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 range19 Years – 70 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 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;
✓. 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

What they're measuring

Incidence of adverse events

Timeframe: Day0 through up to 60 weeks

Administration (injection) site reactions

Timeframe: Day0 through up to 60 weeks

Changes in safety laboratory parameters

Timeframe: Day0 through up to 60 weeks

Administration (injection) site pain

Timeframe: Administration (injection) site pain

Trial details

NCT IDNCT03721718

SponsorGeneOne Life Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-30

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range19 Years – 70 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 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;
✓. 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

What they're measuring

Incidence of adverse events

Timeframe: Day0 through up to 60 weeks

Administration (injection) site reactions

Timeframe: Day0 through up to 60 weeks

Changes in safety laboratory parameters

Timeframe: Day0 through up to 60 weeks

Administration (injection) site pain

Timeframe: Administration (injection) site pain