A Study to Assess Safety and Efficacy of a Leishmania Vaccine to Prevent Post Kala Azar Dermal Le… (NCT04107961) | Clinical Trial Compass
WithdrawnPhase 2
A Study to Assess Safety and Efficacy of a Leishmania Vaccine to Prevent Post Kala Azar Dermal Leishmaniasis (PKDL)
Stopped: The trial will be undertaken but the protocol will be substantially revised.
0Started 2023-10-01
Plain-language summary
The actual format of the anticipated LEISH3 trial is under review.
Who can participate
Age range12 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* H…
What they're measuring
1
Safety of single dose vaccination with ChAd63-KH
Timeframe: 12 months from vaccination
2
Efficacy of single dose vaccination with ChAd63-KH