Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film (MB66): A Phase I randomized trial
MB66 film is a multipurpose prevention technology (MPT) product with monoclonal antibodies (mAbs) against HIV-1 (VRC01-N) and HSV-1 and 2 (HSV8-N). The mAbs were produced by transient expression in Nicotiana benthamiana (N). We conducted a Phase I clinical trial to assess the safety, pharmacokinetics (PK), and ex vivo efficacy of single and repeated doses of MB66 when used intravaginally.
February 2021
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MB66 film is a multipurpose prevention technology (MPT) product with monoclonal antibodies (mAbs) against HIV-1 (VRC01-N) and HSV-1 and 2 (HSV8-N). The mAbs were produced by transient expression in Nicotiana benthamiana (N). We conducted a Phase I clinical trial to assess the safety, pharmacokinetics (PK), and ex vivo efficacy of single and repeated doses of MB66 when used intravaginally.
Authors:
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
Health Risks(s):
- HIV
- HPV
- STI / STD
Product type(s):
- ARVs
- MPTs
Topic(s):
- MPTs
- Development
- Trials
- Reproductive Health
Region(s)
- Global