BCG-induced Epigenetic Modifications in the NEXT Generation (NEXT)

April 9, 2024 updated by: Radboud University Medical Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DNA methylation profile of sperm cells (first comparison; CHANGE)
Time Frame: Comparing T3 to baseline
Differentially methylated regions (DMRs)
Comparing T3 to baseline
DNA methylation profile of sperm cells (second comparison; CHANGE)
Time Frame: Comparing T4 to baseline
Differentially methylated regions (DMRs)
Comparing T4 to baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological profile of PBMCs, before and after BCG vaccination (comparison; CHANGE)
Time Frame: Comparing T1-T4 to baseline
Cytokine production assays (e.g. TNFa, IL6, IL1b)
Comparing T1-T4 to baseline
CHANGE of the epigenetic profile of innate immune cells
Time Frame: Comparing T1-T4 to baseline
Differentially methylated regions (DMRs), ATAC sequencing, RNA sequencing
Comparing T1-T4 to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114192
  • 2023-503344-14-00 (Other Identifier: CTIS number (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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