Safety Study of Monoclonal Antibodies to Reduce the Vaginal Transmission of HSV and HIV

Summary

The purpose of this study is to assess the safety and pharmacokinetics of MB66, a monoclonal antibody film for vaginal application that is being developed to potentially reduce the transmission of herpes simplex virus (HSV) and human immunodeficiency virus (HIV).

Timeline

Start

2016-01

Primary completion

2018-07

Completion

2018-07

Publications

• Politch JA, Cu-Uvin S, Moench TR, Tashima KT, Marathe JG, Guthrie KM, Cabral H, Nyhuis T, Brennan M, Zeitlin L, Spiegel HML, Mayer KH, Whaley KJ, Anderson DJ. Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film (MB66): A Phase I randomized trial. PLoS Med. 2021 Feb 3;18(2):e1003495. doi: 10.1371/journal.pmed.1003495. eCollection 2021 Feb.

Drugs

Indications