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Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film (MB66): A Phase I randomized trial

PLoS Medicine Mar 14, 2021

Politch JA, Cu-Uvin S, Moench TR, et al. - Via performing a phase I clinical trial, researchers sought to determine the safety, pharmacokinetics (PK), and ex vivo efficacy of single and repeated doses of MB66, a vaginal film product containing monoclonal antibodies (mAbs) against HIV-1 (VRC01-N) and HSV-1 and 2 (HSV8-N). Healthy reproductive-aged, sexually abstinent women were enrolled in the clinical trial. In Segment A, a clinician inserted a single MB66 film into the vaginal posterior fornix in 9 women. In Segment B, they randomly assigned 29 women to MB66 (Active) or Placebo film groups and instructed them to insert 1 film vaginally for 7 consecutive days. There appeared no serious adverse events (AEs) linked with product use. In vaginal secretions, peak of antibody levels was observed in 1 hour postdosing with Active film and these levels remained significantly raised through 24 hours. Vaginal samples obtained 24 hours following MB66 insertion significantly neutralized both HIV-1 and HSV-2 ex vivo.

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