Genital Herpes, HSV-2 Infection
Conditions
Keywords
Barrier cream
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.
Interventions
DEVICEVIBLOK barrier cream
VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.
Sponsors
Applied Clinical Services BV
UMC Utrecht
University of Rotterdam, The Netherlands
University of Washington
EB FlevoResearch BV
PreCare Trial & Recruitment B.V.
CLJI Worldwide
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
Vials with the sample will be coded. The assessor does not know the coding.
Intervention model description
Trial participants take extra-genital swabs before and after application of the barrier cream.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Device Effects | 26-32 days | Percentage SADE's in the as treated population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HSV-2 Detection Rate in AT Population | 26-32 days | Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK. |
| HSV-2 Copy Number in AT Population | 26-32 days | Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK. |
| ADE Description | 1-33 days | Nature and frequency of (possible) device related adverse events. |
Countries
Netherlands
Participant flow
Recruitment details
Upon written informed consent, 82 subjects were enrolled based on their medical history of recurrent genital herpes.
Pre-assignment details
Of the 82 subjects enrolled, 46 had a confirmed HSV-2 infection and started applying VIBLOK.
Participants by arm
| Arm | Count |
|---|---|
| As Treated Population Participants that applied VIBLOK at least once | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | As Treated Population |
|---|---|
| Age, Continuous | 33.3 years STANDARD_DEVIATION 10.68 |
| HSV-1 co-infection | 15 Participants |
| Number of recurrences past year | 5.7 episodes STANDARD_DEVIATION 2.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 7 Participants |
| Years since diagnosis genital herpes | 5.8 years STANDARD_DEVIATION 6.26 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 39 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
Serious Adverse Device Effects
Percentage SADE's in the as treated population.
Time frame: 26-32 days
Population: 46 eligible subjects that applied VIBLOK for an average of 27.2 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| During VIBLOK Application | Serious Adverse Device Effects | 0 Percentage SADE's |
Comparison: 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%.95% CI: [0, 7.7]
Secondary
ADE Description
Nature and frequency of (possible) device related adverse events.
Time frame: 1-33 days
Population: AT Population that applied VIBLOK at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| During VIBLOK Application | ADE Description | Toxic reaction | 0 Count of participants per ADE type |
| During VIBLOK Application | ADE Description | Possible allergic reaction | 2 Count of participants per ADE type |
| During VIBLOK Application | ADE Description | Itching/tingling/burning sensation | 19 Count of participants per ADE type |
| During VIBLOK Application | ADE Description | Infection | 0 Count of participants per ADE type |
Secondary
HSV-2 Copy Number in AT Population
Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.
Time frame: 26-32 days
Population: A total of 25 out of 46 subjects in the AT population had days with asymptomatic HSV shedding.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| During VIBLOK Application | HSV-2 Copy Number in AT Population | 100446.2 HSV copy number |
| After VIBLOK | HSV-2 Copy Number in AT Population | 43691.8 HSV copy number |
p-value: 0.013Wilcoxon (Mann-Whitney)
Secondary
HSV-2 Detection Rate in AT Population
Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.
Time frame: 26-32 days
Population: 45 subjects that returned swabs before and after VIBLOK application.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| During VIBLOK Application | HSV-2 Detection Rate in AT Population | 2.9 Mean number of swabs with shedding |
| After VIBLOK | HSV-2 Detection Rate in AT Population | 2.6 Mean number of swabs with shedding |
Comparison: 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.p-value: 0.248Wilcoxon (Mann-Whitney)