This is an open label, phase 1 clinical trial of an intra-dermal booster dose of INO-4800 alone or in combination with INO-9112 followed by electroporation (EP) among healthy adults at least 18 years of age, who previously completed their primary immunization series with mRNA vaccines against SARS-CoV-2 within 6-12 months prior to the booster dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
INO-4800 will be given at 0.8 or 1.6 mg for at least 6 months but no more than 12 months following the completion of a primary vaccination.
INO-9112 will be given in at various doses (dose of 0, 0.05, 0.10, 0.20 or 0.40 mg) in combination with INO-4800.
Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.
Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs)
Time frame: Baseline up to Day 7
Percentage of Participants with Adverse Events (AEs)
Time frame: Baseline up to Day 28
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: Baseline up to week 52
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Baseline up to week 52
Percentage of Participants with Incidence of medically attended AEs (MAAEs)
Time frame: Baseline up to week 52
Percentage of Participants with Change in SARS-CoV-2 pseudovirus neutralizing titers
Time frame: Baseline up to day 28
Number of Participants with a Change in SARS-CoV-2 pseudovirus neutralizing titers
Time frame: Baseline, Day 7, 14, 84, 180, 224, 280 and 365 post-booster
Number of Participants with SARS-CoV-2 pseudovirus neutralizing titers
Time frame: Days 7, 14, 28, 84, 180, 224, 280 and 365 post-booster
Number of Participants with ARS-CoV-2 Spike binding IgG and change in SARS-CoV-2 Spike binding IgG
Time frame: Days 7, 14, 28, 84, 180 and 365 post-booster
Number of Participants with SARS-CoV-2 cellular immune response as measured by IFN-gamma ELISpot
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Time frame: Day 14 post-booster