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 range

12 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the number of participants with treatment-related adverse events as defined in the clinical trial protocol V1.0.

Timeframe: 24 months

To assess the therapeutic efficacy of CHAd63-KH, a new candidate, in patients with PKDL by clinical judgement of PKDL lesion reduction.

Timeframe: 24 months

Trial details

NCT IDNCT03969134

SponsorUniversity of York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-31

View on ClinicalTrials.gov More Leishmaniasis, Cutaneous trials