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Updated: Aug 23, 2025

Collection, Isolation, and Flow Cytometric Analysis of Human Endocervical Samples
Published on: July 6, 2014
Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products
Anna-Ursula Happel1, Aida Sivro2,3, Lenine Liebenberg2,3
1Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Abstract:
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.

