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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

24 Oct 2025 → ongoing

Decision date (initial)

2025-07-21

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

LUMC Stimuleringsfonds immunologist Joosten

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Determine the pre-vaccination functional immune profile in correlation with effector immunity post vaccination.

Secondary objectives 4

1. Determine prevaccination intradermal immune composition in correlation with effector immunity post vaccination.
2. Correlate vaccine responsiveness against 2 unrelated vaccines to identify intrinsic donor characteristics.
3. Correlation between blood cellular immune parameters before and after vaccination
4. Determination of immune cell metabolic state by Scenith in correlation to vaccine induced effector responses

Conditions and MedDRA coding

health volunteerst

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Healthy participant
2. Age 18-55 year
3. Signed written Informed Consent
4. Willingness and ability to adhere to the study regimen
5. Naïve for tuberculosis, i.e. a negative QuantiFERON® -TB Gold In-Tube test result according to the manufacturer’s specifications at screening.
6. Negative for HIV, i.e. a negative HIV test at screening.

Exclusion criteria 15

1. History of TB disease or treatment
2. BCG or Rabies vaccination at any time prior to entering the trial (through taking medical history, presence of typical BCG scar or vaccination card)
3. Live vaccination (measles, mumps, rubella, oral polio, oral typhoid or yellow fever) 4 weeks or less prior to the BCG vaccination
4. Treatment with immune modulating drugs (e.g. systemic steroids, azathioprine, cyclosporine, anti-TNFα, immunoglobulines, cytostatics) 6 months or less prior to enrollment
5. (History of) disease affecting the lymphoid organs (e.g. Hodgkin’s disease, lymphoma, leukemia, sarcoidosis)
6. Known congenital or acquired immune deficiencies
7. Positive HIV test result at screening
8. Fever or antibiotic treatment 2 weeks or less prior to enrollment
9. Known hypersensitivity to any of the vaccine’s components
10. Positive pregnancy test at screening or at month 6 (before 2nd vaccination)
11. Women of child bearing potential not willing to use contraceptives during the study, or if breastfeeding
12. History of keloid formation
13. Active participation in other clinical trials
14. Does not consent to us informing the participant’s General Practitioner of the BCG vaccination and of any uncommon, rare or serious adverse events
15. Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 4

1. 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.
2. Correlates of protection for both BCG (MGIA as best available correlate) and Rabipur (neutralizing antibodies) vaccinations will be compared and correlated.
3. Correlation between cell frequencies and functional read outs prevaccination and at multiple post vaccination time points
4. Correlation of metabolic state to effector immune responses such as measured by MGIA and intracellular cytokine secretion.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Leids Universitair Medisch Centrum (LUMC)

Sponsor organisation

Leids Universitair Medisch Centrum (LUMC)

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

dr S.A. Joosten

Public contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

dr S.A. Joosten

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications