Genital Herpes Simplex Type 2NCT02910284
Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity
An observational study of Genital Herpes Simplex Type 2, run by Genocea Biosciences, Inc. at 13 sites in United States.
Trial summary
This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and immunogenicity of GEN-003 in subjects with genital HSV-2 infection. 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?
- Observational
- How many people
- 140 participants
- Where
- 13 sitesUnited States
- Study dates
- 16 Sep 2016to 14 Jul 2017
- Phase
- Observational
- 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
Study population: Subjects who received at least 1 dose of active GEN-003 and completed the GEN-003-002 study.
Who may be able to join
- Completion of Study GEN-003-002
- Receipt of at least 1 dose of GEN-003 (any dose combination) in Study GEN-003-002.
- Collection of at least 45 of 56 anogenital swabs during the Month 11 to 12 swab collection period in Study 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.
- For each swab collection period, willing to not use HSV-2 antiviral therapy from 14 days before the swab collection period through the end of the period.
Who cannot join
- Any important protocol deviation in Study GEN-003-002.
- Use of HSV-2 antiviral therapy within 14 days before the beginning of Swab Collection Period 1.
- Use of topical steroids or antiviral medication in the anogenital region within 14 days before the beginning of Swab Collection Period 1.
- Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days before the beginning of Swab Collection Period 1.
- 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 before the Visit 1, any dose of corticosteroids within 30 days before Visit 1, or high-dose inhaled corticosteroids [>960 µg/day of beclomethasone diproprionate or equivalent]) or other immunosuppressive agents.
- Presence or history of autoimmune disease, regardless of current treatment.
Show all 11Show fewer
- Receipt of a vaccine containing HSV-2 antigens other than GEN-003.
- Pregnant 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.
- Onset of an AESI since Month 12 in study GEN-003-002.
- Other active, uncontrolled comorbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 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, North Carolina, 27599
University of Illinois - Chicago
Chicago, Illinois, 60612
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Center for Clinical Studies
Houston, Texas, 77004
Indiana University
Indianapolis, Indiana, 46202
Magee - Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
NW Dermatology and Research
Portland, Oregon, 97210
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 Long-term Follow-up Study of Efficacy and Immunogenicity of GEN-003 in Subjects With Genital Herpes Simplex Virus Type 2 (HSV-2) Infection
This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and immunogenicity of GEN-003 in subjects with genital HSV-2 infection.
- Conditions
- Genital Herpes Simplex Type 2
- Being tested
- Observational
- Keywords
- HSV, Herpes, Genital Herpes
- 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.
ObservationalBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (percent of anogenital swabs positive for HSV-2 DNA by PCR)
Measured: Up to 48 months post-dose
Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (magnitude of HSV-2 viral shedding by PCR)
Measured: Up to 48 months post-dose
Secondary outcomes (4)
Long-term effect of GEN-003 on HSV-lesion rate (percent of days with genital lesions present) during the swab collection periods
Measured: Up to 48 months post-dose
Long-term immune responses to GEN-003 (Serum IgG levels assessed by ELISA)
Measured: Up to 48 months post-dose
Long-term immune responses to GEN-003 (Serum HSV-2 neutralizing antibody levels assessed by a colorimetric neutralization assay)
Measured: Up to 48 months post-dose
Long-term immune responses to GEN-003 (Spot-forming units (SFUs), fold rise, responder rate assessed by GrB ELISPOT)
Measured: Up to 48 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start16 Sep 2016
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 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
- NCT02910284
- Sponsor's protocol ID
- GEN-003-002b
- Status last verified
- Oct 2017
- First submitted
- 9 Sep 2016
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-up Study of Efficacy and Immunogenicity of GEN-003 in Subjects With Genital Herpes Simplex Virus Type 2 (HSV-2) Infection
- ClinicalTrials.gov ID
- NCT02910284
- Acronym / sponsor ID
- GEN-003-002b
- Conditions
- Genital Herpes Simplex Type 2
- Keywords
- HSV, Herpes, Genital Herpes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Genocea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2016 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 22 Sep 2016 (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 is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and immunogenicity of GEN-003 in subjects with genital HSV-2 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects who received at least 1 dose of active GEN-003 and completed the GEN-003-002 study.
Key inclusion criteria (6 listed)
- Completion of Study GEN-003-002
- Receipt of at least 1 dose of GEN-003 (any dose combination) in Study GEN-003-002.
- Collection of at least 45 of 56 anogenital swabs during the Month 11 to 12 swab collection period in Study 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.
Key exclusion criteria (11 listed)
- Any important protocol deviation in Study GEN-003-002.
- Use of HSV-2 antiviral therapy within 14 days before the beginning of Swab Collection Period 1.
- Use of topical steroids or antiviral medication in the anogenital region within 14 days before the beginning of Swab Collection Period 1.
- Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days before the beginning of Swab Collection Period 1.
- 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 before the Visit 1, any dose of corticosteroids within 30 days before Visit 1, or high-dose inhaled corticosteroids [>960 µg/day of beclomethasone diproprionate or equivalent]) or other immunosuppressive agents.
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 |
|---|---|---|
| Observational | Biological | – |
Primary outcome
Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (percent of anogenital swabs positive for HSV-2 DNA by PCR)
Time frame: Up to 48 months post-dose
Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (magnitude of HSV-2 viral shedding by PCR)
Time frame: Up to 48 months post-dose
4 secondary outcomes
Long-term effect of GEN-003 on HSV-lesion rate (percent of days with genital lesions present) during the swab collection periods
Time frame: Up to 48 months post-dose
Long-term immune responses to GEN-003 (Serum IgG levels assessed by ELISA)
Time frame: Up to 48 months post-dose
Long-term immune responses to GEN-003 (Serum HSV-2 neutralizing antibody levels assessed by a colorimetric neutralization assay)
Time frame: Up to 48 months post-dose
Long-term immune responses to GEN-003 (Spot-forming units (SFUs), fold rise, responder rate assessed by GrB ELISPOT)
Time frame: Up to 48 months post-dose
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 20 Oct 2017.
- 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
Enrolling by invitationPhase 1
A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) Post-Vaccination
Genital Herpes
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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Herpes Simplex Type 2, run by Genocea Biosciences, Inc. at 13 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 11 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 20 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 13 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.
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?
Long-term effect of GEN-003 on anogenital Herpes simplex virus type 2 (HSV-2) shedding (percent of anogenital swabs positive for HSV-2 DNA by PCR) (time frame: Up to 48 months post-dose). The study lists 2 primary outcomes in all. 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 20 Oct 2017.