HealthyPhase 1NCT02809443
GLS-5700 in Dengue Virus-Naïve Adults
A Phase 1 study testing GLS-5700 in people with Healthy, run by GeneOne Life Science, Inc. at 3 sites in 2 countries.
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. ZIKA-001 is the first in man 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
- Conditions the study is for
- Healthy
- What is being tested?
- GLS-5700
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 is medically unable to become pregnant;
- Normal screening ECG or screening ECG with no clinically significant findings;
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- Screening laboratory must be within normal limits or have only Grade 0-1 findings;
- No history of clinically significant immunosuppressive or autoimmune disease.
- No history of dengue virus vaccination or illness; no history of yellow fever vaccination.
- Dengue seronegative at baseline by screening laboratory evaluation
- 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 corticosteroids at a dose less than 20 mg/day).
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 except if participant 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 plans to become pregnant during the course of the study;
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- Positive 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, except for Grade 2 creatinine;
- 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 corticosteroids at a dose less than 20 mg/day);
- 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 participants 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 participant or the evaluation of any study endpoint.
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Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Miami Research Associate
Miami, Florida, 33143
University of Pennslyvania
Philadelphia, Pennsylvania, 19104
Canada1 site
CHU de Québec -Université Laval hopital CHUL Centre de Recherche en infectiologie
Québec
About this study
Official title: Phase I, Open-label, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5700 Administered ID Followed by EP in Dengue Virus-Naïve 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. ZIKA-001 is the first in man clinical trial of this vaccine which encodes for the premembrane-membrane and envelope regions of Zika virus.
Read the detailed description
GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus.
- Conditions
- Healthy
- Being tested
- GLS-5700
- Keywords
- Zika, Vaccine, DNA
- 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 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
| Study group | Role | What they receive |
|---|---|---|
| GLS-5700 at 1 mg | Experimental | DNA/dose Receives: Biological: GLS-5700 |
| GLS-5700 at 2 mg | Experimental | DNA/dose Receives: Biological: GLS-5700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serious Adverse Events From Day 0 Through Week 60
Measured: Day 0 through Week 60
Secondary outcomes (2)
Binding Antibody Response to Zika Envelope
Serum samples were analyzed on enzyme-linked immunosorbent assay (ELISA) to measure binding-antibody responses to recombinant vaccine-matched ZIKV envelope (rZIKV-E) protein and reported as the number of participants who responded.
Measured: Week 14 (2 weeks after the 3rd dose)
T Cell Response
PBMCs were tested in enzyme-linked immunospot (ELISPOT) assay to detect the production of interferon-γ-secreting cells in response to stimulation with ZIKV premembrane and envelope peptides
Measured: Maximum response over follow up period up to 60 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeneOne Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inovio Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Joel Maslow, MD, Study chair, GeneOne Life Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809443
- Sponsor's protocol ID
- Zika-001
- Status last verified
- Nov 2024
- First submitted
- 20 Jun 2016
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tebas P, Roberts CC, Muthumani K, Reuschel EL, Kudchodkar SB, Zaidi FI, White S, Khan AS, Racine T, Choi H, Boyer J, Park YK, Trottier S, Remigio C, Krieger D, Spruill SE, Bagarazzi M, Kobinger GP, Weiner DB, Maslow JN. Safety and Immunogenicity of an Anti-Zika Virus DNA Vaccine. N Engl J Med. 2021 Sep 16;385(12):e35. doi: 10.1056/NEJMoa1708120.
PubMed 34525286
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-label, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5700 Administered ID Followed by EP in Dengue Virus-Naïve Adults
- ClinicalTrials.gov ID
- NCT02809443
- Acronym / sponsor ID
- Zika-001
- Conditions
- Healthy
- Keywords
- Zika, Vaccine, DNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GeneOne Life Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Inovio Pharmaceuticals
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Posted 24 Dec 2024
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. ZIKA-001 is the first in man clinical trial of this vaccine which encodes for the premembrane-membrane and envelope regions of Zika virus.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLS-5700 at 1 mg | Experimental | Biological: GLS-5700DNA/dose |
| GLS-5700 at 2 mg | Experimental | Biological: GLS-5700DNA/dose |
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 is medically unable to become pregnant;
Key exclusion criteria (25 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 except if participant 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 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus | Biological | GLS-5700 at 1 mg, GLS-5700 at 2 mg |
Primary outcome
Number of Participants With Serious Adverse Events From Day 0 Through Week 60
Time frame: Day 0 through Week 60
2 secondary outcomes
Binding Antibody Response to Zika Envelope
Time frame: Week 14 (2 weeks after the 3rd dose)
T Cell Response
Time frame: Maximum response over follow up period up to 60 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34525286Tebas P, Roberts CC, Muthumani K, Reuschel EL, Kudchodkar SB, Zaidi FI, White S, Khan AS, Racine T, Choi H, Boyer J, Park YK, Trottier S, Remigio C, Krieger D, Spruill SE, Bagarazzi M, Kobinger GP, Weiner DB, Maslow JN. Safety and Immunogenicity of an Anti-Zika Virus DNA Vaccine. N Engl J Med. 2021 Sep 16;385(12):e35. doi: 10.1056/NEJMoa1708120.
- 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.
Joel Maslow, MD study chair
GeneOne Life Science
3 sites in 2 countries: 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, run by GeneOne Life Science, Inc. at 3 sites in 2 countries.
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 25 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 24 Dec 2024. 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 United States, Canada. 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?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Serious Adverse Events From Day 0 Through Week 60 (time frame: Day 0 through Week 60). 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 NCT02809443, 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 24 Dec 2024.