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γ-irradiated BCG to Train Innate Immunity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02259608
Recruitment Status : Completed
First Posted : October 8, 2014
Results First Posted : June 29, 2016
Last Update Posted : June 29, 2016
Information provided by (Responsible Party):
Radboud University

Brief Summary:

Rationale: The live attenuated Bacillus Calmette-Guerin (BCG) vaccine protects against extrapulmonary infection with Mycobacterium tuberculosis and leprosy. It has been shown that vaccination with BCG also leads to nonspecific protective effects, e.g. reduced infant mortality as a result of less severe infections, stimulation of the immune system in patients with bladder cancer and higher cytokine production upon restimulation of macrophages with non-related infectious pathogens in vitro. However, because the live attenuated BCG vaccine cannot be used in immune compromised hosts, the investigators would like to determine whether similar protective non-specific effects can be induced by γ-irradiated BCG.

Objective: To determine whether vaccination with γ-irradiated BCG results in a higher cytokine response by monocytes upon restimulation in vitro with infectious pathogens, compared to monocytes before the vaccination.

Study design: Explorative intervention trial. Study population: Healthy volunteers, 18 - 55 years old. Intervention: Healthy volunteers will be vaccinated with γ-irradiated BCG vaccine.

Main study parameters/endpoints: Blood will be drawn before and at two different time points after vaccination with BCG to perform restimulation of isolated cells in vitro and compare cytokine production.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no known direct benefit for the volunteers to participate in the trial. The risks are negligible. BCG vaccination can cause pain and scarring at the site of injection, just as fever and headache. Local hematoma formation can occur at the site of the blood drawing. This will be minimized by the blood collection by experienced persons.

Condition or disease Intervention/treatment Phase
Innate Immune Response Biological: BCG vaccine SSI Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Training of Innate Immunity by Vaccination With γ-irradiated BCG
Study Start Date : November 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BCG vaccine SSI
Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.
Biological: BCG vaccine SSI
BCG vaccination
Other Name: J07AN01

Primary Outcome Measures :
  1. Cytokine Production Measured by ELISA Compared to Baseline [ Time Frame: 0 weeks and 3 months ]

    Comparing tnfa production of PBMCs after 24h stimulation with candida before and 3 months after yBCG vaccination.

    Baseline is set as 1.

Secondary Outcome Measures :
  1. Cytokine Production Measured by ELISA Compared to Baseline [ Time Frame: 0 weeks and 2 weeks ]
    Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The subjects must be healthy adults, aged 18 - 55 years old

Exclusion Criteria:

  • Subjects are excluded when they are from tuberculosis endemic countries, if they have been in contact with tuberculosis patients or if they have been earlier vaccinated with BCG.
  • The subjects are excluded from the study if they suffer for any disease, including intercurrent infections.
  • Subjects are not allowed to use any medication except oral anticonceptive agents.

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Responsible Party: Radboud University Identifier: NCT02259608     History of Changes
Other Study ID Numbers: NL45427.091.13
2013/319 ( Other Identifier: CMO Arnhem Nijmegen )
First Posted: October 8, 2014    Key Record Dates
Results First Posted: June 29, 2016
Last Update Posted: June 29, 2016
Last Verified: January 2016
Keywords provided by Radboud University:
Trained innate immunity
Heterologous effects of BCG on immunity
Additional relevant MeSH terms:
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BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic