γ-irradiated BCG to Train Innate Immunity

NCT02259608 | Completed Results

• 2 other identifiers: NL45427.091.132013/319
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Innate Immune Response

Keywords

Trained innate immunity; Heterologous effects of BCG on immunity

Outcome Measures

Primary Outcomes (1)

• Cytokine Production Measured by ELISA Compared to Baseline

  Comparing tnfa production of PBMCs after 24h stimulation with candida before and 3 months after yBCG vaccination. Baseline is set as 1.

  0 weeks and 3 months

Secondary Outcomes (1)

• Cytokine Production Measured by ELISA Compared to Baseline

  0 weeks and 2 weeks

Study Arms (1)

BCG vaccine SSI

EXPERIMENTAL

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

Interventions

BCG vaccine SSI BIOLOGICAL

BCG vaccination

Also known as: J07AN01

BCG vaccine SSI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Results Point of Contact

• Title: Rob Arts
• Organization: Radboud UMC

rob.jw.arts@radboudumc.nl

0031 24

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 8, 2014
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 29, 2016
• Results First Posted: June 29, 2016

Record last verified: 2016-01