GLS-5700 in Dengue Virus-Naïve Adults (NCT02809443) | Clinical Trial Compass
CompletedPhase 1
GLS-5700 in Dengue Virus-Naïve Adults
United States, Canada40 participantsStarted 2016-07
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
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;
✕
What they're measuring
1
Number of Participants With Serious Adverse Events From Day 0 Through Week 60
. 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;