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Cellectra 2000 ElectroporationWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug981 modification of the planned therapeutic management Wiki 1.00
drug317 GLS-5300 Wiki 0.71

Correlated MeSH Terms (7)

Name (Synonyms) Correlation
D002583 Uterine Cervical Neoplasms NIH 1.00
D001943 Breast Neoplasms NIH 1.00
D014594 Uterine Neoplasms NIH 1.00
D010051 Ovarian Neoplasms NIH 1.00
D014625 Vaginal Neoplasms NIH 1.00
D014846 Vulvar Neoplasms NIH 0.71
D009369 Neoplasms, NIH 0.38

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 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)