NCT02887482

GLS-5700 in Dengue Virus Seropositive Adults

Phase I, Placebo-Controlled, Double-Blind Study To Evaluate The Safety, Tolerability, AND Immunogenicity Of GLS-5700, Administered ID Followed By Electroporation In Dengue Virus-Seropositive Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: GeneOne Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Healthy
• Zika

Interventions

Type	Name	Description
BIOLOGICAL	GLS-5700	GLS 5700 at 2 mg DNA/dose
BIOLOGICAL	Placebo

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-10-01
• Completion: 2018-06-01
• First posted: 2016-09-02
• Last updated: 2022-01-20

Locations

3 sites across 1 country: Puerto Rico