Recruitment Status:
Pending
Project Status:
Terminated
Project Description:
This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 in participants at high risk of exp . . .
Primary Sponsor:
Inovio Pharmaceuticals, Inc.
Study Type:
Interventional
Date of Registration:
11 September 2021
Date of FIrst Enrollment:
30 November -0001
Region:
United States of America
Method of Allocation:
Randomized
FDA Clinical Trial Reference (CTR) Number:
2021-CT0626
Sources of Monetary or Material Support:
Advaccine Biopharmaceuticals
Inovio Pharmaceuticals, Inc.
Primary Outcomes:
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay [Time Frame: Baseline up to Day 393]
Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovi . . .
Key Inclusion and Exclusion Criteria:
Inclusion Criteria
Working or residing in an environment with high risk of exposure to SARS-CoV-2 for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings.
Phase 2 only: Scree . . .
Countries of Recruitment:
Brazil, Mexico, Philippines, Belgium, Brazil, Denmark, France, Germany, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Serbia, Spain, Switzerland, United Kingdom, United States
Health Condition(s) or Problem(s) Studied: