HealthyPhase 1NCT02887482
GLS-5700 in Dengue Virus Seropositive Adults
A Phase 1 study testing GLS-5700 in people with Healthy and Zika, run by GeneOne Life Science, Inc. at 3 sites in Puerto Rico.
Trial summary
The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700. GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. This is a Phase 1 clinical trial of this vaccine which encodes for the premembrane-membrane and envelope regions of Zika virus. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- GLS-5700
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 3 sitesPuerto Rico
- Study dates
- Aug 2016to Jun 2018
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years;
- Able to provide consent to participate and having signed an Informed Consent Form (ICF);
- Able and willing to comply with all study procedures;
- Women of child-bearing potential agree to use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile from enrollment to 3 months following the last injection, or have a partner who is medically unable to induce pregnancy.
- Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or medically unable to become pregnant;
- Seropositive for dengue virus infection.
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- Normal screening ECG or screening ECG with no clinically significant findings;
- Screening labs must be within normal limits or have only Grade 0-1 findings, except that creatinine may grade 2 at baseline;
- No history of clinically significant immunosuppressive or autoimmune disease.
- No history of dengue virus vaccination; no history of yellow fever vaccination
- Not currently or within the previous 4 weeks taking immunosuppressive agents (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose less than 10 mg/day, or steroid equivalent).
Who cannot join
- Administration of an investigational compound either currently or within 30 days of first dose;
- Previous receipt of an investigational product for the treatment or prevention of Zika virus infection except if subject is verified to have received placebo;
- Administration of any vaccine within 4 weeks of first dose;
- Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose
- Administration of any blood product within 3 months of first dose;
- Pregnancy or breast feeding or have plans to become pregnant during the course of the study;
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- Negative serologic result for dengue virus (any serotype) or history of receipt of either dengue virus or yellow fever virus vaccination at any time in the past;
- Positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor;
- Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
- Baseline evidence of kidney disease as measured by creatinine greater than 1.5 (CKD Stage II or greater);
- Baseline screening lab(s) with Grade 2 or higher abnormality;
- Chronic liver disease or cirrhosis;
- Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
- Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose equal to or greater than 10 mg/day, or steroid equivalent);
- Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept;
- Prior major surgery or any radiation therapy within 4 weeks of group assignment;
- Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
- Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD)
- Metal implants within 20 cm of the planned site(s) of injection;
- Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection.
- Prisoner or subjects who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness;
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or
- Not willing to allow storage and future use of samples for Zika virus related research
- Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.
Trial locations and contacts
3 sites in 1 country.
Puerto Rico3 sites
Clinical Research of Puerto Rico
San Juan, 00874
Fundacion De Investigation
San Juan, 00909
University of Puerto Rico
San Juan, 00936
About this study
Official title: Phase I, Placebo-Controlled, Double-Blind Study To Evaluate The Safety, Tolerability, AND Immunogenicity Of GLS-5700, Administered ID Followed By Electroporation In Dengue Virus-Seropositive Adults
The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700. GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. This is a Phase 1 clinical trial of this vaccine which encodes for the premembrane-membrane and envelope regions of Zika virus.
Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in South America, Central America, and the Caribbean islands commencing in late 2014 or early 2015. Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome in adults and microcephaly and other birth defects among children born to mothers who are infected during pregnancy. At present no vaccines or treatments have been approved for Zika virus infection.
Read the detailed description
GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus.
- Being tested
- GLS-5700, Placebo
- Keywords
- DNA, Vaccine
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLS-5700Biological
GLS 5700 at 2 mg DNA/dose
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Placebo at 0 mg DNA/dose Receives: Biological: Placebo |
| GLS-5700 | Experimental | GLS 5700 at 2 mg DNA/dose. GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus Receives: Biological: GLS-5700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in safety laboratory measures
Measured: Day 0 through Week 14
Incidence of solicited adverse events after vaccination
Measured: Day 0 through Week 14
Incidence of unsolicited adverse events after vaccination
Measured: Day 0 through Week 14
Incidence of serious adverse events
Measured: Day 0 through Week 14
Secondary outcomes (4)
Binding antibody titers to Zika envelope
Measured: Day 0 through Week 60 following first dose
Neutralizing antibody response against Zika virus
Measured: Day 0 through Week 60 following first dose
T cell response
Measured: Day 0 through Week 60 following first dose
Mean change from baseline for safety measures and adverse events
Measured: Day 0 through Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeneOne Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inovio Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887482
- Sponsor's protocol ID
- Zika-002
- Status last verified
- Jan 2022
- First submitted
- 24 Aug 2016
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Placebo-Controlled, Double-Blind Study To Evaluate The Safety, Tolerability, AND Immunogenicity Of GLS-5700, Administered ID Followed By Electroporation In Dengue Virus-Seropositive Adults
- ClinicalTrials.gov ID
- NCT02887482
- Acronym / sponsor ID
- Zika-002
- Keywords
- DNA, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- GeneOne Life Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Inovio Pharmaceuticals
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 2 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.
The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700. GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. This is a Phase 1 clinical trial of this vaccine which encodes for the premembrane-membrane and envelope regions of Zika virus.
Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in South America, Central America, and the Caribbean islands commencing in late 2014 or early 2015. Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome in adults and microcephaly and other birth defects among children born to mothers who are infected during pregnancy. At present no vaccines or treatments have been approved for Zika virus infection.
Detailed description
GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Biological: PlaceboPlacebo at 0 mg DNA/dose |
| GLS-5700 | Experimental | Biological: GLS-5700GLS 5700 at 2 mg DNA/dose. GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-65 years;
- Able to provide consent to participate and having signed an Informed Consent Form (ICF);
- Able and willing to comply with all study procedures;
- Women of child-bearing potential agree to use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile from enrollment to 3 months following the last injection, or have a partner who is medically unable to induce pregnancy.
- Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or medically unable to become pregnant;
Key exclusion criteria (24 listed)
- Administration of an investigational compound either currently or within 30 days of first dose;
- Previous receipt of an investigational product for the treatment or prevention of Zika virus infection except if subject is verified to have received placebo;
- Administration of any vaccine within 4 weeks of first dose;
- Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose
- Administration of any blood product within 3 months of first dose;
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 |
|---|---|---|
| GLS-5700GLS 5700 at 2 mg DNA/dose | Biological | GLS-5700 |
| Placebo | Biological | Placebo |
Primary outcome
Mean change from baseline in safety laboratory measures
Time frame: Day 0 through Week 14
Incidence of solicited adverse events after vaccination
Time frame: Day 0 through Week 14
Incidence of unsolicited adverse events after vaccination
Time frame: Day 0 through Week 14
Incidence of serious adverse events
Time frame: Day 0 through Week 14
4 secondary outcomes
Binding antibody titers to Zika envelope
Time frame: Day 0 through Week 60 following first dose
Neutralizing antibody response against Zika virus
Time frame: Day 0 through Week 60 following first dose
T cell response
Time frame: Day 0 through Week 60 following first dose
Mean change from baseline for safety measures and adverse events
Time frame: Day 0 through Week 60
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 Jan 2022.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLS-5700 in people with Healthy and Zika, run by GeneOne Life Science, Inc. at 3 sites in Puerto Rico.
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 11 inclusion and 24 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 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Puerto Rico. 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 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.
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?
Mean change from baseline in safety laboratory measures (time frame: Day 0 through Week 14). The study lists 4 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 Jan 2022.