GLS-5700 in Dengue Virus-Naïve Adults

NCT02809443 | Completed Phase 1 Results DMC

• 1 other identifier: Zika-001
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 3

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.

Conditions

Healthy

Keywords

Zika; Vaccine; DNA

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Serious Adverse Events From Day 0 Through Week 60

  Day 0 through Week 60

Secondary Outcomes (2)

• Binding Antibody Response to Zika Envelope

  Week 14 (2 weeks after the 3rd dose)

• T Cell Response

  Maximum response over follow up period up to 60 weeks.

Study Arms (2)

GLS-5700 at 1 mg

EXPERIMENTAL

DNA/dose

Biological: GLS-5700

GLS-5700 at 2 mg

EXPERIMENTAL

DNA/dose

Biological: GLS-5700

Interventions

GLS-5700 BIOLOGICAL

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

GLS-5700 at 1 mg; GLS-5700 at 2 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• GeneOne Life Science, Inc.: lead
• Inovio Pharmaceuticals: collaborator

Study Sites (3)

Miami Research Associate

Miami, Florida, 33143, United States

Location

University of Pennslyvania

Philadelphia, Pennsylvania, 19104, United States

Location

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

Québec, Canada

Location

Related Publications (1)

• 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.

  PMID: 34525286 DERIVED

MeSH Terms

Conditions

Zika Virus Infection

Interventions

GLS-5700 vaccine

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Results Point of Contact

• Title: Senior Clinical Operations Associate
• Organization: GeneOne Life Science

dkane@genels.us

6106576351

Study Officials

• Joel Maslow, MD

  GeneOne Life Science

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)