Clinical Research Puerto Rico | San Juan, PR
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Phase I study of the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2 (COVID-19)
Full description
This Phase I, randomized, placebo-controlled, dose-ranging, single-blind study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration of GLS-5310. Vaccine delivered ID will either be performed by Mantoux injection and followed by suction applied to the skin surface using the Gene-Derm device or Mantous injection alone without applied suction. Vaccine delivered IN will be administered using the MAD300 atomizer.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Persons involved in the care of patients with COVID-19 and health care workers considered, in the opinion of the investigator, to be at increased risk of infection from SARS-CoV-2
Persons with symptoms in the past 2 weeks consistent with possible acute SARS-CoV-2 infection to include fever, loss of smell or taste
Persons diagnosis of type 2 diabetes mellitus
Persons with a diagnosis of chronic kidney disease
Persons with a diagnosis of chronic obstructive pulmonary disease (COPD)
Persons with a diagnosis of heart conditions to include heart failure, coronary artery disease, prior heart attack, cardiomyopathy
Obesity (BMI of 30 kg/m2 or greater)
Sickle cell disease
Current or former smoker
Current or planned pregnancy during the study
Currently breastfeeding
Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study, or receipt of a SARS-CoV-2 vaccine that has been approved by the FDA, including vaccines that have received Emergency Use Authorization (EUA)
Administration of an investigational agent within 90 days of the 1st dose
Administration of a vaccine within 2 weeks prior to the 1st dose
Administration of immune globulin within 6 months of enrollment
Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 6 months from enrollment
Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater; or the equivalent dose of other systemic corticosteroids
Treatment within the four weeks prior to enrollment with any drug intended for the prophylaxis or treatment of COVID-19
Any prior treatment with an anti-SARS-CoV-2 monoclonal antibody or immune serum
Prior treatment with an anti-IL-6 inhibitor, anti-IL-1 inhibitor, anti-TNF monoclonal antibody, or anti-JAK inhibitor (see Appendix B exclusionary period for specific drugs)
History of malignancy
History of transplantation (any organ or bone marrow)
Current or planned chemotherapy treatment for hematologic or solid tumor during study period
History of other congenital or acquired immunodeficiency, excluding those with HIV infection who are taking highly active antiretroviral therapy and who have documentation of undetectable serum viral load
History of PCR-confirmed infection with SARS-CoV-2
Not willing to allow storage and future use of samples for SARS-CoV-2 related research and who have a CD4 count > 200 cells/µL on two measures at least 3 months apart
Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness
Any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint
Exclusion criteria (ID + IN only):
History of chronic rhinosinusitis
History of nasal septal defect or deviated nasal septum
History of cleft palate
History of nasal polyps
History of other disorders that, in the opinion of the investigator, may adversely affect administration of intranasal vaccine
Primary purpose
Allocation
Interventional model
Masking
30 participants in 4 patient groups, including a placebo group
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Central trial contact
Medical Monitor; Project Manager
Data sourced from clinicaltrials.gov
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