选择可溶性免疫标志物以确定新型阴道产品安全性的考量因素。
Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products.
作者信息
Happel Anna-Ursula, Sivro Aida, Liebenberg Lenine, Passmore Jo Ann, Mitchell Caroline M
机构信息
Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
出版信息
Front Reprod Health. 2022 May 17;4:899277. doi: 10.3389/frph.2022.899277. eCollection 2022.
Several soluble cytokines have been associated with microbicide-induced cervicovaginal inflammation, non-optimal vaginal microbiota, and risk of HIV acquisition. Many of these biomarkers are used in preclinical assays to estimate the safety of vaginally applied products. However, there are currently no validated biomarkers to evaluate the safety of novel vaginal products in clinical trials. This hinders the rapid and rational selection of novel products being tested in first-in-human trials. We reviewed available literature to assess how best to select and measure soluble immune markers to determine product safety in first in human clinical trials of novel vaginal products.
几种可溶性细胞因子与杀微生物剂引起的宫颈阴道炎症、不理想的阴道微生物群以及感染艾滋病毒的风险有关。其中许多生物标志物用于临床前检测，以评估阴道应用产品的安全性。然而，目前尚无经过验证的生物标志物来评估新型阴道产品在临床试验中的安全性。这阻碍了在首次人体试验中对新型产品进行快速合理的选择。我们查阅了现有文献，以评估如何最好地选择和测量可溶性免疫标志物，从而在新型阴道产品的首次人体临床试验中确定产品安全性。
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