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| Name | Class |
|---|---|
| Inovio Pharmaceuticals | INDUSTRY |
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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.
GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLS-5700 at 1 mg | Experimental | DNA/dose |
|
| GLS-5700 at 2 mg | Experimental | DNA/dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS-5700 | Biological | GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events From Day 0 Through Week 60 | Day 0 through Week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 14 (2 weeks after the 3rd dose) |
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Inclusion Criteria:
Exclusion Criteria:
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;
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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| Name | Affiliation | Role |
|---|---|---|
| Joel Maslow, MD | GeneOne Life Science | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associate | Miami | Florida | 33143 | United States | ||
| University of Pennslyvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34525286 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GLS-5700 at 1 mg | DNA/dose GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus |
| FG001 | GLS-5700 at 2 mg | DNA/dose GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GLS-5700 at 1 mg | DNA/dose GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus |
| BG001 | GLS-5700 at 2 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events From Day 0 Through Week 60 | Posted | Number | participants | Day 0 through Week 60 |
|
|
Adverse Event data were collected from Week 0 through Week 60.
Adverse events were graded according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials guidelines that were issued by the Food and Drug Administration in September 2007.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLS-5700 at 1 mg | DNA/dose GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at injection site | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Operations Associate | GeneOne Life Science | 6106576351 | dkane@genels.us |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2016 | Aug 8, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2016 | Nov 5, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| ID | Term |
|---|---|
| C000719754 | GLS-5700 vaccine |
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| 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 |
| Maximum response over follow up period up to 60 weeks. |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| CHU de Québec -Université Laval hopital CHUL Centre de Recherche en infectiologie | Québec | Canada |
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Participants who had received all 3 doses of GLS-5700 in a 1-mg or 2-mg dose. | Posted | Count of Participants | Participants | Week 14 (2 weeks after the 3rd dose) |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | Spot Forming Units per million cells | Maximum response over follow up period up to 60 weeks. |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| EG001 | GLS-5700 at 2 mg | DNA/dose GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus | 0 | 20 | 0 | 20 | 20 | 20 |
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| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |