AUTHOR=Happel Anna-Ursula , Sivro Aida , Liebenberg Lenine , Passmore Jo Ann , Mitchell Caroline M. TITLE=Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products JOURNAL=Frontiers in Reproductive Health VOLUME=4 YEAR=2022 URL=https://www.frontiersin.org/journals/reproductive-health/articles/10.3389/frph.2022.899277 DOI=10.3389/frph.2022.899277 ISSN=2673-3153 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.