Cargando…
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...
Autores principales: | , , , , |
---|---|
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 |
_version_ | 1784812471023828992 |
---|---|
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. |
format | Online Article Text |
id | pubmed-9580790 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT happelannaursula considerationsforchoosingsolubleimmunemarkerstodeterminesafetyofnovelvaginalproducts AT sivroaida considerationsforchoosingsolubleimmunemarkerstodeterminesafetyofnovelvaginalproducts AT liebenberglenine considerationsforchoosingsolubleimmunemarkerstodeterminesafetyofnovelvaginalproducts AT passmorejoann considerationsforchoosingsolubleimmunemarkerstodeterminesafetyofnovelvaginalproducts AT mitchellcarolinem considerationsforchoosingsolubleimmunemarkerstodeterminesafetyofnovelvaginalproducts |