Clinical Trials Directory

Trials / Terminated

TerminatedNCT04642638

Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure

Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Adults at High Risk of SARS-CoV-2 Exposure

Status
Terminated
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
1,307 (actual)
Sponsor
Inovio Pharmaceuticals · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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 coronavirus disease 2019 (COVID-19) in participants at high risk of exposure to severe acute respiratory syndrome coronavirus - 2 (SARS-CoV-2). The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.

Conditions

Interventions

TypeNameDescription
DRUGINO-4800INO-4800 was administered ID on Day 0 and Day 28.
DEVICECELLECTRA® 2000EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28.
DRUGPlaceboSterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28.
DEVICECELLECTRA® 2000EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.

Timeline

Start date
2020-11-30
Primary completion
2022-09-13
Completion
2022-09-13
First posted
2020-11-24
Last updated
2023-12-20
Results posted
2023-12-20

Locations

27 sites across 3 countries: United States, Colombia, Mexico

Regulatory

Source: ClinicalTrials.gov record NCT04642638. Inclusion in this directory is not an endorsement.