Evidence map›Paper›PMID 26686385›Full record

Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2016

Development of an Interleukin-1β Vaccine in Patients with Type 2 Diabetes.

Claudia Cavelti-Weder, Katharina Timper, Eleonora Seelig, Cornelia Keller, Martin Osranek, Ute Lässing, Gunther Spohn, Patrik Maurer, Philipp Müller, Gary T Jennings and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00924105 (A Two-Stage Randomized Placebo-controlled Ascending Dose Phase I/ IIa Study to Evaluate Safety, Tolerability, Pharmacodynamic Effects and Preliminary Efficacy of an Anti-Interleukin 1 Beta Vaccine), which is not on this map. Cited by 51 papers.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed
4.9field-weighted citation impact, top 4% of its field
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.

NCT00924105 phase1completednot on this map

A Two-Stage Randomized Placebo-controlled Ascending Dose Phase I/ IIa Study to Evaluate Safety, Tolerability, Pharmacodynamic Effects and Preliminary Efficacy of an Anti-Interleukin 1 Beta Vaccine (CYT013-IL1bQb) in Patients With Type 2 Diabetes Mellitus

TypeinterventionalSponsorCytos Biotechnology AGRan2009 to 2011Enrolled48ConditionsType 2 Diabetes MellitusArmsCYT013-IL1bQb, Placebo
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 73 citations in OpenAlex.

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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

14 authors at 2 institutions in 1 country.

Claudia Cavelti-WederDepartment of Endocrinology, Diabetes, and Metabolism, University Hospital of Basel, Basel, Switzerland.
Katharina TimperDepartment of Endocrinology, Diabetes, and Metabolism, University Hospital of Basel, Basel, Switzerland.
Eleonora SeeligDepartment of Endocrinology, Diabetes, and Metabolism, University Hospital of Basel, Basel, Switzerland.
Cornelia KellerDepartment of Endocrinology, Diabetes, and Metabolism, University Hospital of Zurich, Zurich, Switzerland.
Martin OsranekDepartment of Endocrinology, Diabetes, and Metabolism, University Hospital of Zurich, Zurich, Switzerland.
Ute LässingCytos Biotechnology AG, Schlieren, Switzerland.
Gunther SpohnCytos Biotechnology AG, Schlieren, Switzerland.
Patrik MaurerCytos Biotechnology AG, Schlieren, Switzerland.
Philipp MüllerCytos Biotechnology AG, Schlieren, Switzerland.
Gary T JenningsCytos Biotechnology AG, Schlieren, Switzerland.
Joerg WillersCytos Biotechnology AG, Schlieren, Switzerland.
Philippe SaudanCytos Biotechnology AG, Schlieren, Switzerland.
Marc Y DonathDepartment of Endocrinology, Diabetes, and Metabolism, University Hospital of Basel, Basel, Switzerland.
Martin F BachmannCytos Biotechnology AG, Schlieren, Switzerland.
University Hospital of Basel · CHUniversity Hospital of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Interleukin-1β (IL-1β) is a key cytokine involved in inflammatory illnesses including rare hereditary diseases and common chronic inflammatory conditions as gout, rheumatoid arthritis, and type 2 diabetes mellitus, suggesting reduction of IL-1β activity as new treatment strategy. The objective of our study was to assess safety, antibody response, and preliminary efficacy of a novel vaccine against IL-1β. The vaccine hIL1bQb consisting of full-length, recombinant IL-1β coupled to virus-like particles was tested in a preclinical and clinical, randomized, placebo-controlled, double-blind study in patients with type 2 diabetes. The preclinical simian study showed prompt induction of IL-1β-specific antibodies upon vaccination, while neutralizing antibodies appeared with delay. In the clinical study with 48 type 2 diabetic patients, neutralizing IL-1β-specific antibody responses were detectable after six injections with doses of 900 µg. The development of neutralizing antibodies was associated with higher number of study drug injections, lower baseline body mass index, improvement of glycemia, and C-reactive protein (CRP). The vaccine hIL1bQb was safe and well-tolerated with no differences regarding adverse events between patients receiving hIL1bQb compared to placebo. This is the first description of a vaccine against IL-1β and represents a new treatment option for IL-1β-dependent diseases such as type 2 diabetes mellitus (ClinicalTrials.gov NCT00924105).

Indexed as

AdultAgedAnimalsAntibodies, MonoclonalAntibodies, NeutralizingDiabetes Mellitus, Type 2Double-Blind MethodFemaleHumansInterleukin-1betaMacaca mulattaMaleMiddle AgedTreatment OutcomeVaccinesAntibodies, MonoclonalAntibodies, NeutralizingInterleukin-1betaVaccines

Identifiers

PMID26686385
PMCPMC4881764
OpenAlexW2211852774

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.