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, MPTs
Study Design:Blind, Randomized
Arms and Assigned Interventions
DescriptionSegment A: Single MB66 Administration 10 mg of HSV8-N and 10 mg of VRC01-N monoclonal antibodies per MB66 film
Mode of DeliveryFilm
ARMsExperimental
DescriptionSegment B: Repeated Administrations Placebo Film The placebo film is composed of the identical excipients as MB66 without the monoclonal antibodies.
Mode of DeliveryFilm
ARMsPlacebo Comparator
DescriptionSegment B: Repeated Administrations MB66 10 mg of HSV8-N and 10 mg of VRC01-N monoclonal antibodies per MB66 film
Mode of DeliveryFilm
ARMsPlacebo Comparator
Results: Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film
Official Code: NCT02579083
Trial Sponsors: Boston University, NIAID, The Miriam Hospital, ZabBio Inc.
Start Date
End Date
January 4, 2016
July 1, 2018
Enrollment:38
Age range: 18 Years ↔ 45 Years
Population:Cisgender Women