Trials / Unknown
UnknownNCT05766345
BCG-induced Epigenetic Modifications in the NEXT Generation
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Radboud University Medical Center · Academic / Other
- Sex
- Male
- Age
- 18 Years – 25 Years
- Healthy volunteers
- Accepted
Summary
Non-specific protective effects resulting from the BCG vaccine appear to be paternally inheritable. Since the BCG vaccine is known to induce trained immunity, epigenetics might explain the fathers' contribution to the immune profile of their offspring. Epigenetic inheritance in mice has recently been demonstrated, but is not established in humans yet. By studying the DNA methylation profile of sperm cells after BCG vaccination, we aim to gain insight into the possibility of epigenetic inheritance in human males.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331 | Nothing to add |
| BIOLOGICAL | Placebo | Nothing to add |
Timeline
- Start date
- 2023-10-02
- Primary completion
- 2024-08-01
- Completion
- 2024-10-01
- First posted
- 2023-03-13
- Last updated
- 2024-04-10
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05766345. Inclusion in this directory is not an endorsement.