nderstanding variability of immune responses to BCG vaccination: a systems biology approach

Completed

• Conditions: BCG vaccine; tuberculosis vaccine; 10021460; 10019815

• Registration Number: NL-OMON45603
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

Age>18
Healthy

Exclusion Criteria

Use of chronic or acute medication during the last month before the study other than oral anti-contraceptive drugs
Vaccination within 3 months prior to study period
Medical history of disease associated with immune deficiency
Previous BCG vaccination
Contact with tuberculosis patients or born in a tuberculosis endemic country
Acute (febrile) illness within 4 weeks prior to start of study
Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Immune cell function:<br /><br>- ex vivo cytokine responses of monocytes<br /><br>- immunophenotype of cell subpopulations<br /><br>2) Genetic variation<br /><br>3) Epigenetic, transcription and metabolic profiles relating to immune function<br /><br>of peripheral monocytes<br /><br>4) Microbiome variation<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Metadata (clinical, environmental data)<br /><br>- Skin inflammation at vaccination site</p><br>