Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02894008
Study type Interventional
Source University of York
Contact Paul M Kaye, PhD, FRCPath
Phone +44 1904 328845
Email paul.kaye@york.ac.uk
Status Recruiting
Phase Phase 2
Start date November 2016
Completion date December 2018

See also
  Status Clinical Trial Phase
Completed NCT00111553 - Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis Phase 1
Not yet recruiting NCT03303898 - ASYMPTOMATIC CARRIER OF LEISHMANIA INFANTUM, MEDISERRANEAN VISCERAL LEISHMANIOSIS AGENT: STUDY OF IMMUNE RESPONSE - POSTULATE PRIOR TO HUMAN VACCINAL TRIALS Immune Response of Asymptomatic Carriers to L. Infantum N/A
Completed NCT01083576 - Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama Phase 2
Terminated NCT01140191 - Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis Phase 2
Completed NCT03445897 - Miltefosine Plus IL Pentamidine for Bolivian CL Phase 2
Completed NCT01032382 - Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK) Phase 2
Completed NCT00480883 - Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol N/A
Completed NCT00469495 - Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis N/A
Completed NCT03294161 - Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis Phase 2
Recruiting NCT03096457 - Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia Phase 2/Phase 3
Available NCT00508963 - Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis N/A
Available NCT01641796 - Paromomycin for Individuals With Uncomplicated Cutaneous Leishmaniasis N/A