in the RK39 strip test 4. Receipt of a live attenuated vaccine within 60 days or other vaccine within 14 days of screening 5. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate 6. 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 7. Any history of severe local or general reaction to vaccination as defined as: 7.1. 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 7.2. General : fever = 39.5°C within 48 hours, anaphylaxis, bronchospasm, laryngeal oedema, collapse, convulsions or encephalopathy within 48 hours 8. Females – pregnancy, less than 12 weeks postpartum, lactating or willingness/intention to become pregnant during the study and for 3 months following vaccination. 9. Seropositive for hepatitis B surface antigen (HBsAg) or Hepatitis C (antibodies to HCV) 10. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis 11. 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 12. Tuberculosis, leprosy, or malnutrition 13. 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 14. Unlikely to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, as measured by clinical assessment of local and systemic effects (e.g. injection site pain, headache, vomiting) following vaccination. To be assessed immediately after vaccination and at days 1, 3, 7, 21, 42 and 90 post vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes to PKDL lesions, via photographing them 2. Measures of immune response (measured by analysis of blood samples using ELISA, ELISPOT, RNASeq or other techniques) To be assessed immediately after vaccination and at days 1, 3, 7, 21, 42 and 90 post vaccination. | — |
Countries
Sudan
Outcome results
None listed