A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL (NCT03969134) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL
Sudan86 participantsStarted 2020-04-06
Plain-language summary
This trial is designed to assess the therapeutic efficacy and safety of CHAd63-KH, a new candidate Leishmania vaccine, in patients with persistent PKDL. 100 participants will be randomly assigned (50 participants in each arm) to receive placebo or ChAd63-KH 7.5 x10(10)vp. Doses will be administered at a single time point.
Who can participate
Age range12 Years – 50 Years
SexALL
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Inclusion Criteria:
* The volunteer must be:
* Aged 12 to 50 years on the day of screening
* 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 and assent from them.
All Participants
* Uncomplicated PKDL of \> 6 month's duration
* Available for the duration of the study
* 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
* 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
* Willing to undergo screening for HIV, Hepatitis B and Hepatitis C
* Leishmania PCR positive on the screening skin biopsy
* For females only, willing to undergo urinary pregnancy tests on the day of screening, on the day of vaccination (prior to vaccination) and 7 and 42 days after vaccination.
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 plan…
What they're measuring
1
To assess the number of participants with treatment-related adverse events as defined in the clinical trial protocol V1.0.
Timeframe: 24 months
2
To assess the therapeutic efficacy of CHAd63-KH, a new candidate, in patients with PKDL by clinical judgement of PKDL lesion reduction.