ArticlePLoS neglected tropical diseases2017
A third generation vaccine for human visceral leishmaniasis and post kala azar dermal leishmaniasis: First-in-human trial of ChAd63-KH.
Article in PLoS neglected tropical diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers, 1 of them a synthesis that pooled it.
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Who cites it
79 citing papers in PubMed, 1 synthesis or guideline pooled it, 156 citations in OpenAlex.
- Differentially modulated proteins associated with Leishmaniasis-a systematic review of in-vivo and in-vitro studies.Molecular biology reports · 2020Pooled it
- Safety and immunogenicity of ChAd63-KH vaccine in post-kala-azar dermal leishmaniasis patients in Sudan.Molecular therapy : the journal of the American Society of Gene Therapy · 2021Trial
- A Novel Vaccine Strategy Employing Serologically Different Chimpanzee Adenoviral Vectors for the Prevention of HIV-1 and HCV Coinfection.Frontiers in immunology · 2018Trial
- Lymphocyte-mediated immune responses to Leishmania infection.Nature reviews. Immunology · 2026Review
- Leish-F1 Multi-epitope Lentiviral Vaccine as a Novel Candidate Against Leishmania major in Balb/c Mice.Biochemical genetics · 2026Article
- Accelerating vaccine research and development for skin neglected tropical diseases: A case for leishmaniasis, leprosy, and Buruli ulcer.PLoS neglected tropical diseases · 2026Review
- Next-Generation Vaccines Against Neglected Diseases: New Promises from Genetically Modified Live-Attenuated Parasites and RNA Vaccines.Microorganisms · 2026Review
- Epitope prediction and immunogenicity assessment of Leishmania donovani TryS protein as a potential vaccine candidate.Immunologic research · 2026Article
- GenIV vaccines: bridging innovation to equity in neglected tropical diseases.Frontiers in immunology · 2026Review
- Genetic Manipulation Tools in Leishmania: From CRISPR/Cas9 to Vaccine Strategies for Disease Control.Acta parasitologica · 2025Review
- Large-scale randomized double-blind field clinical trial for safety and efficacy assessment of the DNA vaccine Neoleish against canine leishmaniasis.PLoS neglected tropical diseases · 2025Article
- Expression and immunogenicity evaluation of a novel Lentiviral multi- epitope vaccine against Leishmania major in BALB/c mice.Tropical diseases, travel medicine and vaccines · 2025Article
- Commentary on the Issue ofVeterinary sciences · 2025Article
- LmCenNPJ vaccines · 2025Article
- Vaccines in Dermatology-Present and Future: A Review.Vaccines · 2025Review
- Molecular and Immunological Properties of a Chimeric Glycosyl Hydrolase 18 Based on Immunoinformatics Approaches: A Design of a New Anti-ACS pharmacology & translational science · 2025Article
- Advances inPathogens (Basel, Switzerland) · 2024Review
- A randomized, double-blind phase 2b trial to evaluate efficacy of ChAd63-KH for treatment of post kala-azar dermal leishmaniasis.Molecular therapy. Methods & clinical development · 2024Article
- An update on recombinant vaccines against leishmaniasis.The Indian journal of medical research · 2024Review
- Exploring malaria parasite surface proteins to devise highly immunogenic multi-epitope subunit vaccine for Plasmodium falciparum.Journal, genetic engineering & biotechnology · 2024Article
19 more citing papers are in PubMed but not listed here.
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Authors and funding
15 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVisceral leishmaniasis (VL or kala azar) is the most serious form of human leishmaniasis, responsible for over 20,000 deaths annually, and post kala azar dermal leishmaniasis (PKDL) is a stigmatizing skin condition that often occurs in patients after successful treatment for VL. Lack of effective or appropriately targeted cell mediated immunity, including CD8+ T cell responses, underlies the progression of VL and progression to PKDL, and can limit the therapeutic efficacy of anti-leishmanial drugs. Hence, in addition to the need for prophylactic vaccines against leishmaniasis, the development of therapeutic vaccines for use alone or in combined immuno-chemotherapy has been identified as an unmet clinical need. Here, we report the first clinical trial of a third-generation leishmaniasis vaccine, developed intentionally to induce Leishmania-specific CD8+ T cells.
methodsWe conducted a first-in-human dose escalation Phase I trial in 20 healthy volunteers to assess the safety, tolerability and immunogenicity of a prime-only adenoviral vaccine for human VL and PKDL. ChAd63-KH is a replication defective simian adenovirus expressing a novel synthetic gene (KH) encoding two Leishmania proteins KMP-11 and HASPB. Uniquely, the latter was engineered to reflect repeat domain polymorphisms and arrangements identified from clinical isolates. We monitored innate immune responses by whole blood RNA-Seq and antigen specific CD8+ T cell responses by IFNγ ELISPOT and intracellular flow cytometry.
findingsChAd63-KH was safe at intramuscular doses of 1x1010 and 7.5x1010 vp. Whole blood transcriptomic profiling indicated that ChAd63-KH induced innate immune responses characterized by an interferon signature and the presence of activated dendritic cells. Broad and quantitatively robust CD8+ T cell responses were induced by vaccination in 100% (20/20) of vaccinated subjects.
conclusionThe results of this study support the further development of ChAd63-KH as a novel third generation vaccine for VL and PKDL.
trial registrationThis clinical trial (LEISH1) was registered at EudraCT (2012-005596-14) and ISRCTN (07766359).
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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.