To examine the effect of BCG vaccination on the composition and function of the bone marrow.
ID
Source
Brief title
Condition
- Immune disorders NEC
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cellular composition of the bone marrow
Ex vivo differentiation of hematopoetic stem and progenitor cells
Ex vivo cytokine responses of hematopoetic stem and progenitor cells
Secondary outcome
Ex vivo cytokine production of PBMCs and monocytes
Gene expression profiles of hematopoetic stem cells and peripheral monocytes
Epigenetic profiles relating to immune function of hematopoetic stem cells and
peripheral monocytes
Cellular metabolism of hematopoetic stem cells and peripheral monocytes
Background summary
The Bacillus Calmette-Guerin (BCG) vaccine not only protects aginst
mycobacterium tuberculosis, but has also been shown to reduce morbidity and
mortality caused by non-related infections. This effect is likely due to
non-specific, epigenetically mediated immunomodulatory effects, at least in
part on the inate immune system, but the precise mechanism of the protective
effect of BCG on non-mycobacterial infections is not fully known. The effects
of BCG of the innate immune system last up to 3 months to 1 year and cannot be
explained by a direct effect on the effector cells of the innate immune system.
During the process of hematopoesis mature peripheral blood cells are produced
from hematopoetic stem and progenitor cells in the bone marrow. Stimulation of
hematopoetic stem cells can lead to functionally different progenitor cells.
BCG vaccination could possibly lead to changes in hematopoetic stem cells which
lead to the observed long term changes in the innate immune system after BCG
vaccination.
Study objective
To examine the effect of BCG vaccination on the composition and function of the
bone marrow.
Study design
A prospective, randomized, placebo controlelled, open-label, blinded end-point
trial. Healthy volunteers will be randomized in 2 groups. Group 1 will be
vaccinated with placebo, group 2 will be vaccinated with BCG. Before
vaccination and two weeks after vaccination blood will be drawn and bone marrow
aspiration will be performed. Volunteers allocated to the BCG group will
undergo a FDG-PET-CT scan before and three months after vaccination
Intervention
Group 1: placebo vaccination.
Group 2: BCG vaccination.
Study burden and risks
BCG vaccine is a registered vaccine that has been shown to be safe. Mild side
effects such as local skin reactions are possible. Bone marrow aspiration is a
safe procedure, that is generally well tolerated if performed by experienced
personnel. Both blood donation and bone marrow aspiration will only be
performed by experienced personnel in this study.
There are no direct benefits to participants apart from the benefit conferred
by BCG vaccination in participants who plan on going abroad for medical work,
but these results will potentially lead to novel strategies to optimize
vaccination policies.
Geert Grooteplein-Zuid 10
Nijmegen 6500HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
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 >8mmol/l
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL55825.091.15 |
| OMON | NL-OMON24361 |