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GLS-5300Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug182 Cellectra 2000 Electroporation Wiki 0.71
drug981 modification of the planned therapeutic management Wiki 0.71

Correlated MeSH Terms (11)

Name (Synonyms) Correlation
D002583 Uterine Cervical Neoplasms NIH 0.71
D001943 Breast Neoplasms NIH 0.71
D014594 Uterine Neoplasms NIH 0.71
D010051 Ovarian Neoplasms NIH 0.71
D014625 Vaginal Neoplasms NIH 0.71
D014846 Vulvar Neoplasms NIH 0.50
D009369 Neoplasms, NIH 0.27
D003141 Communicable Diseases NIH 0.08
D007239 Infection NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials

1 Phase I, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5300, Administered IM Followed by Electroporation in Healthy Volunteers

The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe pulmonary infection in 2012. Infection with MERS CoV has been diagnosed in more than 1600 individuals with a mortality rate between 35% and 40%. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This study will evaluate the safety of GLS-5300 at one of three dose levels following a three-injection vaccination regimen followed by electroporation. The study will also assess immune responses over a 1 year period with respect to the generation of antibody and cellular responses.

NCT02670187 Healthy Biological: GLS-5300

Primary Outcomes

Measure: Mean change from baseline in safety laboratory measures

Time: Day0 through Week 60

Measure: Incidence of solicited adverse events after vaccination

Time: Day0 through Week 60

Measure: Incidence of unsolicited adverse events after vaccination

Time: Day0 through Week 60

Measure: Incidence of serious adverse events

Time: Day0 through Week 60

Secondary Outcomes

Measure: Binding antibody response to S protein

Time: Day0 through Week 60 following the first dose

Measure: Neutralizing antibody response to S protein

Time: Day0 through Week 60 following the first dose

Measure: T cell response

Time: Day 0 through Week 60 following the first dose

2 Phase I/IIa, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of GLS-5300, Administered ID Followed by CELLECTRA® 2000 (Electroporation, EP)

The Middle East Respiratory Syndrome Coronavirus (MERS CoV), is a cause of severe and highly fatal lower respiratory tract infection, first identified in 2012. As of August 2018, there have been 2229 cases reported with a case fatality rate >35%. In 2015 an individual returning to South Korea served as the index case for an outbreak of 186 individuals, of who, >20% died. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This Phase I/IIa study will evaluate the safety, tolerability and immunogenicity of GLS-5300 administered intradermally (ID) followed by electroporation at 0.3 and 0.6 mg/dose assessing 2 and 3-dose regimens.

NCT03721718 Healthy Biological: GLS-5300 Device: Cellectra 2000 Electroporation

Primary Outcomes

Description: Incidence of Adverse events by System organ class (SOC); preferred term (PT); severity and relationship to study treatment and schedule

Measure: Incidence of adverse events

Time: Day0 through up to 60 weeks

Description: Administration (injection) site reactions described by frequency

Measure: Administration (injection) site reactions

Time: Day0 through up to 60 weeks

Description: Number of participants with changes based on frequency in safety lab parameters in Complete Blood Count and Liver panel tests" or similar.

Measure: Changes in safety laboratory parameters

Time: Day0 through up to 60 weeks

Description: Administration (injection) site pain as described by Visual Analog Scale (VAS)

Measure: Administration (injection) site pain

Time: Administration (injection) site pain

Secondary Outcomes

Description: Antigen specific cellular immune responses to MERS-CoV as determined by Interferon-gamma (IFN-γ) ELISpot

Measure: Cellular Immune Responses

Time: Day0 through up to 60 weeks

Description: Binding antibody titers against MERS-CoV for a 2 and 3 dose vaccination regimens

Measure: Binding antibody titers

Time: Day0 through up to 60 weeks

Description: Titers of neutralizing antibodies against MERS-CoV

Measure: Neutralizing antibodies

Time: Day0 through up to 60 weeks

No related HPO nodes (Using clinical trials)