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.
GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
GLS 5700 at 2 mg DNA/dose
Clinical Research of Puerto Rico
San Juan, Puerto Rico
Fundacion De Investigation
San Juan, Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico
Mean change from baseline in safety laboratory measures
Time frame: Day 0 through Week 14
Incidence of solicited adverse events after vaccination
Time frame: Day 0 through Week 14
Incidence of unsolicited adverse events after vaccination
Time frame: Day 0 through Week 14
Incidence of serious adverse events
Time frame: Day 0 through Week 14
Binding antibody titers to Zika envelope
Time frame: Day 0 through Week 60 following first dose
Neutralizing antibody response against Zika virus
Time frame: Day 0 through Week 60 following first dose
T cell response
Time frame: Day 0 through Week 60 following first dose
Mean change from baseline for safety measures and adverse events
Time frame: Day 0 through Week 60
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