SAFE: The VIBLOK SAfety and perFormancE Trial

• Sponsor: CLJI Worldwide (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03080961
• Collaborator: Applied Clinical Services BV (Other), UMC Utrecht (Other), University of Rotterdam, The Netherlands (Other), University of Washington (Other), EB FlevoResearch BV (Other), PreCare Trial & Recruitment B.V. (Other)
• Enrollment: 82
• Locations: 3
• Arm: 1
• Actual Duration (Months): 7.6
• Patients Per Site: 27.3
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HSV-2 Infection; Genital Herpes	Device: VIBLOK barrier cream	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Trial participants take extra-genital swabs before and after application of the barrier cream.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.
• Primary Purpose: Prevention
• Official Title: The VIBLOK SAfety and perFormancE Trial
• Actual Study Start Date: Mar 27, 2017
• Actual Primary Completion Date: Nov 13, 2017
• Actual Study Completion Date: Nov 13, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Serious Adverse Device Effects [26-32 days]

   Percentage SADE's in the as treated population.

Secondary Outcome Measures

1. HSV-2 Detection Rate in AT Population [26-32 days]

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

2. HSV-2 Copy Number in AT Population [26-32 days]

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

3. ADE Description [1-33 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EB FlevoResearch	Almere	Flevoland	Netherlands	1311 RL
2	PT&R	Beek	Limburg	Netherlands	6191 JW
3	EB UtrechtResearch	Utrecht		Netherlands	3511 NH

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Vivienne vd Walle, MD, PreCare Trial & Recruitment B.V.

Study Documents (Full-Text)

• Study Protocol - May 1, 2017
• Statistical Analysis Plan - Nov 3, 2017

More Information

Publications

None provided.

• Responsible Party: CLJI Worldwide
• ClinicalTrials.gov Identifier: NCT03080961
• Other Study ID Numbers: 2015-01
• First Posted: Mar 15, 2017
• Last Update Posted: Feb 13, 2020
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by CLJI Worldwide: Barrier cream
• Additional relevant MeSH terms: Herpes Genitalis

Study Results

Participant Flow

Recruitment Details	Upon written informed consent, 82 subjects were enrolled based on their medical history of recurrent genital herpes.
Pre-assignment Detail	Of the 82 subjects enrolled, 46 had a confirmed HSV-2 infection and started applying VIBLOK.

Arm/Group Title	Treatment Group
Arm/Group Description	46 subjects with a confirmed HSV-2 infection, took external genital skin swabs before and after applying minimally 0.8 pack (~4 ml) of VIBLOK per swab session.
Period Title: Overall Study
STARTED	46
COMPLETED	43
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	As Treated Population
Arm/Group Description	Participants that applied VIBLOK at least once
Overall Participants	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.3 (10.68)
Sex: Female, Male (Count of Participants)
Female	39 84.8%
Male	7 15.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 4.3%
White	35 76.1%
More than one race	2 4.3%
Unknown or Not Reported	7 15.2%
HSV-1 co-infection (Count of Participants)
Count of Participants [Participants]	15 32.6%
Number of recurrences past year (episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [episodes]	5.7 (2.60)
Years since diagnosis genital herpes (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.8 (6.26)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

46 eligible subjects that applied VIBLOK for an average of 27.2 days.

Arm/Group Title	During VIBLOK Application
Arm/Group Description	Percentage SADE's in subjects applying VIBLOK for a minimum of 26 days.
Measure Participants	46
Number (95% Confidence Interval) [Percentage SADE's]	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	During VIBLOK Application
	Comments	SADE rate after minimally 26 days of VIBLOK treatment will be assessed by calculating the upper limit of the 2-sided exact 95% Clopper-Pearson confidence interval which needs to be below 10%. With a sample size of 36, an exact two-sided 95.0% confidence interval for a single proportion would show that the SADE incidence is below 10% at an expected incidence of 0.1%.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	SADE percentage
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; 0.0 to 7.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

45 subjects that returned swabs before and after VIBLOK application.

Arm/Group Title	Before VIBLOK	After VIBLOK
Arm/Group Description	Days with HSV detection in the external genital area before application of VIBLOK.	Days with HSV detection in the external genital area after application of VIBLOK.
Measure Participants	45	45
Mean (95% Confidence Interval) [Mean number of swabs with shedding]	2.9	2.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	During VIBLOK Application, After VIBLOK
	Comments	Statistical analysis will evaluate the difference in detection rate between pre and post-VIBLOK swabs. For each person the number of swabs with shedding only pre-VIBLOK will be assessed, and then the number of swabs with shedding only post-VIBLOK will be subtracted. A number above 0 indicates a decreased detection rate after VIBLOK. With an 8% anticipated asymptomatic shedding rate, 80% power, 50 subjects taking samples for 28 days are needed to show a 50% reduction.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.248
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

A total of 25 out of 46 subjects in the AT population had days with asymptomatic HSV shedding.

Arm/Group Title	Before VIBLOK	After VIBLOK
Arm/Group Description	HSV amount in external genital swabs on days with asymptomatic shedding before applying VIBLOK.	HSV amount in external genital swabs on days with asymptomatic shedding after applying VIBLOK.
Measure Participants	25	25
Mean (95% Confidence Interval) [HSV copy number]	100446.2	43691.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	During VIBLOK Application, After VIBLOK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.013
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	ADE Description
Description	Nature and frequency of (possible) device related adverse events.
Time Frame	1-33 days

Outcome Measure Data

Analysis Population Description

AT Population that applied VIBLOK at least once.

Arm/Group Title	During VIBLOK Application
Arm/Group Description	Subjects that applied VIBLOK at least once.
Measure Participants	46
Toxic reaction	0 0%
Possible allergic reaction	2 4.3%
Itching/tingling/burning sensation	19 41.3%
Infection	0 0%

Adverse Events

Time Frame	Adverse Events were collected from the first day of VIBLOK application until 30 days after the last visit to the research clinic.
Adverse Event Reporting Description	Definitions are applied conform ISO 14155; 2011.
Arm/Group Title	During VIBLOK Application
Arm/Group Description	All AEs were recorded in subjects in all subjects applying VIBLOK at least once until 30 days after the last visit to the research clinic.
All Cause Mortality
	During VIBLOK Application
	Affected / at Risk (%)	# Events
Total	0/46 (0%)
Serious Adverse Events
	During VIBLOK Application
	Affected / at Risk (%)	# Events
Total	0/46 (0%)
Other (Not Including Serious) Adverse Events
	During VIBLOK Application
	Affected / at Risk (%)	# Events
Total	39/46 (84.8%)
General disorders
Other, undefined	4/46 (8.7%)	4
Infections and infestations
Not-device related infection	11/46 (23.9%)	16
Injury, poisoning and procedural complications
Toxic reaction	0/46 (0%)	0
Respiratory, thoracic and mediastinal disorders
Possible not-device related allergic reaction	5/46 (10.9%)	5
Skin and subcutaneous tissue disorders
Possible device related allergic reaction	2/46 (4.3%)	2
Itching/tingling/burning sensation	19/46 (41.3%)	21
HSV recurrence	19/46 (41.3%)	29

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.