Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02894008
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2016-08-01
Brief Title:
A Study of a New Leishmania Vaccine Candidate ChAd63-KH
Sponsor:
University of York
Organization:
University of York
Study Overview
Official Title:
A Phase IIa Safety Study to Assess the Safety and Immunogenicity of a New Leishmania Vaccine Candidate ChAd63-KH
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Leish2a
Brief 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 1x1010vp and the subsequent eight volunteers will receive 75 x1010vp Adolescents will be vaccinated with either 1x1010vp or 75 x1010vp to be determined by evaluation of all available data after DSMB CTSC review
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 1x1010vp and the subsequent eight volunteers will receive 75 x1010vp Adolescents will be vaccinated with either 1x1010vp or 75 x1010vp 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 40000 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 eg 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 1x1010vp and following DSMB and CTSC review the subsequent eights adult volunteers will receive 75 x1010vp Doses will be administered at a single time point Adolescents will be vaccinated with either 1x1010vp or 75 x1010vp 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
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 eg 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 1x1010vp and following DSMB and CTSC review the subsequent eights adult volunteers will receive 75 x1010vp Doses will be administered at a single time point Adolescents will be vaccinated with either 1x1010vp or 75 x1010vp 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None