Genital Herpes Simplex Type 2Phase 2NCT02114060
Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
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 randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant. 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?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 16 sitesUnited States
- Study dates
- Jul 2014to Feb 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
- Males and non-pregnant females, ages 18 to 50 years inclusive.
- Diagnosis of genital HSV-2 infection for > 1 year supported by ONE of the following documented in the medical history or performed at screening:
- Western blot for HSV-2
- Type-specific polymerase chain reaction (PCR) or viral culture
- Compatible clinical history AND
- Positive HerpeSelect® 2 Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G (IgG) with an index value >3.5, or
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- Positive LIAISON® HSV-2 Type-Specific IgG
- A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive therapy, history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of suppressive therapy.
- Collection of at least 45 of 56 anogenital swabs during the baseline period.
- 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 of beginning baseline anogenital swab collection period.
- History of genital Herpes Simplex Virus type-1 (HSV-1) infection.
- 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; positive hepatitis B surface antigen (HBsAg).
Show all 16Show fewer
- Clinically significant laboratory abnormality or a value ≥ Grade 2.
- Prior immunization with a vaccine containing HSV-2 antigens.
- History of hypersensitivity to any component of the vaccine.
- Receipt of any investigational drug within 30 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: A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2 Infection
This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant.
Secondary objectives of the study include:
Read more
- Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo.
- Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:
- Time to first clinical and/or virologic recurrence,
- 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 swabbing periods.
- Evaluation of cellular and humoral responses to GEN-003 antigens.
Additional objectives include:
- Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above.
- Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study.
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. Subjects will be followed for safety and immunologic response for 12 months following their last dose.
- 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.
PlaceboBiological
Also called 0.9% Normal Saline (NaCl)
0.9% Normal Saline (NaCl)
| 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) |
| Placebo | Placebo comparator | 0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of days with detectable viral shedding
Measured: 6 weeks
Secondary outcomes (3)
Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens
Measured: 33 weeks
Impact on clinical HSV-2 disease based on time to recurrence and lesion rate
Measured: 53 weeks
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 posted15 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2016
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 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
- NCT02114060
- Sponsor's protocol ID
- GEN-003-002
- Status last verified
- Oct 2017
- First submitted
- 11 Apr 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
- A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2 Infection
- ClinicalTrials.gov ID
- NCT02114060
- Acronym / sponsor ID
- GEN-003-002
- Conditions
- Genital Herpes Simplex Type 2
- Keywords
- HSV, Herpes, genital infection, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Genocea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Apr 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 randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant.
Secondary objectives of the study include:
- Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo.
- Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:
- Time to first clinical and/or virologic recurrence,
- 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 swabbing periods.
- Evaluation of cellular and humoral responses to GEN-003 antigens.
Additional objectives include:
- Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above.
- Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study.
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. Subjects will be followed for safety and immunologic response for 12 months following their last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| 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. |
| Placebo | Placebo comparator | Biological: 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 (12 listed)
- Males and non-pregnant females, ages 18 to 50 years inclusive.
- Diagnosis of genital HSV-2 infection for > 1 year supported by ONE of the following documented in the medical history or performed at screening:
- Positive HerpeSelect® 2 Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G (IgG) with an index value >3.5, or
- Positive LIAISON® HSV-2 Type-Specific IgG
- A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive therapy, history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of suppressive therapy.
Key exclusion criteria (16 listed)
- On suppressive antiviral medication within 7 days of beginning baseline anogenital swab collection period.
- History of genital Herpes Simplex Virus type-1 (HSV-1) infection.
- 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 |
| PlaceboAlso: 0.9% Normal Saline (NaCl)0.9% Normal Saline (NaCl) | Biological | Placebo |
Primary outcome
Change in proportion of days with detectable viral shedding
Time frame: 6 weeks
3 secondary outcomes
Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens
Time frame: 33 weeks
Impact on clinical HSV-2 disease based on time to recurrence and lesion rate
Time frame: 53 weeks
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.
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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.
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 12 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 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. 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 proportion of days with detectable viral shedding (time frame: 6 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.