HSV-2 InfectionSAFENCT03080961
The VIBLOK SAfety and perFormancE Trial
A study testing VIBLOK barrier cream in people with HSV-2 Infection and Genital Herpes, run by CLJI Worldwide at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HSV-2 Infection, Genital Herpes
- What is being tested?
- VIBLOK barrier cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesNetherlands
- Study dates
- 27 Mar 2017to 13 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
EB FlevoResearch
Almere Stad, Flevoland, 1311 RL
PT&R
Beek, Limburg, 6191 JW
EB UtrechtResearch
Utrecht, 3511 NH
About this study
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.
Read more
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.
- Conditions
- HSV-2 Infection, Genital Herpes
- Being tested
- VIBLOK barrier cream
- Keywords
- Barrier cream
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIBLOK barrier creamDevice
VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.
| Study group | Role | What they receive |
|---|---|---|
| Before and after VIBLOK | Experimental | 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. Receives: Device: VIBLOK barrier cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Device Effects
Percentage SADE's in the as treated population.
Measured: 26-32 days
Secondary outcomes (3)
HSV-2 Detection Rate in AT Population
Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.
Measured: 26-32 days
HSV-2 Copy Number in AT Population
Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.
Measured: 26-32 days
ADE Description
Nature and frequency of (possible) device related adverse events.
Measured: 1-33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start27 Mar 2017
- Primary completion13 Nov 2017
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HSV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Trial participants take extra-genital swabs before and after application of the barrier cream.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- CLJI Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Applied Clinical Services BV, UMC Utrecht, University of Rotterdam, The Netherlands, University of Washington, EB FlevoResearch BV, PreCare Trial & Recruitment B.V.
- Responsible party
- Sponsor
- Investigators
- Vivienne vd Walle, MD, Principal investigator, PreCare Trial & Recruitment B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080961
- Sponsor's protocol ID
- 2015-01
- Acronym
- SAFE
- Status last verified
- Oct 2019
- First submitted
- 9 Mar 2017
- Last updated
- 13 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VIBLOK SAfety and perFormancE Trial
- ClinicalTrials.gov ID
- NCT03080961
- Acronym / sponsor ID
- SAFE / 2015-01
- Conditions
- HSV-2 Infection, Genital Herpes
- Keywords
- Barrier cream
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- CLJI WorldwideIndustry (pharma, biotech, devices)
- Collaborators
- Applied Clinical Services BV, UMC Utrecht, University of Rotterdam, The Netherlands, University of Washington, EB FlevoResearch BV, PreCare Trial & Recruitment B.V.
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Posted 13 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Trial participants take extra-genital swabs before and after application of the barrier cream.
| Arm | Type | Receives |
|---|---|---|
| Before and after VIBLOK | Experimental | Device: VIBLOK barrier creamThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIBLOK barrier creamVIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection. | Device | Before and after VIBLOK |
Primary outcome
Serious Adverse Device Effects
Time frame: 26-32 days
Percentage SADE's in the as treated population.
3 secondary outcomes
HSV-2 Detection Rate in AT Population
Time frame: 26-32 days
HSV-2 Copy Number in AT Population
Time frame: 26-32 days
ADE Description
Time frame: 1-33 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivienne vd Walle, MD principal investigator
PreCare Trial & Recruitment B.V.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIBLOK barrier cream in people with HSV-2 Infection and Genital Herpes, run by CLJI Worldwide at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Device Effects (time frame: 26-32 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.