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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503344-14-00 | Other Identifier | CTIS number (EMA) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCG vaccine | Experimental | BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331 0.1ml (=0.0075mg) One-time vaccination intradermally |
|
| Placebo vaccine | Placebo Comparator | 0.9% NaCl placebo 0.1ml One-time vaccination intradermally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331 | Biological | Nothing to add |
| |
| Measure | Description | Time Frame |
|---|---|---|
| DNA methylation profile of sperm cells (first comparison; CHANGE) | Differentially methylated regions (DMRs) | Comparing T3 to baseline |
| DNA methylation profile of sperm cells (second comparison; CHANGE) | Differentially methylated regions (DMRs) | Comparing T4 to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological profile of PBMCs, before and after BCG vaccination (comparison; CHANGE) | Cytokine production assays (e.g. TNFa, IL6, IL1b) | Comparing T1-T4 to baseline |
| CHANGE of the epigenetic profile of innate immune cells |
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Inclusion Criteria:
Exclusion Criteria:
The purpose of this study is to study sperm cells, therefore only male individuals can participate
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | 6525AG | Netherlands |
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| Placebo |
| Biological |
Nothing to add |
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Differentially methylated regions (DMRs), ATAC sequencing, RNA sequencing
| Comparing T1-T4 to baseline |