Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers (NCT03721718) | Clinical Trial Compass
CompletedPhase 1/2
Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers
South Korea60 participantsStarted 2018-08-28
Plain-language summary
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.
Who can participate
Age range
19 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 19-70 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 either remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile during this trials , or have a partner who is medically unable to induce pregnancy.
. Normal screening ECG or screening ECG with no clinically significant findings;
. Screening laboratory must be within normal limits or have only Grade 0-1 findings;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. No history of clinically significant immunosuppressive or autoimmune disease.
. Not currently or within the previous 4 weeks taking immunosuppressive agents (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose less than or equal to 10 mg/day or steroid equivalent).
Exclusion criteria
. Administration of an investigational compound either currently or within 90 days of first dose;
. Previous receipt of an investigational product for the treatment or prevention of MERS-CoV or SARS-CoV except if subject is verified to have received placebo;
. Previous infection with MERS-CoV;
. Administration of any vaccine within 4 weeks of first dose;
. Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose
. Administration of any blood product within 3 months of first dose;
. Pregnancy or breast feeding or plans to become pregnant during the course of the study;
. History of positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor;