A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03969134|
Recruitment Status : Active, not recruiting
First Posted : May 31, 2019
Last Update Posted : September 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Leishmaniasis, Cutaneous||Biological: ChAd63-KH Other: Placebo||Phase 2|
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:
- To compare the humoral and cellular immune responses generated by the candidate vaccine in patients with persistent PKDL.
- To observe any clinical changes in the cutaneous PKDL disease over a 120 day period following vaccination
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised, double blinded, placebo controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Fifty volunteers receive a single intramuscular dose of ChAd63 KH 7.5x1010vp and 50 placebo. Investigators and the participant will be blinded. A pharmacist and nurse will prepare the injections. There will be stratification between patients aged 12-17, and patients aged 18-50, to ensure balanced randomisation. The pharmacist will be told which age strata the patient is in by a nurse, and will prepare the injection with the study nurse. There will be two series of sealed envelopes, one for each of the adolescent and adult cohorts. These envelopes will have external labelling, with the cohort, and successive cohort patient numbering. Each envelope contains randomisation to VACCINE or SALINE. The vaccine and placebo injections will be prepared in blacked-out syringes labelled with patient cohort number. The study nurse will take the prepared injection to the clinical team for administration. The syringe will be further labelled with the patient's initials, date and time of injection.|
|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|
|Actual Study Start Date :||April 6, 2020|
|Actual Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||February 28, 2023|
Active Comparator: Vaccine arm
ChAd63 KH 7.5x1010 vp, single dose, by IM injection
The vaccine will be injected intramuscularly into the arm.
Placebo Comparator: Placebo
Normal Saline, single dose, by IM injection
The placebo will be injected intramuscularly into the arm.
- To assess the number of participants with treatment-related adverse events as defined in the clinical trial protocol V1.0. [ Time Frame: 24 months ]To assess the number of participants with treatment-related adverse events as defined in the clinical trial protocol V1.0.
- To assess the therapeutic efficacy of CHAd63-KH, a new candidate, in patients with PKDL by clinical judgement of PKDL lesion reduction. [ Time Frame: 24 months ]To assess the therapeutic efficacy of CHAd63-KH, a new candidate, in patients with PKDL by clinical judgement of PKDL lesion reduction.
- Immune responses by presence of interferon gamma producing T cells [ Time Frame: 24 months ]To identify cellular immune responses generated by the candidate vaccine in patients with persistent PKDL using a gamma interferon ELISpot assay
- Immune responses by presence of serum antibodies against Leishmania peptides [ Time Frame: 24 months ]To identify humoral immune responses generated by the candidate vaccine in patients with persistent PKDL using a gamma interferon ELISpot assay
- Clinical changes in PKDL disease [ Time Frame: 24 months ]To observe any changes in the appearance of the cutaneous PKDL disease over a 120 day period following vaccination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969134
|Institute of Tropical Medicine|
|Doka, Gedarif, Sudan|