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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

Viral neutralization and antibody pharmacokinetics (represented by means ± SEMs) in CVLs in Segments A and B (Active film group only). Neutralization percent is represented by solid lines/circles () (left y axis), and antibody concentration is represented by dashed lines/open triangles () (right y axis) in each graph. (A). VRC01-N concentration and HIVQ23-17 neutralization in Segment A were significantly increased at 24 hours post single film insertion compared to both Baseline (p = 0.006 and 0.01, respectively) and 7 days post single film insertion (p = 0.006 and 0.02, respectively). (B). HSV8-N concentrations in Segment A were significantly increased at 24 hours post single film insertion compared to both Baseline (p = 0.04) and 7 days post single film insertion (p = 0.01). All CVL samples from 24 hours post film insertion exhibited 100% HSV neutralization; however, the omnibus F test p-value did not reach statistical significance (p = 0.052). (C). VRC01-N concentration and HIVQ23-17 neutralization in Segment B were significantly elevated 24 hours after first film and 24 hours after seventh film compared to Baseline (p < 0.001 for all comparisons). (D). In Segment B, HSV8-N concentrations 24 hours after first film and 24 hours after seventh film did not differ significantly from Baseline (p = 0.056, Group x Visit interaction), but HSV neutralization was significantly increased at 24 hours post first film (p = 0.003) and 24 hours post seventh film compared to Baseline (p = 0.001).

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