Study of GLS-5700 in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT02809443
• Recruitment Status: Completed
• First Posted: June 22, 2016
• Last Update Posted: August 1, 2018
• Sponsor: GeneOne Life Science, Inc.
• Collaborator: Inovio Pharmaceuticals
• Information provided by (Responsible Party): GeneOne Life Science, Inc.

Study Description

Brief 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.

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Biological: GLS-5700	Phase 1

Detailed Description:

GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: July 2016
• Actual Primary Completion Date: November 2017
• Actual Study Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: GLS-5700 at 1 mg; DNA/dose	Biological: GLS-5700; GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
Experimental: GLS-5700 at 2 mg; DNA/dose	Biological: GLS-5700; GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus

Outcome Measures

Primary Outcome Measures :

1. Mean change from baseline in safety laboratory measures [ Time Frame: Day 0 through Week 60 ]
2. Incidence of solicited adverse events after vaccination [ Time Frame: Day 0 through Week 60 ]
3. Incidence of unsolicited adverse events after vaccination [ Time Frame: Day 0 through Week 60 ]
4. Incidence of serious adverse events [ Time Frame: Day 0 through Week 60 ]

Secondary Outcome Measures :

1. Binding antibody titers to Zika envelope [ Time Frame: Day 0 through Week 60 following first dose ]
2. Neutralizing antibody response against Zika virus [ Time Frame: Day 0 through Week 60 following first dose ]
3. T cell response [ Time Frame: Day 0 through Week 60 following first dose ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Age 18-65 years;
2. Able to provide consent to participate and having signed an Informed Consent Form (ICF);
3. Able and willing to comply with all study procedures;
4. 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.
5. 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;
6. Normal screening ECG or screening ECG with no clinically significant findings;
7. Screening laboratory must be within normal limits or have only Grade 0-1 findings;
8. No history of clinically significant immunosuppressive or autoimmune disease.
9. No history of dengue virus vaccination or illness; no history of yellow fever vaccination.
10. Dengue seronegative at baseline by screening laboratory evaluation
11. 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).

Exclusion Criteria:

1. Administration of an investigational compound either currently or within 30 days of first dose;
2. Previous receipt of an investigational product for the treatment or prevention of Zika virus except if participant is verified to have received placebo;
3. Administration of any vaccine within 4 weeks of first dose;
4. Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose
5. Administration of any blood product within 3 months of first dose;
6. Pregnancy or breast feeding or plans to become pregnant during the course of the study;
7. 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;
8. 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;
9. Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
10. Baseline evidence of kidney disease as measured by creatinine greater than 1.5 (CKD Stage II or greater);
11. Baseline screening lab(s) with Grade 2 or higher abnormality, except for Grade 2 creatinine;
12. Chronic liver disease or cirrhosis;
13. Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
14. 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);
15. Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept;
16. Prior major surgery or any radiation therapy within 4 weeks of group assignment;
17. Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
18. Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD)
19. Metal implants within 20 cm of the planned site(s) of injection;
20. Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection.
21. Prisoner or participants who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness;
22. 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
23. Not willing to allow storage and future use of samples for Zika virus related research

24. 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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Contacts and Locations

Locations

United States, Florida

Miami Research Associate

Miami, Florida, United States, 33143

United States, Pennsylvania

University of Pennslyvania

Philadelphia, Pennsylvania, United States

Canada

CHU de Québec -Université Laval hopital CHUL Centre de Recherche en infectiologie

Quebec, Canada

Sponsors and Collaborators

GeneOne Life Science, Inc.

Inovio Pharmaceuticals

Investigators

• Study Chair: Joel Maslow, MD; GeneOne Life Science

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 - Preliminary Report. N Engl J Med. 2017 Oct 4. doi: 10.1056/NEJMoa1708120. [Epub ahead of print]

• Responsible Party: GeneOne Life Science, Inc.
• ClinicalTrials.gov Identifier: NCT02809443
• Other Study ID Numbers: Zika-001
• First Posted: June 22, 2016
• Last Update Posted: August 1, 2018
• Last Verified: July 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by GeneOne Life Science, Inc.:

Zika; Vaccine; DNA