NCT02887482

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2016

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

August 24, 2016

Last Update Submit

January 5, 2022

Conditions

HealthyZika

Keywords

DNAVaccine

Outcome Measures

Primary Outcomes (4)

  • Mean change from baseline in safety laboratory measures

    Day 0 through Week 14

  • Incidence of solicited adverse events after vaccination

    Day 0 through Week 14

  • Incidence of unsolicited adverse events after vaccination

    Day 0 through Week 14

  • Incidence of serious adverse events

    Day 0 through Week 14

Secondary Outcomes (4)

  • Binding antibody titers to Zika envelope

    Day 0 through Week 60 following first dose

  • Neutralizing antibody response against Zika virus

    Day 0 through Week 60 following first dose

  • T cell response

    Day 0 through Week 60 following first dose

  • Mean change from baseline for safety measures and adverse events

    Day 0 through Week 60

Study Arms (2)

Placebo

EXPERIMENTAL

Placebo at 0 mg DNA/dose

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

Biological: GLS-5700

Interventions

GLS-5700BIOLOGICAL

GLS 5700 at 2 mg DNA/dose

GLS-5700
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 medically unable to become pregnant;
  • Seropositive for dengue virus infection.
  • 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).

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 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;
  • 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;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical Research of Puerto Rico

San Juan, 00874, Puerto Rico

Location

Fundacion De Investigation

San Juan, 00909, Puerto Rico

Location

University of Puerto Rico

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Zika Virus Infection

Interventions

GLS-5700 vaccine

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus Infections

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 2, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2017

Study Completion

June 1, 2018

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

PR(3)