BCG-induced Epigenetic Modifications in the NEXT Generation

NCT05766345 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Radboud University Medical Center
Phase	Phase 4
Status	UNKNOWN
Enrolment	36
Start date	2023-10-02
Completion	2024-10

Conditions

• Trained Immunity
• BCG Vaccine
• Epigenetics

Interventions

• BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331
• Placebo

Primary outcomes

• DNA methylation profile of sperm cells (first comparison; CHANGE) — Comparing T3 to baseline
  Differentially methylated regions (DMRs)
• DNA methylation profile of sperm cells (second comparison; CHANGE) — Comparing T4 to baseline
  Differentially methylated regions (DMRs)

Countries

Netherlands