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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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