BCG-induced Epigenetic Modifications in the NEXT Generation
试验速览
- 阶段
- 4 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- DNA methylation profile of sperm cells (first comparison; CHANGE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-25 years (at the moment of trial start)
排除标准
- •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
研究组 & 干预措施
BCG vaccine
BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331 0.1ml (=0.0075mg) One-time vaccination intradermally
干预措施: BCG-Vaccine SSI [Statens Serum Institut]) Danish strain 1331 (Biological)
Placebo vaccine
0.9% NaCl placebo 0.1ml One-time vaccination intradermally
干预措施: Placebo (Biological)
结局指标
主要结局
DNA methylation profile of sperm cells (first comparison; CHANGE)
时间窗: Comparing T3 to baseline
Differentially methylated regions (DMRs)
DNA methylation profile of sperm cells (second comparison; CHANGE)
时间窗: Comparing T4 to baseline
Differentially methylated regions (DMRs)
次要结局
- 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)