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Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products

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...

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Autores principales: Happel, Anna-Ursula, Sivro, Aida, Liebenberg, Lenine, Passmore, Jo Ann, Mitchell, Caroline M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9580790/
https://www.ncbi.nlm.nih.gov/pubmed/36303630
http://dx.doi.org/10.3389/frph.2022.899277
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author Happel, Anna-Ursula
Sivro, Aida
Liebenberg, Lenine
Passmore, Jo Ann
Mitchell, Caroline M.
author_facet Happel, Anna-Ursula
Sivro, Aida
Liebenberg, Lenine
Passmore, Jo Ann
Mitchell, Caroline M.
author_sort Happel, Anna-Ursula
collection PubMed
description 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.
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spelling pubmed-95807902022-10-26 Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products Happel, Anna-Ursula Sivro, Aida Liebenberg, Lenine Passmore, Jo Ann Mitchell, Caroline M. Front Reprod Health Reproductive Health 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. Frontiers Media S.A. 2022-05-17 /pmc/articles/PMC9580790/ /pubmed/36303630 http://dx.doi.org/10.3389/frph.2022.899277 Text en Copyright © 2022 Happel, Sivro, Liebenberg, Passmore and Mitchell. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Reproductive Health
Happel, Anna-Ursula
Sivro, Aida
Liebenberg, Lenine
Passmore, Jo Ann
Mitchell, Caroline M.
Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products
title Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products
title_full Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products
title_fullStr Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products
title_full_unstemmed Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products
title_short Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products
title_sort considerations for choosing soluble immune markers to determine safety of novel vaginal products
topic Reproductive Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9580790/
https://www.ncbi.nlm.nih.gov/pubmed/36303630
http://dx.doi.org/10.3389/frph.2022.899277
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