活微生物来增强抗SARS-CoV-2免疫力临床试验 (Live BASIC试验):一个三盲随机对照试验
Daniel B Horton1,2,3, Rahul Ukey4, Abhilasha Madhvi4
1Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA. daniel.horton@rutgers.edu.
Infection
|November 26, 2025
概括
一个活生生的微生物联盟 (OL-1) 显示出在之前感染过的未接种疫苗的成年人中提高抗SARS-CoV-2IgG水平的潜力. 标准剂量是有效的,而高剂量对免疫反应没有显著影响.
科学领域:
- 微生物学 微生物学
- 免疫学 免疫学 免疫学
- 传染性疾病 传染性疾病
背景情况:
- 由于免疫力下降和疫苗犹,COVID-19大流行仍在继续.
- 活微生物联盟OL-1含有具有交叉反应抗原 (CRAG) 的细菌,可刺激抗SARS-CoV-2免疫反应.
- 评估OL-1在未接种疫苗,先前感染的成年人中的有效性至关重要.
研究的目的:
- 评估OL-1在增强抗SARS-CoV-2免疫力的有效性.
- 评估标准剂量和高剂量的OL-1对免疫反应的影响.
- 确定OL-1在目标人群中的安全性和耐受性.
主要方法:
- 试点,三盲,随机对照试验,共52名参与者 (年龄18-60岁).
- 参与者是未接种疫苗的成年人,在4个月或更早之前感染了SARS-CoV-2.
- 干预涉及21天的标准剂量OL-1,高剂量OL-1或安慰剂.
主要成果:
- 标准剂量OL-1在第42天显著增加了与安慰剂相比的血抗SARS-CoV-2IgG水平 (p=0.02).
- 高剂量的OL-1并没有显示出IgG水平的显著变化.
- 在标准剂量OL-1下观察到干扰素玛 (IFNg) 释放的边际增加;没有检测到新的SARS-CoV-2感染.
结论:
- 在以前感染过的未接种疫苗的成年人中,OL-1被很好地容忍.
- 标准剂量OL-1与抗SARS-CoV-2IgG水平的增加有关.
- 需要进一步的研究来证实在更大的群体中发现和临床影响.
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