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(Pre-BCGvacc) BCG vaccination: can pre-vaccination immune status predict outcome?

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514428-18-00
Enrollment
50
Registered
2025-07-21
Start date
2025-10-24
Completion date
Unknown
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

health volunteerst

Brief summary

Induction of mycobacterial growth control measured in vitro by MGIA (1 log reduction post vaccination compared to inoculum). Level of control in MGIA will be used as classifier to assess pre-vaccination functional status.

Detailed description

Imaging of dermal biopsies and correlation of relative subset distribution with functional mycobacterial growth control in MGIA. Frequencies of subsets in the dermis will be correlated with MGIA control capacity., Correlates of protection for both BCG (MGIA as best available correlate) and Rabipur (neutralizing antibodies) vaccinations will be compared and correlated., Correlation between cell frequencies and functional read outs prevaccination and at multiple post vaccination time points, Correlation of metabolic state to effector immune responses such as measured by MGIA and intracellular cytokine secretion.

Interventions

DRUGBCG VACCINE AJV por és oldószer szuszpenziós injekcióhoz BCG vakcina
DRUGfagyasztva szárított

Sponsors

Leids Universitair Medisch Centrum (LUMC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Induction of mycobacterial growth control measured in vitro by MGIA (1 log reduction post vaccination compared to inoculum). Level of control in MGIA will be used as classifier to assess pre-vaccination functional status.

Secondary

MeasureTime frame
Imaging of dermal biopsies and correlation of relative subset distribution with functional mycobacterial growth control in MGIA. Frequencies of subsets in the dermis will be correlated with MGIA control capacity., Correlates of protection for both BCG (MGIA as best available correlate) and Rabipur (neutralizing antibodies) vaccinations will be compared and correlated., Correlation between cell frequencies and functional read outs prevaccination and at multiple post vaccination time points, Correlation of metabolic state to effector immune responses such as measured by MGIA and intracellular cytokine secretion.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026