Genital Herpes Simplex Type 2Phase 2NCT02300142
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
A Phase 2 study testing GEN-003 Vaccine (30μg of each antigen), GEN-003 Vaccine (60μg of each antigen) and Matrix-M2 Adjuvant (25μg) in people with Genital Herpes Simplex Type 2, run by Genocea Biosciences, Inc. at 16 sites in United States.
Trial summary
This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. 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?
- GEN-003 Vaccine (30μg of each antigen), GEN-003 Vaccine (60μg of each antigen) and Matrix-M2 Adjuvant (25μg)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 16 sitesUnited States
- Study dates
- Jan 2015to Jun 2016
- 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
- Subjects who received placebo in GEN-003-002 and completed the study through Day 71 per protocol, including the collection of at least 45 anogenital swabs during Days 43 to 71.
- Enrolled into this trial within 56 days of completing Day 71 of GEN-003-002.
- Willing and able to provide written informed consent.
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
- Men and women of childbearing potential, must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, vasectomy, licensed hormonal methods, intrauterine device (IUD), or barrier method (e.g., condom, diaphragm) for 28 days before and 90 days after receiving Study Drug.
Who cannot join
- On suppressive antiviral medication within 7 days prior to the first dose of Study Drug.
- Collection of less than 45 anogenital swabs during Days 43 to 71 of the GEN-003-002 study.
- History of any form of ocular Herpes Simplex Virus (HSV) infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis.
- Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior to the first dose of Study Drug, any dose of corticosteroids within 30 days of the first dose of Study Drug, or high dose inhaled corticosteroids [> 960 μg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
- Presence or history of autoimmune disease, regardless of current treatment.
- Positive serologic test for Human Immunodeficiency Virus (HIV-1) or hepatitis C infection (in the absence of a negative PCR result); positive hepatitis B surface antigen (HBsAg) within 6 months prior to the first dose of Study Drug.
Show all 13Show fewer
- Clinically significant laboratory abnormality or a value ≥ Grade 2 within 56 days prior to the first dose of Study Drug.
- Receipt of blood products within 90 days prior to the first dose of Study Drug.
- Receipt of a live vaccine within 28 days prior to or a subunit vaccine within 14 days prior to the first dose of Study Drug or planned vaccination within 30 days following the last dose of Study Drug.
- Pregnant or nursing women.
- History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study.
- Other active, uncontrolled co-morbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.
- NOTE: Subjects who are taking a medication to control an underlying co-morbidity may be enrolled if there have been no changes to their medication within 60 days prior to the first dose of Study Drug.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Tekton Research
Austin, Texas, 98745
University of Alabama Vaccine Research Unit
Birmingham, Alabama, 35294-0006
The Fenway Institute
Boston, Massachusetts, 02215
UNC Global HIV Prevention and Treatment Clinical Trials Unit
Chapel Hill, North Carolina, 27599
University of Illinois Department of Medicine
Chicago, Illinois, 60612
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Center for Clinical Studies - Houston
Houston, Texas, 77030
Center for Clinical Studies
Houston, Texas, 77065
Indiana University Infectious Disease Research
Indianapolis, Indiana, 46202
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Westover Heights Clinic
Portland, Oregon, 97210
University of Utah
Salt Lake City, Utah, 84132
Medical Center for Clinical Research
San Diego, California, 92108
Quest Clinical Research
San Francisco, California, 94115
UW Virology Research Clinic
Seattle, Washington, 98104
Center for Clinical Studies - Clear Lake/Webster
Webster, Texas, 77598
About this study
Official title: Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 - Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2
This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2.
Objectives:
- To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:
- Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)
- Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine
- Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period
- Antiviral use.
- To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.
- Conditions
- Genital Herpes Simplex Type 2
- Being tested
- GEN-003 Vaccine (30μg of each antigen), GEN-003 Vaccine (60μg of each antigen), Matrix-M2 Adjuvant (25μg), Matrix-M2 Adjuvant (50μg), Matrix-M2 Adjuvant (75μg)
- Keywords
- HSV, Herpes, genital infection, vaccine
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN-003 Vaccine (30μg of each antigen)Biological
Also called HSV 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
GEN-003 Vaccine (60μg of each antigen)Biological
Also called HSV 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
Matrix-M2 Adjuvant (25μg)Biological
Also called MM2, Adjuvant
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Matrix-M2 Adjuvant (50μg)Biological
Also called MM2, Adjuvant
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Matrix-M2 Adjuvant (75μg)Biological
Also called MM2, Adjuvant
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
| Study group | Role | What they receive |
|---|---|---|
| GEN-003 Vaccine 30μg / Matrix-M 25μg | Experimental | GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection. Receives: Biological: GEN-003 Vaccine (30μg of each antigen); Biological: Matrix-M2 Adjuvant (25μg) |
| GEN-003 Vaccine 30μg / Matrix-M2 50μg | Experimental | GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection. Receives: Biological: GEN-003 Vaccine (30μg of each antigen); Biological: Matrix-M2 Adjuvant (50μg) |
| GEN-003 Vaccine 30μg / Matrix-M2 75μg | Experimental | GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection. Receives: Biological: GEN-003 Vaccine (30μg of each antigen); Biological: Matrix-M2 Adjuvant (75μg) |
| GEN-003 Vaccine 60μg / Matrix-M2 25μg | Experimental | GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection. Receives: Biological: GEN-003 Vaccine (60μg of each antigen); Biological: Matrix-M2 Adjuvant (25μg) |
| GEN-003 Vaccine 60μg / Matrix-M2 50μg | Experimental | GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection. Receives: Biological: GEN-003 Vaccine (60μg of each antigen); Biological: Matrix-M2 Adjuvant (50μg) |
| GEN-003 Vaccine 60μg / Matrix-M2 75μg | Experimental | GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection. Receives: Biological: GEN-003 Vaccine (60μg of each antigen); Biological: Matrix-M2 Adjuvant (75μg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on clinical HSV-2 disease based on time to recurrence and lesion rate
Measured: 53 weeks
Secondary outcomes (1)
Number of patients with adverse events as a measure of safety and tolerability
Measured: 57 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 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
- NCT02300142
- Sponsor's protocol ID
- GEN-003-002a
- Status last verified
- Oct 2017
- First submitted
- 20 Nov 2014
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 - Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2
- ClinicalTrials.gov ID
- NCT02300142
- Acronym / sponsor ID
- GEN-003-002a
- Conditions
- Genital Herpes Simplex Type 2
- Keywords
- HSV, Herpes, genital infection, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Genocea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Nov 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.
This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2.
Objectives:
- To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:
- Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)
- Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine
- Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period
- Antiviral use.
- To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GEN-003 Vaccine 30μg / Matrix-M 25μg | Experimental | Biological: GEN-003 Vaccine (30μg of each antigen), Biological: Matrix-M2 Adjuvant (25μg)GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection. |
| GEN-003 Vaccine 30μg / Matrix-M2 50μg | Experimental | Biological: GEN-003 Vaccine (30μg of each antigen), Biological: Matrix-M2 Adjuvant (50μg)GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection. |
| GEN-003 Vaccine 30μg / Matrix-M2 75μg | Experimental | Biological: GEN-003 Vaccine (30μg of each antigen), Biological: Matrix-M2 Adjuvant (75μg)GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection. |
| GEN-003 Vaccine 60μg / Matrix-M2 25μg | Experimental | Biological: GEN-003 Vaccine (60μg of each antigen), Biological: Matrix-M2 Adjuvant (25μg)GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection. |
| GEN-003 Vaccine 60μg / Matrix-M2 50μg | Experimental | Biological: GEN-003 Vaccine (60μg of each antigen), Biological: Matrix-M2 Adjuvant (50μg)GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection. |
| GEN-003 Vaccine 60μg / Matrix-M2 75μg | Experimental | Biological: GEN-003 Vaccine (60μg of each antigen), Biological: Matrix-M2 Adjuvant (75μg)GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (75 μg), 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 (5 listed)
- Subjects who received placebo in GEN-003-002 and completed the study through Day 71 per protocol, including the collection of at least 45 anogenital swabs during Days 43 to 71.
- Enrolled into this trial within 56 days of completing Day 71 of GEN-003-002.
- Willing and able to provide written informed consent.
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
- Men and women of childbearing potential, must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, vasectomy, licensed hormonal methods, intrauterine device (IUD), or barrier method (e.g., condom, diaphragm) for 28 days before and 90 days after receiving Study Drug.
Key exclusion criteria (13 listed)
- On suppressive antiviral medication within 7 days prior to the first dose of Study Drug.
- Collection of less than 45 anogenital swabs during Days 43 to 71 of the GEN-003-002 study.
- History of any form of ocular Herpes Simplex Virus (HSV) infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis.
- Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior to the first dose of Study Drug, any dose of corticosteroids within 30 days of the first dose of Study Drug, or high dose inhaled corticosteroids [> 960 μg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
- Presence or history of autoimmune disease, regardless of current treatment.
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-003 Vaccine (30μg of each antigen)Also: HSV 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 Vaccine 30μg / Matrix-M 25μg, GEN-003 Vaccine 30μg / Matrix-M2 50μg, GEN-003 Vaccine 30μg / Matrix-M2 75μg |
| GEN-003 Vaccine (60μg of each antigen)Also: HSV 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 Vaccine 60μg / Matrix-M2 25μg, GEN-003 Vaccine 60μg / Matrix-M2 50μg, GEN-003 Vaccine 60μg / Matrix-M2 75μg |
| Matrix-M2 Adjuvant (25μg)Also: MM2, AdjuvantMatrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol. | Biological | GEN-003 Vaccine 30μg / Matrix-M 25μg, GEN-003 Vaccine 60μg / Matrix-M2 25μg |
| Matrix-M2 Adjuvant (50μg)Also: MM2, AdjuvantMatrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol. | Biological | GEN-003 Vaccine 30μg / Matrix-M2 50μg, GEN-003 Vaccine 60μg / Matrix-M2 50μg |
| Matrix-M2 Adjuvant (75μg)Also: MM2, AdjuvantMatrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol. | Biological | GEN-003 Vaccine 30μg / Matrix-M2 75μg, GEN-003 Vaccine 60μg / Matrix-M2 75μg |
Primary outcome
Impact on clinical HSV-2 disease based on time to recurrence and lesion rate
Time frame: 53 weeks
1 secondary outcome
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 57 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 16 Oct 2017.
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.
16 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 Vaccine (30μg of each antigen), GEN-003 Vaccine (60μg of each antigen) and Matrix-M2 Adjuvant (25μg) in people with Genital Herpes Simplex Type 2, run by Genocea Biosciences, Inc. at 16 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 5 inclusion and 13 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 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. 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?
Impact on clinical HSV-2 disease based on time to recurrence and lesion rate (time frame: 53 weeks). 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 16 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.