Genital Herpes Simplex Type 2Phase 1/2NCT01667341
Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine
A Phase 1/2 study testing GEN-003 with Matrix M-2 and GEN-003 in people with Genital Herpes Simplex Type 2, run by Genocea Biosciences, Inc. at 7 sites in United States.
Trial summary
Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each cohort, patients will be randomized at a ratio of 3:1:1 to one of the following: 1. 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 with Matrix M-2 and GEN-003
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2012to 9 May 2014
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Men and women ages 18 to 50 years, inclusive.
- Willing to practice a highly effective method of contraception that includes the use of a barrier method such as a condom.
- 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 HSV-2 ELISA (HerpSelect) index value >3.5
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- 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 suppressive therapy.
- Good general health status as determined by screening evaluation completed within 90 days prior to immunization. Any out of range screening clinical laboratory values should be considered not clinically significant by the Investigator.
- Patient has provided written informed consent.
- Ability and willingness to perform and comply with all study procedures including attending clinic visits as scheduled. Note: patients must provide, by the day of randomization, a minimum of 28 (equivalent of 14 days) baseline viral swab samples to continue to be eligible and be randomized).
Who cannot join
- On suppressive antiviral medication within 7 days of baseline viral shedding evaluation.
- Immunocompromised individuals, including those receiving systemic corticosteroids or other immunosuppressive agents.
- Positive serologic test for HIV-1 infection; positive hepatitis B surface antigen (HBsAg) or antibody for hepatitis C (anti-HCV).
- Active lesions consistent with herpetic disease at the time of scheduled immunization.
- Pregnant or nursing women.
- Receipt of any investigational drug within 30 days of the first scheduled day of immunization.
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- History of hypersensitivity to any component of the vaccine.
- History of genital HSV-1 infection.
- History of: (1) any form of ocular HSV infection, (2) HSV-related erythema multiforme, or (3) herpes meningitis or encephalitis.
- Any other condition which in the opinion of the Investigator would interfere with the successful completion of the study protocol.
- 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.
- Prior immunization with a vaccine containing HSV-2 antigens.
- Receipt of blood products within 90 days of the first immunization.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama Vaccine Research Unit
Birmingham, Alabama, 35294-0006
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Center for Clinical Studies - Houston
Houston, Texas, 77030
Indiana University Infectious Disease Research
Indianapolis, Indiana, 46202
Westover Heights Clinic
Portland, Oregon, 97210
UW Virology Research Clinic
Seattle, Washington, 98104
Center for Clinical Studies - Clear Lake/Webster
Webster, Texas, 77598
About this study
Official title: A Phase I/IIa, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study of the Safety and Immunogenicity of a HSV-2 Vaccine Containing Matrix M-2 Adjuvant in Individuals With Documented Genital HSV-2 Genital Infection
Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each cohort, patients will be randomized at a ratio of 3:1:1 to one of the following:
- GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose)
- GEN-003: Antigens alone
- Placebo (DPBS diluent)
Read more
Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot Group. Immunization of the remainder of the Group "Continuation Group") is contingent upon successful review of data from the Pilot Group through Day 7 after immunization. Dose escalation to the next dose level Cohort proceeds after evaluation of safety data from all patients in the prior Cohort and only after all specified safety criteria are met. The total numbers of patients in each Group and Cohort are as follows:
- 10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
- 30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
- 100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
- Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients)
Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at 3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done twice daily for 28 days prior to the first immunization (baseline shedding), and again following the last immunization. Follow-up for safety monitoring will be conducted for 12 months after the last immunization.
- Conditions
- Genital Herpes Simplex Type 2
- Being tested
- GEN-003 with Matrix M-2, GEN-003, Placebo
- 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 with Matrix M-2Biological
IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
GEN-003Biological
IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
PlaceboBiological
Also called PBS, DPBS
IM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose GEN-003 with Matrix M-2 | Experimental | 10µg GEN-003, 50µg Matrix M-2 Adjuvant Receives: Biological: GEN-003 with Matrix M-2 |
| Mid Dose GEN-003 with Matrix M-2 | Experimental | 30µg GEN-003, 50µg Matrix M-2 Adjuvant Receives: Biological: GEN-003 with Matrix M-2 |
| High Dose GEN-003 with Matrix M-2 | Experimental | 100µg GEN-003, 50µg Matrix M-2 Adjuvant Receives: Biological: GEN-003 with Matrix M-2 |
| Low Dose GEN-003 Only | Experimental | 10µg GEN-003 Receives: Biological: GEN-003 |
| Mid Dose GEN-003 Only | Experimental | 30µg GEN-003 Receives: Biological: GEN-003 |
| High Dose GEN-003 Only | Experimental | 100µg GEN-003 Receives: Biological: GEN-003 |
| Placebo | Placebo comparator | 0.5 mL phosphate buffered saline Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events as a measure of safety and tolerability
Measured: 57 Weeks
Secondary outcomes (2)
Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens
Measured: 33 weeks
Change in proportion of days with detectable viral shedding
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startJul 2012
- Primary completion9 May 2014
- Study completion9 May 2014
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 143 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
- NCT01667341
- Sponsor's protocol ID
- GEN-003-001
- Status last verified
- May 2018
- First submitted
- 14 Aug 2012
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bernstein DI, Wald A, Warren T, Fife K, Tyring S, Lee P, Van Wagoner N, Magaret A, Flechtner JB, Tasker S, Chan J, Morris A, Hetherington S. Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial. J Infect Dis. 2017 Mar 15;215(6):856-864. doi: 10.1093/infdis/jix004.
PubMed 28329211
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study of the Safety and Immunogenicity of a HSV-2 Vaccine Containing Matrix M-2 Adjuvant in Individuals With Documented Genital HSV-2 Genital Infection
- ClinicalTrials.gov ID
- NCT01667341
- Acronym / sponsor ID
- GEN-003-001
- Conditions
- Genital Herpes Simplex Type 2
- Keywords
- HSV, Herpes, genital infection, vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Genocea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- 9 May 2014 (actual)
- Study completion
- 9 May 2014 (actual)
- First posted
- 17 Aug 2012 (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.
Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each cohort, patients will be randomized at a ratio of 3:1:1 to one of the following:
- GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose)
- GEN-003: Antigens alone
- Placebo (DPBS diluent)
Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot Group. Immunization of the remainder of the Group "Continuation Group") is contingent upon successful review of data from the Pilot Group through Day 7 after immunization. Dose escalation to the next dose level Cohort proceeds after evaluation of safety data from all patients in the prior Cohort and only after all specified safety criteria are met. The total numbers of patients in each Group and Cohort are as follows:
- 10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
- 30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
- 100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
- Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients)
Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at 3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done twice daily for 28 days prior to the first immunization (baseline shedding), and again following the last immunization. Follow-up for safety monitoring will be conducted for 12 months after the last immunization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Low Dose GEN-003 with Matrix M-2 | Experimental | Biological: GEN-003 with Matrix M-210µg GEN-003, 50µg Matrix M-2 Adjuvant |
| Mid Dose GEN-003 with Matrix M-2 | Experimental | Biological: GEN-003 with Matrix M-230µg GEN-003, 50µg Matrix M-2 Adjuvant |
| High Dose GEN-003 with Matrix M-2 | Experimental | Biological: GEN-003 with Matrix M-2100µg GEN-003, 50µg Matrix M-2 Adjuvant |
| Low Dose GEN-003 Only | Experimental | Biological: GEN-00310µg GEN-003 |
| Mid Dose GEN-003 Only | Experimental | Biological: GEN-00330µg GEN-003 |
| High Dose GEN-003 Only | Experimental | Biological: GEN-003100µg GEN-003 |
| Placebo | Placebo comparator | Biological: Placebo0.5 mL phosphate buffered saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Men and women ages 18 to 50 years, inclusive.
- Willing to practice a highly effective method of contraception that includes the use of a barrier method such as a condom.
- Diagnosis of genital HSV-2 infection for > 1 year supported by ONE of the following documented in the medical history or performed at screening:
- 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 suppressive therapy.
- Good general health status as determined by screening evaluation completed within 90 days prior to immunization. Any out of range screening clinical laboratory values should be considered not clinically significant by the Investigator.
Key exclusion criteria (13 listed)
- On suppressive antiviral medication within 7 days of baseline viral shedding evaluation.
- Immunocompromised individuals, including those receiving systemic corticosteroids or other immunosuppressive agents.
- Positive serologic test for HIV-1 infection; positive hepatitis B surface antigen (HBsAg) or antibody for hepatitis C (anti-HCV).
- Active lesions consistent with herpetic disease at the time of scheduled immunization.
- Pregnant or nursing women.
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 with Matrix M-2IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant. | Biological | High Dose GEN-003 with Matrix M-2, Low Dose GEN-003 with Matrix M-2, Mid Dose GEN-003 with Matrix M-2 |
| GEN-003IM administration of GEN-003 Vaccine, antigens alone (without adjuvant). | Biological | High Dose GEN-003 Only, Low Dose GEN-003 Only, Mid Dose GEN-003 Only |
| PlaceboAlso: PBS, DPBSIM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline. | Biological | Placebo |
Primary outcome
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 57 Weeks
2 secondary outcomes
Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens
Time frame: 33 weeks
Change in proportion of days with detectable viral shedding
Time frame: 6 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 1 Jun 2018.
- Derived from this study: PubMed 28329211Bernstein DI, Wald A, Warren T, Fife K, Tyring S, Lee P, Van Wagoner N, Magaret A, Flechtner JB, Tasker S, Chan J, Morris A, Hetherington S. Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial. J Infect Dis. 2017 Mar 15;215(6):856-864. doi: 10.1093/infdis/jix004.
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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.
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 GEN-003 with Matrix M-2 and GEN-003 in people with Genital Herpes Simplex Type 2, run by Genocea Biosciences, Inc. 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 10 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 1 Jun 2018. 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 patients with adverse events as a measure of safety and tolerability (time frame: 57 Weeks). 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 NCT01667341, 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 1 Jun 2018.