A Study of a New Leishmania Vaccine Candidate ChAd63-KH

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02894008
• Date of registration: 01/08/2016
• Prospective Registration: Yes
• Primary sponsor: University of York
• Public title: A Study of a New Leishmania Vaccine Candidate ChAd63-KH Leish2a
• Scientific title: A Phase IIa Safety Study to Assess the Safety and Immunogenicity of a New Leishmania Vaccine Candidate ChAd63-KH
• Date of first enrolment: November 2016
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02894008
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Sudan

Contacts

• Name: Ahmed Musa, MBBS
• Affiliation: University of Khartoum

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- 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.

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

- 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

- 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



Age minimum: 12 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Leishmaniasis, Cutaneous

Intervention(s)

Drug: ChAd63-KH

Primary Outcome(s)

Safety [Time Frame: 90 days]

Secondary Outcome(s)

Clinical changes in cutaneous PKDL disease [Time Frame: 42 days following vaccination]

Cellular immune responses [Time Frame: 90 days]

Secondary ID(s)

2016-000369-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Khartoum