Evidence map›Paper›PMID 39253357›Full record

ArticleMolecular therapy. Methods & clinical development2024

A randomized, double-blind phase 2b trial to evaluate efficacy of ChAd63-KH for treatment of post kala-azar dermal leishmaniasis.

Brima M Younis, Rebecca Wiggins, Eltahir A G Khalil, Mohamed Osman, Francesco Santoro, Chiara Sonnati, Ada Keding, Maria Novedrati, Giorgio Montesi, Ali Noureldein and 11 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Molecular therapy. Methods & clinical development, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03969134 (A Phase IIb Study to Assess the Safety, Efficacy and Immunogenicity of the Leishmania Vaccine ChAd63-KH in Post-kala Azar Dermal Leishmaniasis), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03969134 phase2completednot on this map

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

TypeinterventionalSponsorUniversity of YorkRan2020 to 2023Enrolled86ConditionsLeishmaniasis, CutaneousArmsChAd63-KH, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Leishmaniasis.Nature reviews. Disease primers · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Brima M YounisDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.
Rebecca WigginsYork Biomedical Research Institute, Hull York Medical School, University of York, Heslington, York YO10 5DD, UK.
Eltahir A G KhalilDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.
Mohamed OsmanYork Biomedical Research Institute, Hull York Medical School, University of York, Heslington, York YO10 5DD, UK.
Francesco SantoroDepartment of Medical Biotechnologies, University of Siena, 53100 Siena, Italy.
Chiara SonnatiDepartment of Medical Biotechnologies, University of Siena, 53100 Siena, Italy.
Ada KedingDepartment of Health Sciences, University of York, Heslington, York YO10 5DD, UK.
Maria NovedratiDepartment of Medical Biotechnologies, University of Siena, 53100 Siena, Italy.
Giorgio MontesiDepartment of Medical Biotechnologies, University of Siena, 53100 Siena, Italy.
Ali NoureldeinDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.
Elmukashfi T A ElmukashfiDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.
Ala Eldin MustafaDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.
Mohammed AlaminDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.
Mohammed SaeedDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.
Khalid SalmanDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.
Ahmed J SulimanDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.
Amin E A MusaDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.
Alison M LaytonYork Biomedical Research Institute, Hull York Medical School, University of York, Heslington, York YO10 5DD, UK.
Charles J N LaceyYork Biomedical Research Institute, Hull York Medical School, University of York, Heslington, York YO10 5DD, UK.
Paul M KayeYork Biomedical Research Institute, Hull York Medical School, University of York, Heslington, York YO10 5DD, UK.
Ahmed M MusaDepartment of Clinical Pathology & Immunology, Institute of Endemic Diseases, University of Khartoum, Khartoum 11111, Sudan.

Funding

Wellcome Trust
6 · The paper itself

Abstract

In a recent phase 2a clinical trial, the candidate leishmaniasis vaccine ChAd63-KH was shown to be safe and immunogenic in Sudanese patients with post kala-azar dermal leishmaniasis (PKDL). However, its value as a stand-alone therapeutic was unknown. To assess the therapeutic efficacy of ChAd63-KH, we conducted a randomized, double-blind, placebo-controlled phase 2b trial (ClinicalTrials.gov: NCT03969134). Primary outcomes were safety and efficacy (≥90% improvement in clinical disease). Secondary outcomes were change in severity grade and vaccine-induced immune response. 86 participants with uncomplicated PKDL of ≥6 month duration were randomized to receive ChAd63-KH (7.5 × 10

Indexed as

adenovirusclinical trialLeishmaniapost kala-azar dermal leishmaniasistherapeuticvaccine

Identifiers

PMID39253357
PMCPMC11381778

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.