Phase I, Open Label Dose Ranging Safety Study of GLS-5300 in Healthy Volunteers (NCT02670187) | Clinical Trial Compass
CompletedPhase 1
Phase I, Open Label Dose Ranging Safety Study of GLS-5300 in Healthy Volunteers
United States75 participantsStarted 2016-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 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 18-50 years; military, civilian, male and female.
. Able to provide consent to participate and having signed an Informed Consent Form.
. Able and willing to comply with all study procedures.
. Women of child-bearing potential agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile from enrollment to 3 months following the last injection, or have a partner who is unable to induce pregnancy.
. Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or unable to become pregnant;
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.
What they're measuring
1
Mean change from baseline in safety laboratory measures
Timeframe: Day0 through Week 60
2
Incidence of solicited adverse events after vaccination
Timeframe: Day0 through Week 60
3
Incidence of unsolicited adverse events after vaccination
. Normal screening ECG or screening ECG with no clinically significant findings;
. Screening labs must be within normal limits or have only Grade 0-1 findings;
. No history of clinically significant immunosuppressive or autoimmune disease.
Exclusion criteria
. Administration of an investigational compound either currently or within 30 days of first dose;
. Previous receipt of an investigational product for the treatment or prevention of MERS CoV except if participant is verified to have received placebo;
. Previous infection with MERS CoV as assessed by self report and solicited exposure history;
. Administration of any vaccine within 4 weeks of first dose;
. A BMI greater than or equal to 35;
. 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 have plans to become pregnant during the course of the study;