Evidence map›Paper›PMID 25883989›Full record

Trial reportJournal of immunology research2015

Gamma-irradiated bacille Calmette-Guérin vaccination does not modulate the innate immune response during experimental human endotoxemia in adult males.

Linda A C Hamers, Matthijs Kox, Rob J W Arts, Bastiaan Blok, Jenneke Leentjens, Mihai G Netea, Peter Pickkers

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of immunology research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02085590 (The Effects of BCG-vaccination on the Innate Immune Response in Healthy Volunteers. Pilot Proof-of-principle Studie), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 28% 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.

NCT02085590 phase2 / phase3completednot on this map

The Effects of BCG-vaccination on the Innate Immune Response in Healthy Volunteers. Pilot Proof-of-principle Studie

TypeinterventionalSponsorRadboud University Medical CenterRan2014 to 2014Enrolled20ConditionsSepsisArmsBCG vaccine, Lipopolysaccharide (LPS) E. Coli 1 ng/kg intravenously
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. 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

7 authors at 2 institutions in 1 country.

Linda A C HamersDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), P.O. Box 9101, 6500 HB Nijmegen, Netherlands ; Department of Internal Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), P.O. Box 9101, 6500 HB Nijmegen, Netherlands.
Matthijs KoxDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), P.O. Box 9101, 6500 HB Nijmegen, Netherlands.
Rob J W ArtsDepartment of Internal Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), P.O. Box 9101, 6500 HB Nijmegen, Netherlands.
Bastiaan BlokDepartment of Internal Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), P.O. Box 9101, 6500 HB Nijmegen, Netherlands.
Jenneke LeentjensDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), P.O. Box 9101, 6500 HB Nijmegen, Netherlands ; Department of Internal Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), P.O. Box 9101, 6500 HB Nijmegen, Netherlands.
Mihai G NeteaDepartment of Internal Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), P.O. Box 9101, 6500 HB Nijmegen, Netherlands.
Peter PickkersDepartment of Intensive Care Medicine, Radboud University Medical Center, Radboud Center for Infectious Diseases (RCI), P.O. Box 9101, 6500 HB Nijmegen, Netherlands.
Radboud University Nijmegen · NLRadboud University Medical Center · NL

Funding

European Research Council 310372
6 · The paper itself

Abstract

Bacille Calmette-Guérin (BCG) vaccine exerts nonspecific immunostimulatory effects and may therefore represent a novel therapeutic option to treat sepsis-induced immunoparalysis. We investigated whether BCG vaccination modulates the systemic innate immune response in humans in vivo during experimental endotoxemia. We used inactivated gamma-irradiated BCG vaccine because of the potential risk of disseminated disease with the live vaccine in immunoparalyzed patients. In a randomized double-blind placebo-controlled study, healthy male volunteers were vaccinated with gamma-irradiated BCG (n = 10) or placebo (n = 10) and received 1 ng/kg lipopolysaccharide (LPS) intravenously on day 5 after vaccination to assess the in vivo immune response. Peripheral blood mononuclear cells were stimulated with various related and unrelated pathogens 5, 8 to 10, and 25 to 35 days after vaccination to assess ex vivo immune responses. BCG vaccination resulted in a scar in 90% of vaccinated subjects. LPS administration elicited a profound systemic immune response, characterized by increased levels of pro- and anti-inflammatory cytokines, hemodynamic changes, and flu-like symptoms. However, BCG modulated neither this in vivo immune response, nor ex vivo leukocyte responses at any time point. In conclusion, gamma-irradiated BCG is unlikely to represent an effective treatment option to restore immunocompetence in patients with sepsis-induced immunoparalysis. This trial is registered with NCT02085590.

Indexed as

AdultBCG VaccineCytokinesDouble-Blind MethodEndotoxemiaHumansImmunity, InnateLeukocytes, MononuclearLipopolysaccharidesLymphocyte ActivationMaleMycobacterium bovisPlacebosVaccinationBCG VaccineCytokinesLipopolysaccharidesPlacebos

Identifiers

PMID25883989
PMCPMC4391613
OpenAlexW2057312263

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.