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posted on 03.02.2021, 18:51 by Joseph A. Politch, Susan Cu-Uvin, Thomas R. Moench, Karen T. Tashima, Jai G. Marathe, Kate M. Guthrie, Howard Cabral, Tara Nyhuis, Miles Brennan, Larry Zeitlin, Hans M. L. Spiegel, Kenneth H. Mayer, Kevin J. Whaley, Deborah J. Anderson

VRC01-N and HSV8-N concentrations (represented by medians with interquartile ranges) in cervicovaginal TearFlo samples in Segments A and B (Active film group only). (A). Segment A, VRC01-N: All 4 sites significantly elevated at 1 hour (p < 0.001 for all site comparisons) and 4 hours (p < 0.001 for cervical os, ectocervix, and mid vagina sites; p = 0.007 for distal vagina) post single film insertion compared to respective baseline concentrations. Cervical os (p = 0.046) and ectocervix (p = 0.02) were elevated 24 hours post film insertion. Mid (p = 0.09) and distal vagina (p = 0.54) were not significantly elevated 24 hours post film insertion. (B). Segment A, HSV8-N: All sites were significantly elevated at 1 hour and 4 hours post single film insertion (p < 0.001 for all comparisons) but not at the 24-hour time point. (C). Segment B, VRC01-N: All 4 sites were significantly elevated at 1 (p < 0.001 for all site comparisons) and 4 (p < 0.001 for all site comparisons) hours following first film insertion compared to each site’s respective baseline concentration. Concentrations at all 4 sites 24 hours after first film and 24 hours after seventh film remained significantly elevated compared to Baseline (p < 0.001 for distal vagina, ectocervix, and mid vagina sites and p = 0.01 for cervical os for Baseline vs. 24 hours post first film, and p < 0.001 for distal vagina, ectocervix, and mid vagina sites and p = 0.0007 for cervical os for Baseline vs. 24 post seventh film). (D). Segment B, HSV8-N: All 4 sites were significantly elevated at 1 and 4 hours following first film insertion compared to Baseline concentrations. Concentrations at all 4 sites at 24 hours after first film and 24 hours after seventh film remained significantly elevated compared to Baseline (p < 0.001 for all comparisons).

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