Name (Synonyms) | Correlation | |
---|---|---|
drug2253 | Sham intervention Wiki | 1.00 |
drug1029 | HIT-exercise Wiki | 1.00 |
drug977 | GLS-5300 Wiki | 0.71 |
There is one clinical trial.
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.
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 weeksDescription: Administration (injection) site reactions described by frequency
Measure: Administration (injection) site reactions Time: Day0 through up to 60 weeksDescription: 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 weeksDescription: Administration (injection) site pain as described by Visual Analog Scale (VAS)
Measure: Administration (injection) site pain Time: Administration (injection) site painDescription: 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 weeksDescription: Binding antibody titers against MERS-CoV for a 2 and 3 dose vaccination regimens
Measure: Binding antibody titers Time: Day0 through up to 60 weeksDescription: Titers of neutralizing antibodies against MERS-CoV
Measure: Neutralizing antibodies Time: Day0 through up to 60 weeks