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

Understanding variability of immune responses to BCG vaccination: a systems biology approach - Determinants of the response to BCG vaccine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45603

Enrollment

300

Registered

2017-04-24

Start date

2017-04-10

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

BCG vaccine tuberculosis vaccine

Interventions

BCG vaccine.

BCG vaccine

Innate immunity

Systems biology

Trained immunity

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Age>18 Healthy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1) Immune cell function: - ex vivo cytokine responses of monocytes - immunophenotype of cell subpopulations 2) Genetic variation 3) Epigenetic, transcription and metabolic profiles relating to immune function of peripheral monocytes 4) Microbiome variation	—

Secondary

Measure	Time frame
- Metadata (clinical, environmental data) - Skin inflammation at vaccination site	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)