Evidence map›Paper›PMID 25871827›Full record

ArticleGene therapy2015

Preclinical safety and tolerability of a repeatedly administered human leishmaniasis DNA vaccine.

O Riede, K Seifert, D Oswald, A Endmann, C Hock, A Winkler, F J Salguero, M Schroff, S L Croft, C Juhls

Abstract read
In one paragraph

Article in Gene therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Preclinical and Clinical Demonstration of Immunogenicity by mRNA Vaccines against H10N8 and H7N9 Influenza Viruses.Molecular therapy : the journal of the American Society of Gene Therapy · 2017
    Trial
  2. Research Progress on Liposome Pulmonary Delivery ofJournal of aerosol medicine and pulmonary drug delivery · 2024
    Review
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  4. Article
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  7. Review
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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

10 authors.

O RiedeMOLOGEN AG, Berlin, Germany.
K SeifertFaculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
D OswaldMOLOGEN AG, Berlin, Germany.
A EndmannMOLOGEN AG, Berlin, Germany.
C HockIMGM Laboratories GmbH, Martinsried, Germany.
A WinklerLPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Hamburg, Germany.
F J SalgueroAnimal Health and Veterinary Laboratories Agency, New Haw, Addlestone, UK.
M SchroffMOLOGEN AG, Berlin, Germany.
S L CroftFaculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
C JuhlsMOLOGEN AG, Berlin, Germany.ORCID 0000000313574065

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The leishmaniases are a complex of vector-borne diseases caused by protozoan parasites of the genus Leishmania. LEISHDNAVAX is a multi-antigen, T-cell epitope-enriched DNA vaccine candidate against human leishmaniasis. The vaccine candidate has been proven immunogenic and showed prophylactic efficacy in preclinical studies. Here, we describe the safety testing of LEISHDNAVAX in naive mice and rats, complemented by the demonstration of tolerability in Leishmania-infected mice. Biodistribution and persistence were examined following single and repeated intradermal (i.d.) administration to rats. DNA vectors were distributed systemically but did not accumulate upon repeated injections. Although vector DNA was cleared from most other tissues within 60 days after the last injection, it persisted in skin at the site of injection and in draining lymph nodes. Evaluation of single-dose and repeated-dose toxicity of the vaccine candidate after i.d. administration to naive, non-infected mice did not reveal any safety concerns. LEISHDNAVAX was also well tolerated in Leishmania-infected mice. Taken together, our results substantiate a favorable safety profile of LEISHDNAVAX in both naive and infected animals and thus, support the initiation of clinical trials for both preventive and therapeutic applications of the vaccine.

Indexed as

AnimalsDisease Models, AnimalDrug Evaluation, PreclinicalGenetic VectorsLeishmaniasisMice, Inbred BALB CRats, WistarVaccines, DNAVaccines, DNA

Identifiers

PMID25871827
PMCPMC4530203

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Registered trials

None linked

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.