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

NCT02579083 | Completed Phase 1 DMC

• 2 other identifiers: MB66-01U19AI096398
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

HIV; Herpes Simplex Infections

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade 2 or higher Adverse Events deemed related to study product

  Grade 2 or higher Adverse Events

  Segment A, cumulative events to Day 7; Segment B, cumulative events to Day 10

Secondary Outcomes (3)

• Naked eye visual assessment during speculum exam of the degree of film dissolution

  1, 4, and 24 hours after dosing

• Concentrations of MB66 antibodies in vaginal fluid sampled with Tear Flo (filter paper) wicks, and measured by enzyme linked immunosorbent assay (ELISA)

  Pre-dose, 1 hr and 4 hr post dose, day 1, day 6-10 and day 12-16 (Segment B only)

• Concentrations of MB66 antibodies in serum by ELISA

  Screening visit, day 1, day 6-10 and day 12-16 (segment B only)

Study Arms (3)

Segment A: Single MB66 Administration

EXPERIMENTAL

10 mg of HSV8-N and 10 mg of VRC01-N monoclonal antibodies per MB66 film

Drug: MB66

Segment B: Repeated Administrations Placebo Film

PLACEBO COMPARATOR

The placebo film is composed of the identical excipients as MB66 without the monoclonal antibodies.

Drug: Placebo Film

Segment B: Repeated Administrations MB66

EXPERIMENTAL

10 mg of HSV8-N and 10 mg of VRC01-N monoclonal antibodies per MB66 film

Drug: MB66

Interventions

MB66 DRUG

10 mg of HSV8-N and 10 mg of VRC01-N monoclonal antibodies per MB66 film

Also known as: Investigational Product

Segment A: Single MB66 Administration; Segment B: Repeated Administrations MB66

Placebo Film DRUG

The placebo film is composed of the identical excipients as MB66 without the monoclonal antibodies.

Also known as: Placebo

Segment B: Repeated Administrations Placebo Film

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 through 45 years (inclusive) at screening
• Able and willing to provide written informed consent to be screened for and enrolled in the study
• Able and willing to provide adequate locator information at screening
• HIV-uninfected based on testing performed by study staff at
• In general good health as determined by the site clinician
• Agree to abstain from any vaginal insertions, including products, douches, devices such as sex toys, or penile or oral intercourse from 5 days prior to Visit 2 (Enrollment Visit) until the final Study Visit (one week after last dose of study film). Only tampons during menses and clinically indicated speculum exams are allowed.
• Agree to use condoms provided by the study staff from one week after last use of study film until three weeks after last use of study film
• Willingness to undergo all study-related assessments and follow all study-related procedures
• Be currently using an effective method of contraception at enrollment (used continuously and with good compliance for the past 60 days as determined by participant self-report) with plans to continue use throughout the study period. Acceptable methods include any hormonal method (except vaginal ring); intrauterine device (IUD) inserted at least 90 days prior to enrollment; female sterilization; abstinent from sexual activity with male partner for the past 60 days; sexual activity with vasectomized partner; engages in sex exclusively with women.
• For participants 21 and older, a Pap result in the 36 calendar months prior to the Enrollment Visit consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events satisfactory evaluation with no treatment required of non-Grade 0 Pap result per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines or per local standard of care, within the last 36 calendar months prior to enrollment. Note: For participants aged 18-21, a Grade-0 or adequately evaluated abnormal Pap smear is not required as the American Society for Colposcopy and Cervical Pathology recommends initiating screening at age 21.
• At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products while enrolled in this trial -

You may not qualify if:

• Menopausal at screening (as defined as amenorrhea or irregular periods for one year or more without an alternative etiology)
• Hysterectomy
• Known adverse reaction to any of the study products (ever)
• Known adverse reaction to latex (ever)
• Non-therapeutic injection drug use in the 12 months prior to screening
• Surgical procedure involving the pelvis in the 90 days prior to screening (includes dilation and curettage or evacuation, and cryosurgery; does not include cervical biopsy for evaluation of an abnormal pap smear or IUD placement)
• Participation in a drug, spermicide and/or microbicide study in the 30 days prior to screening or anticipated participation in an investigational drug study in the next 8 weeks
• Pregnancy within 90 days prior to screening
• Lactating
• Use of a diaphragm, NuvaRing®, or spermicide for contraception
• As determined by the PI, a degree of menstrual cycle irregularity that would make it difficult to schedule follow up visits without interruption by menses
• Active sexually transmitted infection or documented treatment of sexually transmitted infections in the last 6 months, including, but not limited to: chlamydia, gonorrhea, syphilis, trichomonas, cervicitis or pelvic inflammatory disease, or currently active HSV lesions or other sores. (Participants seropositive for or with a history of HSV without current active lesions will not be excluded.)
• Women who by history engage in condom-less intercourse with HIV-infected partners, or who exchange sex for money, shelter, or gifts, or who in the opinion of the investigators, may be at risk for HIV acquisition during the duration of the study
• More than one sex partner within the past 3 months
• Current sexual partner known by participant to be HIV seropositive

Sponsors & Collaborators

• KBio Inc: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Boston University: collaborator
• The Miriam Hospital: collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• Politch JA, Cu-Uvin S, Moench TR, Tashima KT, Marathe JG, Guthrie KM, Cabral H, Nyhuis T, Brennan M, Zeitlin L, Spiegel HML, Mayer KH, Whaley KJ, Anderson DJ. Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film (MB66): A Phase I randomized trial. PLoS Med. 2021 Feb 3;18(2):e1003495. doi: 10.1371/journal.pmed.1003495. eCollection 2021 Feb.

  PMID: 33534791 DERIVED

MeSH Terms

Conditions

Herpes Simplex

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 19, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

US (1)