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

• Joseph A. Politch ,

  Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing

  * E-mail: politch@bu.edu, joseph.politch@bmc.org

  ¶‡ These authors share first authorship on this work.

  Affiliation Boston University School of Medicine, Department of Medicine, Boston, Massachusetts, United States of America

  https://orcid.org/0000-0002-7022-0135

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• Susan Cu-Uvin ,

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Writing – review & editing

  ¶‡ These authors share first authorship on this work.

  Affiliation Alpert Medical School of Brown University, Department of Obstetrics and Gynecology and Medicine, Providence, Rhode Island, United States of America

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• Thomas R. Moench,

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Validation, Writing – review & editing

  Affiliation Mapp Biopharmaceutical Inc., San Diego, California, United States of America

  ⨯
• Karen T. Tashima,

  Roles Investigation, Methodology, Project administration, Supervision, Validation, Writing – review & editing

  Affiliation Division of Infectious Diseases, Alpert Medical School of Brown University, Providence, Rhode Island, United States of America

  ⨯
• Jai G. Marathe,

  Roles Conceptualization, Data curation, Investigation, Methodology, Validation, Writing – review & editing

  Affiliation Boston University School of Medicine, Department of Medicine, Boston, Massachusetts, United States of America

  ⨯
• Kate M. Guthrie,

  Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Supervision, Validation, Writing – review & editing

  Affiliation Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, Rhode Island, United States of America

  https://orcid.org/0000-0002-5528-1212

  ⨯
• Howard Cabral,

  Roles Conceptualization, Formal analysis, Methodology, Supervision, Validation, Writing – review & editing

  Affiliation Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, United States of America

  https://orcid.org/0000-0002-1185-8331

  ⨯
• Tara Nyhuis,

  Roles Conceptualization, Funding acquisition, Methodology, Project administration, Resources, Supervision, Validation, Writing – review & editing

  Affiliation Mapp Biopharmaceutical Inc., San Diego, California, United States of America

  ⨯
• Miles Brennan,

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Supervision, Validation, Writing – review & editing

  Affiliation Mapp Biopharmaceutical Inc., San Diego, California, United States of America

  ⨯
• Larry Zeitlin,

  Roles Conceptualization, Funding acquisition, Methodology, Project administration, Writing – review & editing

  Affiliation Mapp Biopharmaceutical Inc., San Diego, California, United States of America

  https://orcid.org/0000-0002-6857-1024

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• Hans M. L. Spiegel,

  Roles Conceptualization, Supervision, Validation, Writing – review & editing

  Affiliation Kelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Rockville, Maryland, United States of America

  https://orcid.org/0000-0001-9552-789X

  ⨯
• Kenneth H. Mayer,

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Validation, Writing – review & editing

  Affiliation Harvard Medical School, Department of Medicine, Boston, Massachusetts, United States of America

  https://orcid.org/0000-0001-7460-733X

  ⨯
• Kevin J. Whaley,

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Validation, Writing – review & editing

  Affiliation Mapp Biopharmaceutical Inc., San Diego, California, United States of America

  https://orcid.org/0000-0003-3856-6803

  ⨯
• Deborah J. Anderson

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Validation, Writing – original draft, Writing – review & editing

  Affiliation Boston University School of Medicine, Department of Medicine, Boston, Massachusetts, United States of America

  ⨯