Clinical Trials Logo
  1. Home
  2. Leishmaniasis, Cutaneous
  3. NCT03969134

A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL

Leishmaniasis, Cutaneous Clinical Trial

Official title:
A Phase IIb Study to Assess the Safety, Efficacy and Immunogenicity of the Leishmania Vaccine ChAd63-KH in Post-kala Azar Dermal Leishmaniasis

Clinical Trial Summary

This trial is designed to assess the therapeutic efficacy and safety of CHAd63-KH, a new candidate Leishmania vaccine, in patients with persistent PKDL. 100 participants will be randomly assigned (50 participants in each arm) to receive placebo or ChAd63-KH 7.5 x10(10)vp. Doses will be administered at a single time point.

Clinical Trial Description

This study is a randomised, double blinded, placebo controlled trial designed to assess the therapeutic efficacy and safety of CHAd63-KH, a new candidate Leishmania vaccine, in patients with persistent PKDL. 100 participants will be randomly assigned (50 participants in each arm) to receive placebo or ChAd63-KH 7.5 x10(10)vp intramuscular injection into the deltoid region. Doses will be administered at a single time point. Volunteers aged between 12-50 years with persistent PKDL will be recruited at Professor El-Hassan's Centre for Tropical Medicine, Dooka, Gedarif State, Sudan, and will be followed up for 120 days after the dosing visit. The trial is planned to run for 24 months. Secondary objectives are as follows: 1. To compare the humoral and cellular immune responses generated by the candidate vaccine in patients with persistent PKDL. 2. To observe any clinical changes in the cutaneous PKDL disease over a 120 day period following vaccination ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03969134
Study type Interventional
Source University of York
Contact
Status Completed
Phase Phase 2
Start date April 6, 2020
Completion date February 28, 2023
View Details
See also
  Status Clinical Trial Phase
Terminated NCT01140191 - Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis Phase 2
Completed NCT03999970 - A Clinical Study to Develop an Uninfected Sand Fly Biting Protocol N/A
Completed NCT00111553 - Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis Phase 1
Recruiting NCT03762070 - Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru
Completed NCT02894008 - A Study of a New Leishmania Vaccine Candidate ChAd63-KH Phase 2
Completed NCT03303898 - ASYMPTOMATIC CARRIER OF LEISHMANIA INFANTUM, MEDISERRANEAN VISCERAL LEISHMANIOSIS AGENT: STUDY OF IMMUNE RESPONSE - N/A
Recruiting NCT05094908 - Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis Phase 1
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
Completed NCT03445897 - Miltefosine Plus IL Pentamidine for Bolivian CL Phase 2
Withdrawn NCT04072874 - Evaluation of the Safety and Clinical Activity of Curaleish in the Topical Treatment of Cutaneous Leishmaniasis. Phase 1/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
Recruiting NCT05708625 - Intralesional Voriconazole, or Intralesional Cryotherapy, or Oral Doxycycline in the Treatment of Cutaneous Leishmaniasis Phase 3
Completed NCT04841239 - Development of Topical Herbal Formulations for Treatment of Cutaneous Leishmaniasis 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
Completed NCT04888130 - Investigation of an Outbreak Situation of Cutaneous Leishmaniasis Among Military Personnel in French Guiana (CEFELEISH)
Completed NCT03096457 - Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia Phase 2/Phase 3
No longer available NCT01641796 - Paromomycin for Individuals With Uncomplicated Cutaneous Leishmaniasis
No longer available NCT00508963 - Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis