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Leishmaniasis, CutaneousPhase 2Leish2aNCT02894008

A Study of a New Leishmania Vaccine Candidate ChAd63-KH

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 is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in patients with persistent post kala azar dermal leishmaniasis (PKDL). This is a Phase II trial in patients with PKDL, to assess the safety and compare the humoral and cellular immune responses generated by the candidate vaccine in… 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSudan
Study dates
Nov 2016to 31 Dec 2019
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

  • Adults
  • The volunteer must be:
  • Aged 18 to 50 years on the day of screening
  • Females must be unmarried, single, or widowed
  • Willing and able to give written informed consent
  • Adolescents
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  • Aged 12 to 17 years on the day of screening
  • Female adolescents must be unmarried
  • Written informed consent must be obtained from a parent
  • 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
  • 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
  • Is negative for antibodies in the RK39 strip test
  • 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
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  • 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 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
  • 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

  • Centre for Tropical Medicine

    Doka, Gedarif

Other trials in Sudan

About this study

Official title: A Phase IIa Safety Study to Assess the Safety and Immunogenicity of a New Leishmania Vaccine Candidate ChAd63-KH

This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in patients with persistent post kala azar dermal leishmaniasis (PKDL).

This is a Phase II trial in patients with PKDL, to assess the safety and compare the humoral and cellular immune responses generated by the candidate vaccine in patients, and observe any clinical changes in the disease over a 42 day period following vaccination.

Study design: Eight adult volunteers will receive 1x10(10)vp and the subsequent eight volunteers will receive 7.5 x10(10)vp. Adolescents will be vaccinated with either 1x10(10)vp or 7.5 x10(10)vp, to be determined by evaluation of all available data after DSMB \& CTSC review.

Read the detailed description

This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in patients with persistent post kala azar dermal leishmaniasis (PKDL). With 95% of cases occurring in India, Bangladesh, Nepal, the Sudan and Brazil, visceral leishmaniasis (VL) is a disease of the poor. With an estimated 40,000 or more deaths annually, mostly children and young adults, VL ranks second only to malaria amongst parasitic infections for mortality, and as measured by DALYs lost, it ranks in the top ten infectious diseases globally. No effective vaccine has yet been developed for VL / PKDL despite significant research efforts.

The investigators have recently completed a successful first-in-human clinical trial of a new therapeutic vaccine for VL / PKDL (ChAd63-KH). This trial demonstrated safety of ChAd63-KH in healthy UK adult volunteers and immunogenicity against the two Leishmania antigens on par with that seen to other vaccine candidate antigens in clinical development for other diseases (e.g. malaria, HCV, Ebola). Following external peer review of the data generated during LEISH1, the investigators have been awarded further Wellcome Trust funding to progress this vaccine into Phase II clinical trials in patients with PKDL.

Study design: The first eight adult volunteers will receive 1x10(10)vp and, following DSMB and CTSC review, the subsequent eights adult volunteers will receive 7.5 x10(10)vp. Doses will be administered at a single time point. Adolescents will be vaccinated with either 1x10(10)vp or 7.5 x10(10)vp, to be determined by evaluation of all available data after DSMB \& CTSC review.

Objectives:

  1. To assess the safety of a new candidate Leishmania vaccine ChAd63- KH in patients with persistent PKDL. Secondary objectives:
  2. To compare the humoral and cellular immune responses generated by the candidate vaccine in patients with persistent PKDL.
  3. To observe any clinical changes in the cutaneous PKDL disease over a 42 day period following vaccination.
Being tested
ChAd63-KH
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-KHDrug

    ChAd63-KH in adults and adolescents with persistent PKDL.

Study groups in NCT02894008
Study groupRoleWhat they receive
ChAd63- KHExperimentalSingle intramuscular dose of ChAd63-KH, 1 x10(10)vp or, following safety review, 7.5 x 10(10)vp in adults
Receives: Drug: ChAd63-KH
ChAd63-KHExperimentalSingle intramuscular dose of ChAd63-KH, 1x10(10)vp or, following safety review, 7.5 x 10(10)vp in adolescents
Receives: Drug: ChAd63-KH

What is being measured

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

  1. Safety

    Safety of a new candidate Leishmania vaccine in patients with persistent PKDL, assessed by the occurrence of biochemical, haematological and physiological responses which meet the criteria for adverse events/serious adverse events as described in the clinical trial protocol (v1.55)

    Measured: 90 days

Secondary outcomes (2)

  1. Cellular immune responses

    To compare the humoral and cellular immune responses generated by the candidate vaccine in patients with persistent PKDL.

    Measured: 90 days

  2. Clinical changes in cutaneous PKDL disease

    To observe any clinical changes in the cutaneous PKDL disease over a 42 day period according to a clinical grading score following vaccination

    Measured: 42 days following vaccination

Timeline

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

  1. First posted9 Sep 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion30 Sep 2019
  4. Study completion31 Dec 2019

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02894008
Sponsor's protocol ID
2016-000369-22
Other IDs
2016
Acronym
Leish2a
Status last verified
Jan 2020
First submitted
1 Aug 2016
Last updated
28 Jan 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Younis BM, Osman M, Khalil EAG, Santoro F, Furini S, Wiggins R, Keding A, Carraro M, Musa AEA, Abdarahaman MAA, Mandefield L, Bland M, Aebischer T, Gabe R, Layton AM, Lacey CJN, Kaye PM, Musa AM. Safety and immunogenicity of ChAd63-KH vaccine in post-kala-azar dermal leishmaniasis patients in Sudan. Mol Ther. 2021 Jul 7;29(7):2366-2377. doi: 10.1016/j.ymthe.2021.03.020. Epub 2021 Mar 27.

    PubMed 33781913

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 17 inclusion and 17 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 28 Jan 2020. 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. 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?

Safety (time frame: 90 days). 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 NCT02894008, which also lists 1 linked publication.

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 28 Jan 2020.

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