NCT02894008

A Study of a New Leishmania Vaccine Candidate ChAd63-KH

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of York · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Leishmaniasis, Cutaneous

Interventions

Type	Name	Description
DRUG	ChAd63-KH	ChAd63-KH in adults and adolescents with persistent PKDL.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-09-30
• Completion: 2019-12-31
• First posted: 2016-09-09
• Last updated: 2020-01-28

Locations

1 site across 1 country: Sudan