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Effects of BCG vaccination on bone marrow cells.


- candidate number25654
- NTR NumberNTR6501
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-dec-2016
- Secondary IDsNL55825.091.15  2015-2177
- Public TitleEffects of BCG vaccination on bone marrow cells.
- Scientific TitleEFFECTS OF BCG VACCINATION ON IMMUNOLOGICAL CHARACTERISTICS OF HEMATOPOETIC STEM CELLS: an explorative study
- ACRONYMBCG-BM1
- hypothesisWe hypothesize that BCG vaccination leads to alterations in the composition and function of the bone marrow, leading to the observed long-term immunolomodulatory effects of BCG on the innate immune system.
- Healt Condition(s) or Problem(s) studiedVaccination, Bone marrow cells, Innate immunity
- Inclusion criteria- Written informed consent
- Age 18
- Healthy
- Exclusion criteria- Use of systemic medication other than oral anti-contraceptive drugs
- Vaccination within 3 months prior to study period
- History of haematological disease
- History of malignancy
- Medical history of disease associated with immune deficiency
- Previous BCG vaccination
- Acute illness within 2 months prior to start of study
- Pregnancy
- Anaemia or other deviations in a complete blood count
- NSAID within the last 2 weeks
- History of claustrophobia
- Fastened glucose > 8 mmol/l
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 19-jan-2017
- planned closingdate1-jun-2017
- Target number of participants20
- InterventionsBCG vaccination
- Primary outcome- Cellular composition of bone marrow compartment by FACS
- Ex-vivo cytokine (IL-1, TNF, IL-6, IL-10, IFN) release of full bone marrow aspirate, PBMCs, CD34+ cell fraction and bone marrow derived macrophages upon stimulation with PAMPs (e.g. LPS) and pathogens (e.g. S. aureus, C. albicans, M. tuberculosis, S. pneumonia)
Secondary study parameters
- Secondary outcome- Glycolytic activity of bone marrow, spleen and lymph nodes by use of FDG-PET by measuring standardized uptake values in predesignated volumes of interest.
- Functional assessment of PBMC function
- Hematopoietic lineage differentiation
- Gene expression of HSPCs and peripheral blood monocytes
- Epigenetic changes in HSPCs and peripheral blood monocytes
- Cellular metabolism of HSPCs and peripheral blood monocytes
- SNP analysis for SNPs known to influence innate immune function will be analysed and correlated with induction of trained immunity in PBMCs and HSPCs
- TimepointsBaseline (T0)
Two weeks (Tw2)
Three months (Tm3)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L.C.J. de Bree
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- Publications
- Brief summaryBCG vaccination is associated with non specific beneficial effects, leading to decreased childhood mortality in countries with high infectious disease burden. A possible immunological mechanism causing these non specific effects is BCG induced trained immunity. BCG vaccination leads to epigenetic modifications in innate immune cells, resulting in an enhenced cytokine respons after restimulation with a non-specific pathogen.
These effects last for up to one year. A hypothesis explaining the longevity of these effects is that BCG could induce alterations in hematopoeitic stem and progenitor cells.
- Main changes (audit trail)
- RECORD12-dec-2016 - 10-jul-2017


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