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BCG-induced Epigenetic Modifications in the NEXT Generation

Sponsor
Radboud University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05766345
Collaborator
(none)
40
Enrollment
2
Arms
6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331
  • Biological: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
BCG-induced Epigenetic Modifications in the NEXT Generation
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: BCG vaccine

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
Nothing to add
Placebo Comparator: Placebo vaccine

0.9% NaCl placebo 0.1ml One-time vaccination intradermally

Biological: Placebo
Nothing to add

Outcome Measures

Primary Outcome Measures

  1. DNA methylation profile of sperm cells (first comparison; CHANGE) [Comparing T3 to baseline]

    Differentially methylated regions (DMRs)

  2. DNA methylation profile of sperm cells (second comparison; CHANGE) [Comparing T4 to baseline]

    Differentially methylated regions (DMRs)

Secondary Outcome Measures

  1. Immunological profile of PBMCs, before and after BCG vaccination (comparison; CHANGE) [Comparing T1-T4 to baseline]

    Cytokine production assays (e.g. TNFa, IL6, IL1b)

  2. CHANGE of the epigenetic profile of innate immune cells [Comparing T1-T4 to baseline]

    Differentially methylated regions (DMRs), ATAC sequencing, RNA sequencing

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Radboud University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT05766345
Other Study ID Numbers:
  • 114192
  • 2023-503344-14-00
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
BCG Vaccine

Study Results

No Results Posted as of Mar 13, 2023