Genital Herpes Simplex Type 2Phase 1/2NCT02030301
Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
A Phase 1/2 study testing VCL-HB01, VCL-HM01 and PBS in people with Genital Herpes Simplex Type 2, run by Vical at 7 sites in United States.
Trial summary
The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Genital Herpes Simplex Type 2
- What is being tested?
- VCL-HB01, VCL-HM01 and PBS
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2013to Feb 2016
- Phase
- Phase 1/2
- 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 and either 2 to 9 recurrences within the year prior to screening or 2 to 9 recurrences per year prior to starting suppressive therapy
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
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Alabama Vaccine Research Clinic
Birmingham, Alabama, 35294
Broward Research Group
Hollywood, Florida, 33024
Center for Clinical Studies
Houston, Texas, 77004
Indiana University Infectious Diseases Research
Indianapolis, Indiana, 46202
Westover Heights Clinic
Portland, Oregon, 97210
University of Utah - Division of Infectious Diseases
Salt Lake City, Utah, 84132
University of Washington Medical Center
Seattle, Washington, 98104
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 Therapeutic DNA Vaccines in Symptomatic HSV-2-Seropositive Adults
The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).
Read the detailed description
This is a dose escalation study to evaluate the safety, immunogenicity, and efficacy of 3 doses of HSV plasmid DNA (pDNA) vaccines formulated with Vaxfectin® in subjects with a minimum of 1 year of reported history of genital herpes, and either 2 to 9 recurrences within the year prior to screening, or 2 to 9 recurrences per year prior to starting suppressive therapy.
- Conditions
- Genital Herpes Simplex Type 2
- Being tested
- VCL-HB01, VCL-HM01, PBS
- Keywords
- Herpes Simplex Virus, Type 2, Herpes, HSV-2
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCL-HB01Biological
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
VCL-HM01Biological
Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®
PBSBiological
Phosphate-buffered saline
| Study group | Role | What they receive |
|---|---|---|
| VCL-HB01, 0.25-mL dose | Experimental | VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses Receives: Biological: VCL-HB01 |
| PBS, 0.25-mL dose | Placebo comparator | PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses Receives: Biological: PBS |
| VCL-HB01, 0.5-mL dose | Experimental | VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses Receives: Biological: VCL-HB01 |
| PBS, 0.5-mL dose | Placebo comparator | PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses Receives: Biological: PBS |
| VCL-HB01, 1-mL dose | Experimental | VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses Receives: Biological: VCL-HB01 |
| VCL-HM01, 1-mL dose | Experimental | VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses Receives: Biological: VCL-HM01 |
| PBS, 1-mL dose | Placebo comparator | PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses Receives: Biological: PBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to Day 420
Viral shedding rate change from baseline
Measured: Baseline, Day 150
Secondary outcomes (5)
Genital lesion rate change from baseline
Measured: Baseline, Day 150
HSV DNA copy numbers change from baseline
Measured: Baseline, Day 150
Genital recurrence rate compared with placebo
Measured: Up to Day 330
Subclinical genital shedding rate change from baseline
Measured: Up to Day 150
T-cell and/or antibody responses change from baseline
Measured: Baseline, Days 7, 35, 63, 150, 330
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Herpes Simplex Type 2Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mammen P. Mammen, Jr., MD, FIDSA, Study director, Vical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030301
- Sponsor's protocol ID
- HSV2-101
- Status last verified
- Feb 2019
- First submitted
- 20 Dec 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- 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, Dose-Escalation, Phase 1/2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 Therapeutic DNA Vaccines in Symptomatic HSV-2-Seropositive Adults
- ClinicalTrials.gov ID
- NCT02030301
- Acronym / sponsor ID
- HSV2-101
- Conditions
- Genital Herpes Simplex Type 2
- Keywords
- Herpes Simplex Virus, Type 2, Herpes, HSV-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- VicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Jan 2014 (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 study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).
Detailed description
This is a dose escalation study to evaluate the safety, immunogenicity, and efficacy of 3 doses of HSV plasmid DNA (pDNA) vaccines formulated with Vaxfectin® in subjects with a minimum of 1 year of reported history of genital herpes, and either 2 to 9 recurrences within the year prior to screening, or 2 to 9 recurrences per year prior to starting suppressive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| VCL-HB01, 0.25-mL dose | Experimental | Biological: VCL-HB01VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses |
| PBS, 0.25-mL dose | Placebo comparator | Biological: PBSPBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses |
| VCL-HB01, 0.5-mL dose | Experimental | Biological: VCL-HB01VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses |
| PBS, 0.5-mL dose | Placebo comparator | Biological: PBSPBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses |
| VCL-HB01, 1-mL dose | Experimental | Biological: VCL-HB01VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses |
| VCL-HM01, 1-mL dose | Experimental | Biological: VCL-HM01VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses |
| PBS, 1-mL dose | Placebo comparator | Biological: PBSPBS, 1-mL dose by intramuscular injection once every 28 days for 3 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 and either 2 to 9 recurrences within the year prior to screening or 2 to 9 recurrences per year prior to starting suppressive therapy
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-HB01Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin® | Biological | VCL-HB01, 0.25-mL dose, VCL-HB01, 0.5-mL dose, VCL-HB01, 1-mL dose |
| VCL-HM01Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin® | Biological | VCL-HM01, 1-mL dose |
| PBSPhosphate-buffered saline | Biological | PBS, 0.25-mL dose, PBS, 0.5-mL dose, PBS, 1-mL dose |
Primary outcome
Number of participants with adverse events
Time frame: Up to Day 420
Viral shedding rate change from baseline
Time frame: Baseline, Day 150
5 secondary outcomes
Genital lesion rate change from baseline
Time frame: Baseline, Day 150
HSV DNA copy numbers change from baseline
Time frame: Baseline, Day 150
Genital recurrence rate compared with placebo
Time frame: Up to Day 330
Subclinical genital shedding rate change from baseline
Time frame: Up to Day 150
T-cell and/or antibody responses change from baseline
Time frame: Baseline, Days 7, 35, 63, 150, 330
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 Genital Herpes Simplex Type 2
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A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
Genital Herpes Simplex Type 2
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, Jr., MD, FIDSA study director
Vical
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VCL-HB01, VCL-HM01 and PBS in people with Genital Herpes Simplex Type 2, run by Vical at 7 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 7 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants with adverse events (time frame: Up to Day 420). The study lists 2 primary outcomes in all. 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; AzTrials last refreshed its copy on 8 Nov 2026.