BCG-induced Epigenetic Modifications in the NEXT Generation

Radboud University Medical Center

Status and phase: Active, not recruiting; Phase 4

Conditions: BCG Vaccine; Trained Immunity; Epigenetics

Treatments: Biological: BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331; Biological: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05766345

114192

2023-503344-14-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Male
• Age 18-25 years (at the moment of trial start)

Exclusion criteria

• Any systemic disease or conditin, or the use of systemic medication (with the exception of non-threatening alelrgies, e.g. hay fever)
• Smoking or drug use
• Prior BCG vaccination
• Other vaccination four weeks prior to trial start or four weeks after the first study visit (no vaccine in the same arm as the BCG vaccine for three months)
• Acute illness two weeks prior to trial start
• Known allergy or history of anaphylaxis/other serious adverse reaction to any vaccine
• Participation in another drug trial
• Legally incapacitated or unwilling to provide informed consent

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

BCG vaccine

Experimental group

Description:

BCG-Vaccine SSI \[Statens Serum Institut\]) Danish strain 1331 0.1ml (=0.0075mg) One-time vaccination intradermally

Treatment:

Biological: BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331

Placebo vaccine

Placebo Comparator group

Description:

0.9% NaCl placebo 0.1ml One-time vaccination intradermally

Treatment:

Biological: Placebo