Considerations for Choosing Soluble Immune Markers to Determine Safety of Novel Vaginal Products
Year: 2022
Type: review
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.
Source: Frontiers in Reproductive Health
Institutions: University of Cape Town, Institute of Infectious Disease and Molecular Medicine, Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, National Health Laboratory Service, Harvard University, Ragon Institute of MGH, MIT and Harvard, Massachusetts General Hospital
Language: English
Subfield: Microbiology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $892
OpenAlex ID: W4280535899