2024-514428-18-00招募中4 期
(Pre-BCGvacc) BCG vaccination: can pre-vaccination immune status predict outcome?
Leids Universitair Medisch Centrum (LUMC)1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月21日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Induction of mycobacterial growth control measured in vitro by MGIA (1 log reduction post vaccination compared to inoculum). Level of control in MGIA will be used as classifier to assess pre-vaccination functional status.
研究概览
简要总结
Determine the pre-vaccination functional immune profile in correlation with effector immunity post vaccination.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Healthy participant
- •Age 18-55 year
- •Signed written Informed Consent
- •Willingness and ability to adhere to the study regimen
- •Naïve for tuberculosis, i.e. a negative QuantiFERON® -TB Gold In-Tube test result according to the manufacturer’s specifications at screening.
- •Negative for HIV, i.e. a negative HIV test at screening.
排除标准
- •History of TB disease or treatment
- •Positive pregnancy test at screening or at month 6 (before 2nd vaccination)
- •Women of child bearing potential not willing to use contraceptives during the study, or if breastfeeding
- •History of keloid formation
- •Active participation in other clinical trials
- •Does not consent to us informing the participant’s General Practitioner of the BCG vaccination and of any uncommon, rare or serious adverse events
- •Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial
- •BCG or Rabies vaccination at any time prior to entering the trial (through taking medical history, presence of typical BCG scar or vaccination card)
- •Live vaccination (measles, mumps, rubella, oral polio, oral typhoid or yellow fever) 4 weeks or less prior to the BCG vaccination
- •Treatment with immune modulating drugs (e.g. systemic steroids, azathioprine, cyclosporine, anti-TNFα, immunoglobulines, cytostatics) 6 months or less prior to enrollment
- •(History of) disease affecting the lymphoid organs (e.g. Hodgkin’s disease, lymphoma, leukemia, sarcoidosis)
- •Known congenital or acquired immune deficiencies
- •Positive HIV test result at screening
- •Fever or antibiotic treatment 2 weeks or less prior to enrollment
- •Known hypersensitivity to any of the vaccine’s components
结局指标
主要结局
Induction of mycobacterial growth control measured in vitro by MGIA (1 log reduction post vaccination compared to inoculum). Level of control in MGIA will be used as classifier to assess pre-vaccination functional status.
Induction of mycobacterial growth control measured in vitro by MGIA (1 log reduction post vaccination compared to inoculum). Level of control in MGIA will be used as classifier to assess pre-vaccination functional status.
次要结局
- Imaging of dermal biopsies and correlation of relative subset distribution with functional mycobacterial growth control in MGIA. Frequencies of subsets in the dermis will be correlated with MGIA control capacity.
- Correlates of protection for both BCG (MGIA as best available correlate) and Rabipur (neutralizing antibodies) vaccinations will be compared and correlated.
- Correlation between cell frequencies and functional read outs prevaccination and at multiple post vaccination time points
- Correlation of metabolic state to effector immune responses such as measured by MGIA and intracellular cytokine secretion.
研究者
dr S.A. Joosten
Scientific
Leids Universitair Medisch Centrum (LUMC)
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A study to see how well CVGBM vaccine works at different doses and how safe it is in patients who had surgery for glioblastoma or astrocytoma2022-501423-25-00Curevac AG54
已完成
不适用
Immune repons induced by vaccination with BCGImmuunresponse by BCG vaccination Tuberculosis10028440NL-OMON37373eids Universitair Medisch Centrum25
Unknown
不适用
IMMUNE RESPONSE INDUCED BY VACCINATION WITH BCGlocal pain, irritation or discomfort at the injection site (immediately after the injection)=commonuncommon= headache, fever localenlargement of regional lymph node >1cm. Ulceration with a severe discharging ulcer at the site of injection.Rare: disseminated BCG complications such as osteitis or osteomyelitis, allergic reactions, including anaphylactic reactions. Local suppurative lymphadenitis, abscess formation.NL-OMON29225Performer; University Medical Center25
已完成
2 期
Effects of BCG on Influenza Induced Immune ResponseTrained ImmunityInfluenza Virus InfectionNCT02114255Radboud University Medical Center40
已完成
3 期
The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers. Two proof-of-principle studies.sepsisbacterial bloodstream infection1002766510004018NL-OMON40604niversitair Medisch Centrum Sint Radboud20