严重免疫抑制艾滋病患者的HLA不匹配的全源采用免疫疗法:一个多中心,开放标签,受控的2a期研究
Tao Yang1, Zhiman Xie2, Zhe Xu1
1Senior Department of Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, People's Republic of China.
Emerging microbes & infections
|June 27, 2024
概括
全基因采用免疫疗法 (AAIT) 在改善艾滋病患者反复感染的免疫恢复方面表现有前途. 这种新疗法与ART结合,增强了CD4+T细胞计数,但没有增加不良事件.
科学领域:
- 免疫学 免疫学 免疫学
- 传染性疾病 传染性疾病
- 细胞疗法细胞疗法
背景情况:
- 复发性机会性感染 (OI) 对患有获得性免疫缺陷综合征 (AIDS) 的严重免疫抑制患者构成重大挑战,即使抗逆转录病毒疗法 (ART) 取得了进展.
- 现有的治疗方法往往无法完全恢复免疫功能,使患者易受危及生命的感染.
研究的目的:
- 评估HLA不匹配的全源采用免疫疗法 (AAIT) 的安全性和有效性,作为严重免疫抑制艾滋病患者的ART的辅助.
- 为了比较AAIT与ART结合的结果与传统的ART单独治疗方案.
主要方法:
- 进行了一项多中心,开放标签,受控的2a期试验.
- 患者接受了AAIT与ART结合或单独使用ART (对照组).
- 安全性 (不良事件) 和疗效 (CD4+T细胞恢复,免疫反应) 经过96周的评估.
主要成果:
- 在AAIT和对照组之间没有观察到不良事件的显著差异.
- 与对照组相比,AAIT治疗在72周和96周改善了CD4+T细胞的恢复 (P<0.05).
- 捐赠者/接受者的性别不匹配与在AAIT组实现免疫反应有显著的相关性 (OR=8.667,P=0.004).
结论:
- AAIT是一种安全且有前途的辅助疗法,用于改善严重免疫抑制的艾滋病患者的免疫恢复.
- 需要进一步的研究来阐明AAIT的免疫机制,并确定这种治疗的最佳患者亚群.
- 临床试验.gov的标识符:NCT04098770和NCT02651376.gov的标识符:NCT04098770和NCT02651376.
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