Evidence map›Paper›PMID 41997829›Full record

ArticleEBioMedicine2026

An observational study to test the potency of GLP-grade phenol-free lyophilised leishmanin antigen formulation.

Thalia Pacheco-Fernandez, Laura Klenow, Shin-Ichi Inoue, Kamaleshwar P Singh, Farzaneh Valanezhad, Hannah Markle, Nazli Azodi, Meghan Brino, Shara Bakytbek, Caroline Hobson and 18 more

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Article in EBioMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

28 authors.

Thalia Pacheco-FernandezDivision of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Silver Spring, MD, USA.
Laura KlenowDivision of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Silver Spring, MD, USA.
Shin-Ichi InoueDepartment of Immunology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Kamaleshwar P SinghGennova Biopharmaceuticals, Hinjawadi Phase II, Pune, Maharashtra, India.
Farzaneh ValanezhadDepartment of Parasitology, the Joint Usage/Research Center on Tropical Disease, Institute of Tropical Medicine (NEKKEN), and Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Hannah MarkleDivision of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Silver Spring, MD, USA.
Nazli AzodiDivision of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Silver Spring, MD, USA.
Meghan BrinoDivision of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Silver Spring, MD, USA.
Shara BakytbekDepartment of Parasitology, the Joint Usage/Research Center on Tropical Disease, Institute of Tropical Medicine (NEKKEN), and Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Caroline HobsonDivision of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Silver Spring, MD, USA.
Ishaan JainDivision of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Silver Spring, MD, USA.
Pratik TalgaonkarGennova Biopharmaceuticals, Hinjawadi Phase II, Pune, Maharashtra, India.
Shalu ShuklaGennova Biopharmaceuticals, Hinjawadi Phase II, Pune, Maharashtra, India.
Pawan KardileGennova Biopharmaceuticals, Hinjawadi Phase II, Pune, Maharashtra, India.
Swarnendu KavirajGennova Biopharmaceuticals, Hinjawadi Phase II, Pune, Maharashtra, India.
Larissa O SilvaInstituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil.
Pedro B BorbaInstituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil.
Marina SantanaInstituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil.
Taylla CostaInstituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil.
Greg MatlashewskiDepartment of Microbiology and Immunology, McGill University, Montreal, QC, Canada.
Lucas P CarvalhoInstituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil; Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais (INCT-DT), Salvador, Bahia, Brazil.
Edgar M CarvalhoInstituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil; Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais (INCT-DT), Salvador, Bahia, Brazil.
Camila I de OliveiraInstituto Gonçalo Muniz, FIOCRUZ, Salvador, BA, Brazil; Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais (INCT-DT), Salvador, Bahia, Brazil.
Abhay R SatoskarDepartment of Pathology and Microbiology, Ohio State University, Columbus, OH, USA. Electronic address: Abhay.satoskar@osumc.edu.
Sanjay SinghGennova Biopharmaceuticals, Hinjawadi Phase II, Pune, Maharashtra, India. Electronic address: sanjay.singh@gennova.co.in.
Shinjiro HamanoDepartment of Parasitology, the Joint Usage/Research Center on Tropical Disease, Institute of Tropical Medicine (NEKKEN), and Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan. Electronic address: shinjiro@nagasaki-u.ac.jp.
Sreenivas GannavaramDivision of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Silver Spring, MD, USA. Electronic address: Sreenivas.gannavaram@fda.hhs.gov.
Hira L NakhasiDivision of Emerging and Transfusion Transmitted Diseases, CBER, FDA, Silver Spring, MD, USA. Electronic address: hira.nakhasi@fda.hhs.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeishmaniasis is a vector-borne disease transmitted through sand fly vectors carrying protozoan parasites from the genus Leishmania. The leishmanin skin test (LST), used to detect exposure to Leishmania parasites, is no longer available due to a lack of well-characterised antigens. Towards reintroducing the LST, we previously developed a preparation of the leishmanin antigens using a freeze-thaw (FT) process, which induced a delayed-type hypersensitivity (DTH) response in hosts exposed to Leishmania parasites. The storage of FT preparation antigens requires refrigeration, which is not practical for use in field settings.

methodsWe developed a safe, simple and scalable antigen extraction process and a phenol-free lyophilised-LST antigen formulation that obviates the need for a cold-chain under Good Laboratory Practice conditions (GLP-LST

findingsThe GLP-LST

interpretationThese results demonstrated the potency of our formulation in IGRA studies, which could aid immunogenicity studies in vaccine trials, and surveillance studies in both endemic and emerging areas of Leishmania infection.

fundingThese studies are supported by funding from GHIT Fund, Japan, CIHR, Canada, intramural funding from the FDA, and FIOCRUZ and INCT-DT Brazil.

Indexed as

Antigens, ProtozoanLeishmania majorLeishmaniasisLeishmaniasis, CutaneousLeishmaniasis VaccinesAnimalsDisease Models, AnimalFemaleFreeze DryingHumansHypersensitivity, DelayedLeishmaniaMiceAntigens, ProtozoanLeishmaniasis VaccinesleishmaninDTH responseIGRALeishmaniasisLeishmanin skin testVaccine

Identifiers

PMID41997829
PMCPMC13174243

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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.