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Leishmaniasis, CutaneousPhase 2NCT03969134

A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL

A Phase 2 study testing ChAd63-KH in people with Leishmaniasis, Cutaneous, run by University of York at 1 site in Sudan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 50 years
Conditions the study is for
Leishmaniasis, Cutaneous
What is being tested?
ChAd63-KH
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteSudan
Study dates
6 Apr 2020to 28 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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 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
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  • 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 HCV)
  • Any clinically significant abnormal finding on screening 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

Trial locations and contacts

1 site in 1 country.

Sudan1 site

  • Institute of Tropical Medicine

    Doka, Gedarif

Other trials in Sudan

About this study

Official title: A Phase IIb Study to Assess the Safety, Efficacy and Immunogenicity of the Leishmania Vaccine ChAd63-KH in Post-kala Azar Dermal Leishmaniasis

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.

Read the detailed description

This study is a randomised, double blinded, placebo controlled trial 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 intramuscular injection into the deltoid region. Doses will be administered at a single time point. Volunteers aged between 12-50 years with persistent PKDL will be recruited at Professor El-Hassan's Centre for Tropical Medicine, Dooka, Gedarif State, Sudan, and will be followed up for 120 days after the dosing visit. The trial is planned to run for 24 months.

Secondary objectives are as follows:

  1. To compare the humoral and cellular immune responses generated by the candidate vaccine in patients with persistent PKDL.
  2. To observe any clinical changes in the cutaneous PKDL disease over a 120 day period following vaccination
Being tested
ChAd63-KH, Placebo
Medical subject headings
Leishmaniasis, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChAd63-KHBiological

    The vaccine will be injected intramuscularly into the arm.

  • PlaceboOther

    The placebo will be injected intramuscularly into the arm.

Study groups in NCT03969134
Study groupRoleWhat they receive
Vaccine armActive comparatorChAd63 KH 7.5x1010 vp, single dose, by IM injection
Receives: Biological: ChAd63-KH
PlaceboPlacebo comparatorNormal Saline, single dose, by IM injection
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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.

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

    Measured: 24 months

Secondary outcomes (3)

  1. Immune responses by presence of interferon gamma producing T cells

    To identify cellular immune responses generated by the candidate vaccine in patients with persistent PKDL using a gamma interferon ELISpot assay

    Measured: 24 months

  2. Immune responses by presence of serum antibodies against Leishmania peptides

    To identify humoral immune responses generated by the candidate vaccine in patients with persistent PKDL using a gamma interferon ELISpot assay

    Measured: 24 months

  3. Clinical changes in PKDL disease

    To observe any changes in the appearance of the cutaneous PKDL disease over a 120 day period following vaccination.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start6 Apr 2020
  3. Primary completion31 Aug 2022
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, double blinded, placebo controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03969134
Sponsor's protocol ID
LEISH2b
Status last verified
May 2023
First submitted
22 May 2019
Last updated
26 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Younis BM, Wiggins R, Khalil EAG, Osman M, Santoro F, Sonnati C, Keding A, Novedrati M, Montesi G, Noureldein A, Elmukashfi ETA, Mustafa AE, Alamin M, Saeed M, Salman K, Suliman AJ, Musa AEA, Layton AM, Lacey CJN, Kaye PM, Musa AM. A randomized, double-blind phase 2b trial to evaluate efficacy of ChAd63-KH for treatment of post kala-azar dermal leishmaniasis. Mol Ther Methods Clin Dev. 2024 Jul 30;32(3):101310. doi: 10.1016/j.omtm.2024.101310. eCollection 2024 Sep 12.

    PubMed 39253357

  • Lacey C, Musa A, Khalil ET, Younis B, Osman M, Wiggins R, Keding A, Kaye P. LEISH2b - A phase 2b study to assess the safety, efficacy, and immunogenicity of the Leishmania vaccine ChAd63-KH in post-kala azar dermal leishmaniasis. Wellcome Open Res. 2022 Aug 3;7:200. doi: 10.12688/wellcomeopenres.17951.1. eCollection 2022.

    PubMed 37252616

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ChAd63-KH in people with Leishmaniasis, Cutaneous, run by University of York at 1 site in Sudan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the number of participants with treatment-related adverse events as defined in the clinical trial protocol V1.0. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03969134, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.

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