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 range18 Years – 50 Years

SexALL

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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;
✓. 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

What they're measuring

Mean change from baseline in safety laboratory measures

Timeframe: Day0 through Week 60

Incidence of solicited adverse events after vaccination

Timeframe: Day0 through Week 60

Incidence of unsolicited adverse events after vaccination

Timeframe: Day0 through Week 60

Incidence of serious adverse events

Timeframe: Day0 through Week 60

Trial details

NCT IDNCT02670187

SponsorGeneOne Life Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexALL

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;
✓. 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

What they're measuring

Mean change from baseline in safety laboratory measures

Timeframe: Day0 through Week 60

Incidence of solicited adverse events after vaccination

Timeframe: Day0 through Week 60

Incidence of unsolicited adverse events after vaccination

Timeframe: Day0 through Week 60

Incidence of serious adverse events

Timeframe: Day0 through Week 60