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The VIBLOK SAfety and perFormancE Trial (SAFE)

Primary Purpose

HSV-2 Infection, Genital Herpes

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

VIBLOK barrier cream

About this trial

This is an interventional prevention trial for HSV-2 Infection focused on measuring Barrier cream

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participant is male or female and at least 18 years of age
HSV-2 seropositive by the UW Western blot or Alegria assay
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).
General good health at the discretion of the investigator.
Willing to not use any topical genital therapy aside from the study device for the duration of the trial.
Willing to not use any systemic anti HSV therapy during the entire study starting 7 days prior to baseline.
Willing to obtain 2 swabs from external-genital areas once daily for the duration of the trial.
Willing to keep a daily trial diary during the treatment period.
Negative pregnancy test for women at screening.
Willing to use contraceptives for the duration of the study.
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.
Subject must be willing to give written informed consent.

Exclusion Criteria:

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
Treatment with systemic steroids or other immune-modulating agents
Participation in any investigational drug or device trial within 30 days prior to screening.
Pregnancy or breastfeeding, in case of women.
Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.

Sites / Locations

EB FlevoResearch
PT&R
EB UtrechtResearch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Before and after VIBLOK

Arm Description

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.

Outcomes

Primary Outcome Measures

Serious Adverse Device Effects

Percentage SADE's in the as treated population.

Secondary Outcome Measures

HSV-2 Detection Rate in AT Population

Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.

HSV-2 Copy Number in AT Population

Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.

ADE Description

Nature and frequency of (possible) device related adverse events.

Full Information

NCT ID

NCT03080961

First Posted

March 9, 2017

Last Updated

February 12, 2020

Sponsor

CLJI Worldwide

Collaborators

Applied Clinical Services BV, UMC Utrecht, University of Rotterdam, The Netherlands, University of Washington, EB FlevoResearch BV, PreCare Trial & Recruitment B.V.

1. Study Identification

Unique Protocol Identification Number

NCT03080961

Brief Title

The VIBLOK SAfety and perFormancE Trial

Acronym

SAFE

Official Title

The VIBLOK SAfety and perFormancE Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

March 27, 2017 (Actual)

Primary Completion Date

November 13, 2017 (Actual)

Study Completion Date

November 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CLJI Worldwide

Collaborators

Applied Clinical Services BV, UMC Utrecht, University of Rotterdam, The Netherlands, University of Washington, EB FlevoResearch BV, PreCare Trial & Recruitment B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HSV-2 Infection, Genital Herpes

Keywords

Barrier cream

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Trial participants take extra-genital swabs before and after application of the barrier cream.

Masking

None (Open Label)

Masking Description

Vials with the sample will be coded. The assessor does not know the coding.

Allocation

N/A

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Before and after VIBLOK

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

VIBLOK barrier cream

Intervention Description

VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.

Primary Outcome Measure Information:

Title

Serious Adverse Device Effects

Description

Percentage SADE's in the as treated population.

Time Frame

26-32 days

Secondary Outcome Measure Information:

Title

HSV-2 Detection Rate in AT Population

Description

Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.

Time Frame

26-32 days

Title

HSV-2 Copy Number in AT Population

Description

Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.

Time Frame

26-32 days

Title

ADE Description

Description

Nature and frequency of (possible) device related adverse events.

Time Frame

1-33 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant is male or female and at least 18 years of age HSV-2 seropositive by the UW Western blot or Alegria assay 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). General good health at the discretion of the investigator. Willing to not use any topical genital therapy aside from the study device for the duration of the trial. Willing to not use any systemic anti HSV therapy during the entire study starting 7 days prior to baseline. Willing to obtain 2 swabs from external-genital areas once daily for the duration of the trial. Willing to keep a daily trial diary during the treatment period. Negative pregnancy test for women at screening. Willing to use contraceptives for the duration of the study. 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. Subject must be willing to give written informed consent. Exclusion Criteria: 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 Treatment with systemic steroids or other immune-modulating agents Participation in any investigational drug or device trial within 30 days prior to screening. Pregnancy or breastfeeding, in case of women. Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vivienne vd Walle, MD

Organizational Affiliation

PreCare Trial & Recruitment B.V.

Official's Role

Principal Investigator

Facility Information:

Facility Name

EB FlevoResearch

City

Almere

State/Province

Flevoland

ZIP/Postal Code

1311 RL

Country

Netherlands

Facility Name

PT&R

City

Beek

State/Province

Limburg

ZIP/Postal Code

6191 JW

Country

Netherlands

Facility Name

EB UtrechtResearch

City

Utrecht

ZIP/Postal Code

3511 NH

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

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The VIBLOK SAfety and perFormancE Trial

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