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.
GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
Miami Research Associate
Miami, Florida, United States
University of Pennslyvania
Philadelphia, Pennsylvania, United States
CHU de Québec -Université Laval hopital CHUL Centre de Recherche en infectiologie
Québec, Canada
Number of Participants With Serious Adverse Events From Day 0 Through Week 60
Time frame: Day 0 through Week 60
Binding Antibody Response to Zika Envelope
Serum samples were analyzed on enzyme-linked immunosorbent assay (ELISA) to measure binding-antibody responses to recombinant vaccine-matched ZIKV envelope (rZIKV-E) protein and reported as the number of participants who responded.
Time frame: Week 14 (2 weeks after the 3rd dose)
T Cell Response
PBMCs were tested in enzyme-linked immunospot (ELISPOT) assay to detect the production of interferon-γ-secreting cells in response to stimulation with ZIKV premembrane and envelope peptides
Time frame: Maximum response over follow up period up to 60 weeks.
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