BCG-induced Epigenetic Modifications in the NEXT Generation

Epigenetics Clinical Trial

— NEXT  

Official title:

BCG-induced Epigenetic Modifications in the NEXT Generation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05766345
• Other study ID #: 114192
• Secondary ID: 2023-503344-14-0
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 2, 2023
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Epigenetics
• Trained Immunity

Intervention

Biological:
• BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331
Nothing to add
• Placebo
Nothing to add

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA methylation profile of sperm cells (first comparison; CHANGE)	Differentially methylated regions (DMRs)	Comparing T3 to baseline
Primary	DNA methylation profile of sperm cells (second comparison; CHANGE)	Differentially methylated regions (DMRs)	Comparing T4 to baseline
Secondary	Immunological profile of PBMCs, before and after BCG vaccination (comparison; CHANGE)	Cytokine production assays (e.g. TNFa, IL6, IL1b)	Comparing T1-T4 to baseline
Secondary	CHANGE of the epigenetic profile of innate immune cells	Differentially methylated regions (DMRs), ATAC sequencing, RNA sequencing	Comparing T1-T4 to baseline