Genital Herpes Simplex Type 2Phase 2NCT02515175
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
A Phase 2 study testing Matrix-M2 and GEN-003 in people with Genital Herpes Simplex Type 2, run by Genocea Biosciences, Inc. at 8 sites in United States.
Trial summary
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Genital Herpes Simplex Type 2
- What is being tested?
- Matrix-M2 and GEN-003
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2015to 25 May 2017
- 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
- No healthy volunteers
- Adult
Who may be able to join
- A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive antiviral therapy, a history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of antiviral suppressive therapy
- Diagnosis of genital HSV-2 infection for > 1 year
- Willing and able to provide written informed consent
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled and completion of an electronic lesion report form
- Willing to not use suppressive antiviral therapy from 14 days prior to starting the study and for the duration of the study
- Men and women must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, tubal ligation, hysterectomy, licensed hormonal methods, intrauterine device, or barrier method (e.g., condom, diaphragm) with spermicide for 28 days before and 90 days after receiving the Study Drug
Who cannot join
- On suppressive antiviral therapy within 14 days of starting the study
- Use of topical steroids or antiviral medication in the anogenital region within 14 days of starting the study and during study
- Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days of starting the study
- History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis
- Immunocompromised individuals
- Use of corticosteroids within 30 days of starting the study and during the study or other immunosuppressive agents
Show all 16Show fewer
- Presence or history of autoimmune disease regardless of current treatment
- Current infection with HIV or hepatitis B or C virus
- History of hypersensitivity to any component of the vaccine
- Prior receipt of GEN-003 or another vaccine containing HSV-2 antigens
- Receipt of any investigational product within 30 days prior to Dose 1
- Receipt of blood products within 90 days prior to Dose 1
- Planned use of any vaccine over the course of the study
- Pregnant or nursing women
- History of drug or alcohol abuse
- Other active, uncontrolled comorbidities
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
The Fenway Institute
Boston, Massachusetts, 02215
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229
Medical Center for Clinical Research
San Diego, California, 92108
Quest Clinical Research
San Francisco, California, 94115
University of Washington
Seattle, Washington, 98104
About this study
Official title: A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection.
Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals then complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each subject will be followed for one year after the third dose.
- Conditions
- Genital Herpes Simplex Type 2
- Being tested
- Matrix-M2, GEN-003, Placebo
- Keywords
- HSV, Herpes, Genital Herpes, Vaccine
- Medical subject headings
- Herpes Simplex, Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix-M2Biological
Also called Adjuvant
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
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 ICP and glycoprotein D
PlaceboDrug
Also called 0.9% Normal Saline
0.9% Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| GEN-003 60ug / Matrix-M2 50ug | Experimental | GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection Receives: Biological: Matrix-M2; Biological: GEN-003 |
| GEN-003 60ug / Matrix-M2 75ug | Experimental | GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection Receives: Biological: Matrix-M2; Biological: GEN-003 |
| Placebo | Placebo comparator | 0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HSV-2 viral shedding rate
Measured: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)
Secondary outcomes (6)
Immunogenicity measured by humoral (antibody) responses to vaccine antigens
Measured: 13 weeks
Impact on clinical HSV-2 disease based on time to first recurrence
Measured: 64 weeks
Number of patients with adverse events as a measure of safety and tolerability
Measured: 64 weeks
Reduction in HSV-2 viral shedding rate
Measured: After vaccination (6 Months and 12 Months)
Impact on clinical HSV-2 disease based on lesion rate
Measured: 64 weeks
Impact on clinical HSV-2 disease based on percent recurrence-free
Measured: 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 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
- NCT02515175
- Sponsor's protocol ID
- GEN-003-003
- Status last verified
- May 2018
- First submitted
- 31 Jul 2015
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bernstein DI, Flechtner JB, McNeil LK, Heineman T, Oliphant T, Tasker S, Wald A, Hetherington S; Genocea study group. Therapeutic HSV-2 vaccine decreases recurrent virus shedding and recurrent genital herpes disease. Vaccine. 2019 Jun 6;37(26):3443-3450. doi: 10.1016/j.vaccine.2019.05.009. Epub 2019 May 15.
PubMed 31103365
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection
- ClinicalTrials.gov ID
- NCT02515175
- Acronym / sponsor ID
- GEN-003-003
- Conditions
- Genital Herpes Simplex Type 2
- Keywords
- HSV, Herpes, Genital Herpes, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Genocea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 4 Aug 2015 (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.
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
Detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection.
Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals then complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each subject will be followed for one year after the third dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GEN-003 60ug / Matrix-M2 50ug | Experimental | Biological: Matrix-M2, Biological: GEN-003GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection |
| GEN-003 60ug / Matrix-M2 75ug | Experimental | Biological: Matrix-M2, Biological: GEN-003GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection |
| Placebo | Placebo comparator | Drug: Placebo0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive antiviral therapy, a history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of antiviral suppressive therapy
- Diagnosis of genital HSV-2 infection for > 1 year
- Willing and able to provide written informed consent
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled and completion of an electronic lesion report form
- Willing to not use suppressive antiviral therapy from 14 days prior to starting the study and for the duration of the study
Key exclusion criteria (16 listed)
- On suppressive antiviral therapy within 14 days of starting the study
- Use of topical steroids or antiviral medication in the anogenital region within 14 days of starting the study and during study
- Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days of starting the study
- History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis
- Immunocompromised individuals
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 |
|---|---|---|
| Matrix-M2Also: AdjuvantMatrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol. | Biological | GEN-003 60ug / Matrix-M2 50ug, GEN-003 60ug / Matrix-M2 75ug |
| GEN-003Also: HSV Therapeutic VaccineHSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D | Biological | GEN-003 60ug / Matrix-M2 50ug, GEN-003 60ug / Matrix-M2 75ug |
| PlaceboAlso: 0.9% Normal Saline0.9% Normal Saline | Drug | Placebo |
Primary outcome
Change in HSV-2 viral shedding rate
Time frame: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)
6 secondary outcomes
Immunogenicity measured by humoral (antibody) responses to vaccine antigens
Time frame: 13 weeks
Impact on clinical HSV-2 disease based on time to first recurrence
Time frame: 64 weeks
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 64 weeks
Reduction in HSV-2 viral shedding rate
Time frame: After vaccination (6 Months and 12 Months)
Impact on clinical HSV-2 disease based on lesion rate
Time frame: 64 weeks
Impact on clinical HSV-2 disease based on percent recurrence-free
Time frame: 64 weeks
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 22 May 2018.
- Derived from this study: PubMed 31103365Bernstein DI, Flechtner JB, McNeil LK, Heineman T, Oliphant T, Tasker S, Wald A, Hetherington S; Genocea study group. Therapeutic HSV-2 vaccine decreases recurrent virus shedding and recurrent genital herpes disease. Vaccine. 2019 Jun 6;37(26):3443-3450. doi: 10.1016/j.vaccine.2019.05.009. Epub 2019 May 15.
- Individual participant dataSharing planned: Undecided
Related trials for Genital Herpes Simplex Type 2
Active, not recruitingPhase 1
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.
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 Matrix-M2 and GEN-003 in people with Genital Herpes Simplex Type 2, 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 6 inclusion and 16 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 22 May 2018. 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?
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?
Change in HSV-2 viral shedding rate (time frame: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515175, which also lists 1 linked publication.
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 22 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.