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(Pre-BCGvacc) BCG vaccination: can pre-vaccination immune status predict outcome?
EU CTIS ID: 2024-514428-18-00
What this study is testing
Determine the pre-vaccination functional immune profile in correlation with effector immunity post vaccination.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Healthy participant
- Age 18-55 year
- Signed written Informed Consent
- Willingness and ability to adhere to the study regimen
- Naïve for tuberculosis, i.e. a negative QuantiFERON® -TB Gold In-Tube test result according to the manufacturer’s specifications at screening.
- Negative for HIV, i.e. a negative HIV test at screening.
You likely can't join if
- History of TB disease or treatment
- Positive pregnancy test at screening or at month 6 (before 2nd vaccination)
- Women of child bearing potential not willing to use contraceptives during the study, or if breastfeeding
- History of keloid formation
- Active participation in other clinical trials
- Does not consent to us informing the participant’s General Practitioner of the BCG vaccination and of any uncommon, rare or serious adverse events
See the full eligibility criteria
- Healthy participant
- Age 18-55 year
- Signed written Informed Consent
- Willingness and ability to adhere to the study regimen
- Naïve for tuberculosis, i.e. a negative QuantiFERON® -TB Gold In-Tube test result according to the manufacturer’s specifications at screening.
- Negative for HIV, i.e. a negative HIV test at screening.
- History of TB disease or treatment
- Positive pregnancy test at screening or at month 6 (before 2nd vaccination)
- Women of child bearing potential not willing to use contraceptives during the study, or if breastfeeding
- History of keloid formation
- Active participation in other clinical trials
- Does not consent to us informing the participant’s General Practitioner of the BCG vaccination and of any uncommon, rare or serious adverse events
- Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial
- BCG or Rabies vaccination at any time prior to entering the trial (through taking medical history, presence of typical BCG scar or vaccination card)
- Live vaccination (measles, mumps, rubella, oral polio, oral typhoid or yellow fever) 4 weeks or less prior to the BCG vaccination
- Treatment with immune modulating drugs (e.g. systemic steroids, azathioprine, cyclosporine, anti-TNFα, immunoglobulines, cytostatics) 6 months or less prior to enrollment
- (History of) disease affecting the lymphoid organs (e.g. Hodgkin’s disease, lymphoma, leukemia, sarcoidosis)
- Known congenital or acquired immune deficiencies
- Positive HIV test result at screening
- Fever or antibiotic treatment 2 weeks or less prior to enrollment
- Known hypersensitivity to any of the vaccine’s components
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.