NCT05766345

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 10, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

January 16, 2023

Last Update Submit

April 9, 2024

Conditions

Trained ImmunityBCG VaccineEpigenetics

Outcome Measures

Primary Outcomes (2)

  • DNA methylation profile of sperm cells (first comparison; CHANGE)

    Differentially methylated regions (DMRs)

    Comparing T3 to baseline

  • DNA methylation profile of sperm cells (second comparison; CHANGE)

    Differentially methylated regions (DMRs)

    Comparing T4 to baseline

Secondary Outcomes (2)

  • Immunological profile of PBMCs, before and after BCG vaccination (comparison; CHANGE)

    Comparing T1-T4 to baseline

  • CHANGE of the epigenetic profile of innate immune cells

    Comparing T1-T4 to baseline

Study Arms (2)

BCG vaccine

EXPERIMENTAL

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

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

Placebo vaccine

PLACEBO COMPARATOR

0.9% NaCl placebo 0.1ml One-time vaccination intradermally

Biological: Placebo

Interventions

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

Nothing to add

BCG vaccine
PlaceboBIOLOGICAL

Nothing to add

Placebo vaccine

Eligibility Criteria

Age18 Years - 25 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe purpose of this study is to study sperm cells, therefore only male individuals can participate
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, 6525AG, Netherlands

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

March 13, 2023

Study Start

October 2, 2023

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

April 10, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)