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

Status
Completed
Phase
I
Principal Investigator(s)
Susan Cu-Uvin, MD
Objective

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).

Last updated January 27, 2022

Prevention Option(s)
Antibody Related Research
Combination Prevention
Microbicides
Multipurpose Prevention Technologies
Study Design
Randomized
Blind
Arms and Assigned Interventions
Description
Segment A: Single MB66 Administration 10 mg of HSV8-N and 10 mg of VRC01-N monoclonal antibodies per MB66 film
Mode of Delivery
Film
Products
VRC01
ARMs
Experimental
Description
Segment B: Repeated Administrations Placebo Film The placebo film is composed of the identical excipients as MB66 without the monoclonal antibodies.
Mode of Delivery
Film
Products
VRC01
ARMs
Placebo Comparator
Description
Segment B: Repeated Administrations MB66 10 mg of HSV8-N and 10 mg of VRC01-N monoclonal antibodies per MB66 film
Mode of Delivery
Film
Products
VRC01
ARMs
Placebo Comparator
Trial Sponsors
ZabBio Inc., National Institute of Allergy and Infectious Diseases (NIAID), Boston University, The Miriam Hospital
January 2016
July 2018
Enrollment
38
18
Years
45
Years
Population
Women
Sites

Miriam Hospital

Providence, RI
United States of America