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A Study of a New Leishmania Vaccine Candidate ChAd63-KH

NCT02894008 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-01-28

No results posted yet for this study

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

Interventions

DRUG

ChAd63-KH

ChAd63-KH in adults and adolescents with persistent PKDL.

Sponsors & Collaborators

  • University of Khartoum

    collaborator OTHER

  • University of York

    lead OTHER

Principal Investigators

  • Ahmed Musa, MBBS · University of Khartoum

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-09-30
Completion
2019-12-31

Countries

  • Sudan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02894008 on ClinicalTrials.gov