Bollen, Liesbeth, Kelly Blanchard, Peter Kilmarx, Supaporn Chaikummao, Cathy Connolly, Punneporn Wasinrapee, Jullapong Achalapong, Janet McNicholl, and Jordan Tappero. "No increase in cervicovaginal pro-inflammatory cytokines after Carraguard^® use."

Abstract

BACKGROUND: Biomarkers, such as cytokines, may be helpful to assess subclinical epithelial inflammation in evaluating safety of candidate vaginal microbicides.

METHODOLOGY: 55 HIV-negative Thai women were enrolled in a safety trial of Carraguard™ and randomized to use Carraguard gel or placebo gel during vaginal sex. Cervicovaginal lavages were collected at baseline and after one month of gel use; levels of pro-inflammatory cytokines (Interleukin [IL]-6, IL-8, IL-1β) and anti-inflammatory cytokines (IL-10, secretory leukocyte protease inhibitor [SLPI]) were measured using a microwell plate-based enzyme immunoassay (Quantikine EIA). Median cytokine values were compared between baseline and follow-up visits using a paired t-test; the change between groups was compared using a Wilcoxon Rank Sum test.

RESULTS: IL-6 and IL-8 values tended to decrease during the study in both groups (p-values > 0.1). The difference between baseline and follow-up values was not significantly different between Carraguard and placebo groups (IL-6: 6.1pg/mL vs. 4.0 pg/mL; p=0.3 and IL-8: 116.3 pg/mL vs. 95.4 pg/mL; p=0.8). No differences were observed in IL-1β, IL-10, and SLPI values.

CONCLUSION: Our findings showed no increase in pro-inflammatory cytokines, suggesting that both Carraguard and placebo gels do not cause inflammation. The role of cytokines to assess epithelial safety should be further explored.

Poster Session
Monday, 24 April 2006, 12:30–1:30 pm
Tuesday, 25 April 2006, 12:30–1:30 pm

Microbicides 2006

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This page updated 6 April 2006

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