Herpes GenitalisPhase 2HSV-2NCT02837575
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
A Phase 2 study testing VCL-HB01 and Phosphate-buffered saline in people with Herpes Genitalis, run by Vical at 15 sites in United States.
Trial summary
The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Genitalis
- What is being tested?
- VCL-HB01 and Phosphate-buffered saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2016to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HSV-2 seropositive
- A minimum of 1 year of reported history of genital herpes with recurrences.
Who cannot join
- History of receiving an investigational HSV vaccine
- Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes
- Pregnant or breastfeeding
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Alabama Vaccine Research Clinic at University of Alabama at Birmingham
Birmingham, Alabama, 35294-2050
University of North Carolina (UNC) Institute of Global Health and Infectious Diseases
Chapel Hill, North Carolina, 27599
University of Illinois
Chicago, Illinois, 60612
QPS Broward Research
Hollywood, Florida, 33024
Indiana University Infectious Disease Research
Indianapolis, Indiana, 46202
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Rochester Clinical Research, Inc.
Rochester, New York, 14609
University of Utah School of Medicine - Division of Infectious Diseases
Salt Lake City, Utah, 84132
Medical Center for Clinical Research
San Diego, California, 92108
University of Washington
Seattle, Washington, 98104
QPS Miami Research Associates
South Miami, Florida, 33143
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Heartland Research Associates, LLC
Wichita, Kansas, 67207
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults With Symptomatic Genital HSV-2 Infection
The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).
Read the detailed description
To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.
- Conditions
- Herpes Genitalis
- Being tested
- VCL-HB01, Phosphate-buffered saline
- Keywords
- HSV-2, Genital Herpes, Herpes, Herpes Simplex Virus, Type 2
- Medical subject headings
- Herpes Genitalis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCL-HB01Biological
Investigational Product
Phosphate-buffered salineOther
Also called PBS
Placebo
| Study group | Role | What they receive |
|---|---|---|
| VCL-HB01, 1-mL dose | Experimental | VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses Receives: Biological: VCL-HB01 |
| Phosphate-buffered saline, 1-mL dose | Placebo comparator | PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses Receives: Other: Phosphate-buffered saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion recurrences
Measured: Up to Day 450
Secondary outcomes (3)
Number of participants with adverse events
Measured: Up to Day 450
Time to first recurrence
Measured: Up to Day 450
Proportion of subjects recurrence-free
Measured: Up to Day 450
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes GenitalisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mammen P Mammen, MD, FIDSA, Study director, Vical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837575
- Sponsor's protocol ID
- HSV2-201
- Acronym
- HSV-2
- Status last verified
- Feb 2019
- First submitted
- 13 Jul 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults With Symptomatic Genital HSV-2 Infection
- ClinicalTrials.gov ID
- NCT02837575
- Acronym / sponsor ID
- HSV-2 / HSV2-201
- Conditions
- Herpes Genitalis
- Keywords
- HSV-2, Genital Herpes, Herpes, Herpes Simplex Virus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- VicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).
Detailed description
To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VCL-HB01, 1-mL dose | Experimental | Biological: VCL-HB01VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses |
| Phosphate-buffered saline, 1-mL dose | Placebo comparator | Other: Phosphate-buffered salinePBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- HSV-2 seropositive
- A minimum of 1 year of reported history of genital herpes with recurrences.
Key exclusion criteria (3 listed)
- History of receiving an investigational HSV vaccine
- Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes
- Pregnant or breastfeeding
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 |
|---|---|---|
| VCL-HB01Investigational Product | Biological | VCL-HB01, 1-mL dose |
| Phosphate-buffered salineAlso: PBSPlacebo | Other | Phosphate-buffered saline, 1-mL dose |
Primary outcome
Lesion recurrences
Time frame: Up to Day 450
3 secondary outcomes
Number of participants with adverse events
Time frame: Up to Day 450
Time to first recurrence
Time frame: Up to Day 450
Proportion of subjects recurrence-free
Time frame: Up to Day 450
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Herpes Genitalis
Active, not recruitingPhase 1
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Genital Herpes Simplex Type 2
Enrolling by invitationPhase 1
A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) Post-Vaccination
Genital Herpes
Not yet recruitingPhase 2
Evaluating Safety and Efficacy of Repeat Doses of UB-621in Adult Patients With Recurrent Genital Herpes
Recurrent Genital Herpes
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.
Mammen P Mammen, MD, FIDSA study director
Vical
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VCL-HB01 and Phosphate-buffered saline in people with Herpes Genitalis, run by Vical at 15 sites in United States.
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 2 inclusion and 3 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lesion recurrences (time frame: Up to Day 450). 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 27 Feb 2019.