The VIBLOK SAfety and perFormancE Trial (SAFE)

Genital herpes has a high prevalence in industrialized as well as developing countries.

Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be transmitted mother to child during birth with possible serious consequences.

Medical treatments and condoms only partially reduce the risk for transmission from/ to sexual partners. Genital herpes transmission despite use of condoms is thought to be due to transfer via skin-to-skin contact in unprotected areas, and HSV-2 transmission may be enhanced by current shaving habits in the genital area leading to micro lesions (lacerations) of the skin.

VIBLOK™ is a cream designed to impede the passage of viruses, such as HSV-2, across the skin. Bench and animal experiments indicate that it can block virus transmission such as HSV-2 over 80%.

The objective of the SAFE trial is to assess the safety and performance of VIBLOK in adults with HSV-2 infection by comparing virus detection in the extra-genital area before and after application of the barrier cream.

Study Overview

• Status: Completed
• Conditions: Genital Herpes; HSV-2 Infection
• Intervention / Treatment: Device: VIBLOK barrier cream

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3511 NH
    • EB UtrechtResearch
  • Flevoland
    • Almere, Flevoland, Netherlands, 1311 RL
      • EB FlevoResearch
  • Limburg
    • Beek, Limburg, Netherlands, 6191 JW
      • PT&R

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participant is male or female and at least 18 years of age
2. HSV-2 seropositive by the UW Western blot or Alegria assay
3. History of recurrent genital herpes with at least 3 recurrences in the last year or, if currently on suppressive/ prophylactic therapy, prior to starting the therapy (antiviral therapy has to be stopped at least 7 days prior to initiation of the trial product).
4. General good health at the discretion of the investigator.
5. Willing to not use any topical genital therapy aside from the study device for the duration of the trial.
6. Willing to not use any systemic anti HSV therapy during the entire study starting 7 days prior to baseline.
7. Willing to obtain 2 swabs from external-genital areas once daily for the duration of the trial.
8. Willing to keep a daily trial diary during the treatment period.
9. Negative pregnancy test for women at screening.
10. Willing to use contraceptives for the duration of the study.
11. Subject must be willing and able (in the opinion of the investigator) to understand the patient information and informed consent form and to comply with the clinical trial protocol and procedures.
12. Subject must be willing to give written informed consent.

Exclusion Criteria:

1. Serious medical conditions, such as diabetes, significant autoimmune disease, cancer or immunosuppression, etc. that at the discretion of the investigator will likely affect study outcomes
2. Treatment with systemic steroids or other immune-modulating agents
3. Participation in any investigational drug or device trial within 30 days prior to screening.
4. Pregnancy or breastfeeding, in case of women.
5. Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Before and after VIBLOK; The degree to which HSV-2 is blocked by the VIBLOK cream is determined by comparing the amount of HSV in the external genital area before and after application of the cream. So participants are their own control.	Device: VIBLOK barrier cream; VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Device Effects	Percentage SADE's in the as treated population.	26-32 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HSV-2 Detection Rate in AT Population	Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.	26-32 days
HSV-2 Copy Number in AT Population	Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.	26-32 days
ADE Description	Nature and frequency of (possible) device related adverse events.	1-33 days

Collaborators and Investigators

• Sponsor: CLJI Worldwide
• Collaborators: UMC Utrecht; University of Washington; University of Rotterdam, The Netherlands; Applied Clinical Services BV; EB FlevoResearch BV; PreCare Trial & Recruitment B.V.
• Investigators: Principal Investigator: Vivienne vd Walle, MD, PreCare Trial & Recruitment B.V.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): November 13, 2017
• Study Completion (Actual): November 13, 2017

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Barrier cream
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Simplex; Herpes Genitalis
• Other Study ID Numbers: 2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No