Leishmaniasis, Cutaneous Clinical Trial
Official title:
A Phase IIa Safety Study to Assess the Safety and Immunogenicity of a New Leishmania Vaccine Candidate ChAd63-KH
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.
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.
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