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Review
. 2022 May 17:4:899277.
doi: 10.3389/frph.2022.899277. eCollection 2022.

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

Anna-Ursula Happel  1 , Aida Sivro  2   3 , Lenine Liebenberg  2   3 , Jo Ann Passmore  1   2   4 , Caroline M Mitchell  5   6   7
Affiliations
Review

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

Anna-Ursula Happel et al. Front Reprod Health. .

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.

Keywords: cytokines; female genital tract; live biotherapeutics; product development; safety.

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Conflict of interest statement

JP holds a patent for a Method for diagnosing an inflammatory condition in the female genital tract (EP3063542B1). CM receives grant funding from Merck, and has served as a consultant for Scynexis, Inc. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

References

    1. Yildirim S, Yeoman CJ, Janga SC, Thomas SM, Ho M, Leigh SR, et al. . Primate vaginal microbiomes exhibit species specificity without universal Lactobacillus dominance. ISME J. (2014) 8:2431–44. 10.1038/ismej.2014.90 - DOI - PMC - PubMed
    1. Stumpf RM, Wilson BA, Rivera A, Yildirim S, Yeoman CJ, Polk JD, et al. . The primate vaginal microbiome: comparative context and implications for human health and disease. Am J Phys Anthropol. (2013) 152(Suppl 57):119–34. 10.1002/ajpa.22395 - DOI - PubMed
    1. O'Hanlon DE, Brown SE, He X, Stennett CA, Robbins SJ, Johnston ED, et al. . Observational cohort study of the effect of a single lubricant exposure during transvaginal ultrasound on cell-shedding from the vaginal epithelium. PLoS ONE. (2021) 16:e0250153. 10.1371/journal.pone.0250153 - DOI - PMC - PubMed
    1. Wilkinson EM, Łaniewski P, Herbst-Kralovetz MM, Brotman RM. Personal and clinical vaginal lubricants: impact on local vaginal microenvironment and implications for epithelial cell host response and barrier function. J Infect Dis. (2019) 220:2009–18. 10.1093/infdis/jiz412 - DOI - PMC - PubMed
    1. Dezzutti CS, Brown ER, Moncla B, Russo J, Cost M, Wang L, et al. . Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS ONE. (2012) 7:e48328. 10.1371/journal.pone.0048328 - DOI - PMC - PubMed

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