drugset / Trial / NCT05766345

BCG-induced Epigenetic Modifications in the NEXT Generation

NCT05766345 ↗

Phase 4 Unknown 36 enrolled Radboud University Medical Center
RandomizedParallel-groupSingle-blindBasic science

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.

Timeline

Start
2023-10-02
Primary completion
2024-08
Completion
2024-10

Drugs

EvaluationDrugModalityDoseRoute
Subject BCG vaccine SSI Vaccine 0.0075 mg Other
Subject BCG vaccine SSI Vaccine 0.1 ml Other

Indications

No indication recorded.