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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03969134
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Paul Kaye, University of York

Brief 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.

Condition or disease Intervention/treatment Phase
Leishmaniasis, Cutaneous Biological: ChAd63-KH Other: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, double blinded, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Fifty volunteers receive a single intramuscular dose of ChAd63 KH 7.5x1010vp and 50 placebo. Investigators and the participant will be blinded. A pharmacist and nurse will prepare the injections. There will be stratification between patients aged 12-17, and patients aged 18-50, to ensure balanced randomisation. The pharmacist will be told which age strata the patient is in by a nurse, and will prepare the injection with the study nurse. There will be two series of sealed envelopes, one for each of the adolescent and adult cohorts. These envelopes will have external labelling, with the cohort, and successive cohort patient numbering. Each envelope contains randomisation to VACCINE or SALINE. The vaccine and placebo injections will be prepared in blacked-out syringes labelled with patient cohort number. The study nurse will take the prepared injection to the clinical team for administration. The syringe will be further labelled with the patient's initials, date and time of injection.
Primary Purpose: Treatment
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
Actual Study Start Date : April 6, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
Active Comparator: Vaccine arm
ChAd63 KH 7.5x1010 vp, single dose, by IM injection
Biological: ChAd63-KH
The vaccine will be injected intramuscularly into the arm.

Placebo Comparator: Placebo
Normal Saline, single dose, by IM injection
Other: Placebo
The placebo will be injected intramuscularly into the arm.




Primary Outcome Measures :
  1. To assess the number of participants with treatment-related adverse events as defined in the clinical trial protocol V1.0. [ Time Frame: 24 months ]
    To assess the number of participants with treatment-related adverse events as defined in the clinical trial protocol V1.0.

  2. To assess the therapeutic efficacy of CHAd63-KH, a new candidate, in patients with PKDL by clinical judgement of PKDL lesion reduction. [ Time Frame: 24 months ]
    To assess the therapeutic efficacy of CHAd63-KH, a new candidate, in patients with PKDL by clinical judgement of PKDL lesion reduction.


Secondary Outcome Measures :
  1. Immune responses by presence of interferon gamma producing T cells [ Time Frame: 24 months ]
    To identify cellular immune responses generated by the candidate vaccine in patients with persistent PKDL using a gamma interferon ELISpot assay

  2. Immune responses by presence of serum antibodies against Leishmania peptides [ Time Frame: 24 months ]
    To identify humoral immune responses generated by the candidate vaccine in patients with persistent PKDL using a gamma interferon ELISpot assay

  3. Clinical changes in PKDL disease [ Time Frame: 24 months ]
    To observe any changes in the appearance of the cutaneous PKDL disease over a 120 day period following vaccination.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969134


Contacts
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Contact: Paul Kaye 01904328845 paul.kaye@york.ac.uk
Contact: Rebecca Wiggins 01904328934 rebecca.wiggins@york.ac.uk

Locations
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Sudan
Institute of Tropical Medicine Recruiting
Doka, Gedarif, Sudan
Contact: Ahmed M Musa, MD    00249918043288    amusa@iend.org   
Contact: Brima Y Musa, MD    00249920005736    brimamusa@hotmail.com   
Sponsors and Collaborators
University of York
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Responsible Party: Paul Kaye, Project Lead, University of York
ClinicalTrials.gov Identifier: NCT03969134    
Other Study ID Numbers: LEISH2b
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases