BCG-induced Epigenetic Modifications in the NEXT Generation

NCT ID: NCT05766345

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2024-10-31

Brief 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

Trained Immunity; BCG Vaccine; Epigenetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

BCG vaccine

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Nothing to add

Placebo vaccine

0.9% NaCl placebo 0.1ml One-time vaccination intradermally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Nothing to add

Interventions

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

Nothing to add

Intervention Type: BIOLOGICAL

Placebo

Nothing to add

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboudumc

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

2023-503344-14-00

Identifier Type: OTHER

Identifier Source: secondary_id

114192

Identifier Type: -

Identifier Source: org_study_id