| Eligibility |
Inclusion Criteria:
The patient volunteer must be:
- Aged 12 to 50 years on the day of screening
- Have had VL and have been cured following a standard regimen of SSG / PM
- Females must be unmarried, single, or widowed
- Willing and able to give written informed consent
- For adolescents aged 12 to 17 years on the day of screening written informed consent
from a parent must be obtained.
All Participants
- Uncomplicated VL responsive to SSG / PM treatment
- Have relatively normal blood values in the setting of VL, defined as hemoglobin >5.0
g/dL, white blood cells >1.0 x10(9)/L, platelets >40 x10(9)/L, liver function tests <
x5 normal, Creatinine <1.5 mg/dL
- Available for the duration of the study
- Without any other significant health problems as determined by medical history,
physical examination, results of screening tests and the clinical judgment of a
medically qualified Clinical Investigator
- Negative for malaria on blood smear
- 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
- Negative for human immunodeficiency virus (HIV), Hepatitis B and Hepatitis C
- For females only, willing to undergo urinary pregnancy tests on the day of screening,
on the day of vaccination (prior to vaccination) and 3, 6, 9 and 12 months after
vaccination.
Exclusion Criteria:
The volunteer may not enter the study if any of the following apply:
- Has HIV/VL coinfection
- Has had previous treatment for VL with relapse
- 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
hepatitis C virus)
- Significant abnormal finding (in the setting of VL, see definitions in Inclusion
criteria) on entry 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
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