BCG-induced epigenetic modifications in the NEXT generatio

Phase 4

Recruiting

• Conditions: Epigenetics; molecules on top of/surrounding DNA; 10021879

• Registration Number: NL-OMON53174
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Male
18-25 years old
Healthy

Exclusion Criteria

Any systemic disease or condition, or the use of systemic medication
Smoking
Prior BCG vaccination
Other vaccination four weeks prior to trial start or four weeks after the first
study visit
Acute illness 2 weeks prior to trial start
Known allergy or anaphylaxis/serious adverse reaction to any vaccine
Participation in another drug trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is the change in DNA methylation signatures of sperm cells in<br /><br>the intervention group, from<br /><br>baseline to 3 and 6 months after BCG vaccination, in comparison to a<br /><br>placebo-treated group</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Functional assessment of immune cell populations in both groups, at all<br /><br>timepoints.</p><br>