A Study of a New Leishmania Vaccine Candidate ChAd63-KH

NCT02894008 | Completed Phase 2 DMC

• 1 other identifier: 2016-000369-22
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Leishmaniasis, Cutaneous

Outcome Measures

Primary Outcomes (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)

  90 days

Secondary Outcomes (2)

• Cellular immune responses

  90 days

• Clinical changes in cutaneous PKDL disease

  42 days following vaccination

Study Arms (2)

ChAd63- KH

EXPERIMENTAL

Single intramuscular dose of ChAd63-KH, 1 x10(10)vp or, following safety review, 7.5 x 10(10)vp in adults

Drug: ChAd63-KH

ChAd63-KH

EXPERIMENTAL

Single intramuscular dose of ChAd63-KH, 1x10(10)vp or, following safety review, 7.5 x 10(10)vp in adolescents

Drug: ChAd63-KH

Interventions

ChAd63-KH DRUG

ChAd63-KH in adults and adolescents with persistent PKDL.

ChAd63- KH; ChAd63-KH

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of York: lead
• University of Khartoum: collaborator

Study Sites (1)

Centre for Tropical Medicine

Doka, Gedarif, Sudan

Location

Related Publications (1)

• 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.

  PMID: 33781913 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ahmed Musa, MBBS

  University of Khartoum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Paul Kaye

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: September 9, 2016
• Study Start: November 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

SU (1)