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GLS-5700

Phase 1

Zika | Monoclonal antibody | Infectious Disease |Inovio Pharmaceuticals, Inc.|Trials Updated: Jan 20, 2022

GLS-5700 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Sep 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

GLS-5700 clinical trials

GLS-5700 · 1 trial · 2 indications

Phase 1 1
NCT02887482GLS-5700 in Dengue Virus Seropositive AdultsHealthy
COMPLETED160 Analytics
PHASE1COMPLETED
GLS-5700 in Dengue Virus Seropositive Adults
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboEXPERIMENTALPlacebo at 0 mg DNA/dose
GLS-5700EXPERIMENTALGLS 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

Interventions

NameTypeDescription
GLS-5700BIOLOGICALGLS 5700 at 2 mg DNA/dose
PlaceboBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

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 me...

Countries:Puerto Rico
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Frequently asked questions about GLS-5700

What is GLS-5700?

GLS-5700 is an investigational vaccine candidate developed by Inovio Pharmaceuticals, Inc. for protection against Zika virus infection. It is a synthetic DNA-based product designed to be administered to healthy adults. GLS-5700 has been studied in a Phase 1 clinical trial and is not approved for any indication.

What is GLS-5700 used for?

GLS-5700 is being developed for the prevention of Zika virus infection. It is intended for use in healthy adults, including those who may have prior exposure to related flaviviruses such as dengue. The candidate has been evaluated in a Phase 1 trial in Puerto Rico.

Who is developing GLS-5700?

GLS-5700 is being developed by Inovio Pharmaceuticals, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol INO. Inovio is the sponsor of the clinical program for this Zika vaccine candidate.

What phase is GLS-5700 in?

GLS-5700 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not approved by the FDA or any regulatory authority. As an investigational product, it remains in early-stage clinical testing.

What clinical trials is GLS-5700 in?

GLS-5700 has been studied in a single Phase 1 clinical trial, NCT02887482, titled "GLS-5700 in Dengue Virus Seropositive Adults." The trial enrolled 160 healthy adult participants in Puerto Rico and has been completed. It was randomized, double-blind, and controlled.