Genital HerpesPhase 2NCT03146403
Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
A Phase 2 study testing GEN-003, Matrix-M2 and 0.9% normal saline in people with Genital Herpes and HSV-2 Infection, run by Genocea Biosciences, Inc. at 8 sites in United States.
Trial summary
The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Genital Herpes, HSV-2 Infection
- What is being tested?
- GEN-003, Matrix-M2 and 0.9% normal saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 8 sitesUnited States
- Study dates
- 24 May 2017to 11 Jun 2018
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completed Study GEN-003-003
- Received all 3 GEN-003 doses (any dose combination) in Study GEN-003-003
- Received last dose of GEN-003 within 11 to 18 months prior
- Reported data in the daily electronic reporting period on at least 80% of days in Study GEN-003-003
- Collected at least 45 swabs (of 56 total expected swabs) during the Month 11 to 12 swab collection period in Study GEN-003-003
- Willing and able to provide written informed consent
- Willing to perform and comply with all study procedures
- Postmenopausal or willing to practice a highly effective method of contraception for 28 days before and 90 days after enrollment
Who cannot join
- Did not meet all eligibility criteria in Study GEN-003-003, or received incorrect treatment in Study GEN-003-003
- Use of suppressive antiviral medication within 14 days prior
- Use of topical steroids or antiviral medication in the anogenital region within 14 days prior
- Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV recurrence frequency or intensity within 14 days prior
- History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis
- Immunocompromised individuals
Show all 20Show fewer
- Diagnosis or suspicion of an AESI
- Diagnosis or suspicion of any other autoimmune disease not listed in Appendix 4 of the protocol
- Vaccine-related SAE in GEN-003-003
- Known current infection with HIV or hepatitis B or C virus
- History of hypersensitivity to any component of the vaccine
- Prior receipt of another vaccine containing HSV-2 antigens other than GEN-003
- Receipt of any IP within 30 days prior to the maintenance dose of GEN-003/placebo
- Receipt of any blood product within 90 days prior to the maintenance dose
- Receipt of a live vaccine within 28 days prior to or any other vaccine within 14 days prior to maintenance dose
- Planned use of any vaccine from the maintenance dose to 28 days after the maintenance dose
- Pregnant or nursing women
- History of drug or alcohol abuse
- Other active, uncontrolled comorbidities
- Changes to medication used to manage an underlying comorbidity within 60 days prior
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Tekton Research
Austin, Texas, 78745
University of Alabama Birmingham
Birmingham, Alabama, 35294
UNC Health
Chapel Hill, North Carolina, 27599
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
NW Dermatology and Research Clinic
Portland, Oregon, 97210
Medical Center for Clinical Research
San Diego, California, 92108
Optimus Medical Group
San Francisco, California, 94102
University of Washington
Seattle, Washington, 98104
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of a Maintenance Dose of GEN-003 in Subjects With Genital Herpes Infection
The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial of GEN-003 in subjects who have received previous doses of GEN-003 in the GEN-003-003 clinical trial. Eligible subjects will be randomized in a 1:1 ratio to receive 1 intramuscular (IM) dose (the maintenance dose) of GEN-003 or placebo.
Subjects will use a daily electronic reporting tool for reporting the presence or absence of genital herpes lesions, and severity of genital herpes symptoms.
GEN-003-005 was originally designed to follow subjects for 12 months after the maintenance dose but a business decision, unrelated to product safety, was made by Genocea Biosciences in 3Q2017 to cease GEN-003 spending and activities.
- Conditions
- Genital Herpes, HSV-2 Infection
- Being tested
- GEN-003, Matrix-M2, 0.9% normal saline
- Keywords
- HSV, Herpes, Genital Herpes, Vaccine
- 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.
GEN-003Biological
Also called HSV Therapeutic Vaccine
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2Biological
Also called Adjuvant
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
0.9% normal salineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GEN-003 | Experimental | 60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection Receives: Biological: GEN-003; Biological: Matrix-M2 |
| Placebo | Placebo comparator | 0.9% normal saline administered as a 0.5mL intramuscular (IM) injection Receives: Other: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Days With Genital Herpes Lesions
Subject-reported via electronic diary
Measured: The 6-month period after vaccination
Secondary outcomes (4)
Number of Genital Herpes Recurrences
Subject-reported via electronic diary
Measured: The 6-month period after vaccination
Number of Subjects Without Genital Herpes Recurrence
Subject-reported via electronic diary
Measured: 6 months after vaccination
Days Until First Genital Herpes Recurrence
Subject-reported via electronic diary
Measured: The 6-month period after vaccination
Duration of Genital Herpes Recurrences
Time in days per genital herpes recurrence
Measured: The 6-month period after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start24 May 2017
- Primary completion22 Dec 2017
- Study completion11 Jun 2018
Why it stopped: 2017 business decision to cease GEN-003 spending.
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 Genital HerpesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genocea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146403
- Sponsor's protocol ID
- GEN-003-005
- Status last verified
- Jan 2019
- First submitted
- 5 May 2017
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of a Maintenance Dose of GEN-003 in Subjects With Genital Herpes Infection
- ClinicalTrials.gov ID
- NCT03146403
- Acronym / sponsor ID
- GEN-003-005
- Conditions
- Genital Herpes, HSV-2 Infection
- Keywords
- HSV, Herpes, Genital Herpes, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 2017 business decision to cease GEN-003 spending.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Genocea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.
Detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial of GEN-003 in subjects who have received previous doses of GEN-003 in the GEN-003-003 clinical trial. Eligible subjects will be randomized in a 1:1 ratio to receive 1 intramuscular (IM) dose (the maintenance dose) of GEN-003 or placebo.
Subjects will use a daily electronic reporting tool for reporting the presence or absence of genital herpes lesions, and severity of genital herpes symptoms.
GEN-003-005 was originally designed to follow subjects for 12 months after the maintenance dose but a business decision, unrelated to product safety, was made by Genocea Biosciences in 3Q2017 to cease GEN-003 spending and activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GEN-003 | Experimental | Biological: GEN-003, Biological: Matrix-M260μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection |
| Placebo | Placebo comparator | Other: 0.9% normal saline0.9% normal saline administered as a 0.5mL intramuscular (IM) injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Completed Study GEN-003-003
- Received all 3 GEN-003 doses (any dose combination) in Study GEN-003-003
- Received last dose of GEN-003 within 11 to 18 months prior
- Reported data in the daily electronic reporting period on at least 80% of days in Study GEN-003-003
- Collected at least 45 swabs (of 56 total expected swabs) during the Month 11 to 12 swab collection period in Study GEN-003-003
Key exclusion criteria (20 listed)
- Did not meet all eligibility criteria in Study GEN-003-003, or received incorrect treatment in Study GEN-003-003
- Use of suppressive antiviral medication within 14 days prior
- Use of topical steroids or antiviral medication in the anogenital region within 14 days prior
- Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV recurrence frequency or intensity within 14 days prior
- History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis
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 |
|---|---|---|
| GEN-003Also: HSV Therapeutic VaccineHSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D | Biological | GEN-003 |
| Matrix-M2Also: AdjuvantMatrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol. | Biological | GEN-003 |
| 0.9% normal salinePlacebo | Other | Placebo |
Primary outcome
Percentage of Days With Genital Herpes Lesions
Time frame: The 6-month period after vaccination
Subject-reported via electronic diary
4 secondary outcomes
Number of Genital Herpes Recurrences
Time frame: The 6-month period after vaccination
Number of Subjects Without Genital Herpes Recurrence
Time frame: 6 months after vaccination
Days Until First Genital Herpes Recurrence
Time frame: The 6-month period after vaccination
Duration of Genital Herpes Recurrences
Time frame: The 6-month period after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 GEN-003, Matrix-M2 and 0.9% normal saline in people with Genital Herpes and HSV-2 Infection, run by Genocea Biosciences, Inc. at 8 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 8 inclusion and 20 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: stopped early, as of the sponsor's last update on 19 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 8 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?
Yes. Results are posted in the registry (first posted 19 Feb 2019). 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?
Percentage of Days With Genital Herpes Lesions (time frame: The 6-month period after vaccination). 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 19 Feb 2019.