A Study of a New Leishmania Vaccine Candidate ChAd63-KH
Status:
Completed
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
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.