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

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.

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February 2021

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Resource Type:

Journal Article

Citation:

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

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