This is a randomized, placebo-controlled, double-blinded phase I study, designed to evaluate the safety including reactogenicity and immunogenicity of this investigational DNA vaccine delivered intramuscularly by in vivo EP in human adults. The vaccine doses will be given to healthy adults aged 18 to 60 years, who have been previously vaccinated against COVID-19 with 3 doses of either Comirnaty® or Spikevax®, or both in any combination ≥3 months ago.
One dose of the investigational vaccine or placebo will be given as a fourth booster dose. The vaccine will be administered intramuscularly at 3 dose levels or given as placebo (containing a 0.9 % NaCl solution), in combination with in vivo EP. The EP method used in the study is a class IIa "EPS Gun" from IGEA optimized for Electro Gene Transfer (EGT) vaccination and CE marked for the intended use in this clinical trial. Primary objective: • The primary objective of this study is to assess the safety and reactogenicity of the investigational vaccine OC-007 DNA delivered by in vivo EP, as a booster dose given at ≥ 3 months post-initial mRNA vaccination. The secondary objectives: • To investigate the humoral immune response to the investigational vaccine administered as one dose, by measuring changes in spike and of nucleocapsid antibody levels. Exploratory objective: * To investigate in more detail the humoral response and analyze the cellular immune response to the investigational vaccine * To evaluate the number of SARS-CoV-2 infections documented by positive PCR test during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
16
Plasmid DNA vaccine
0.9% NaCl solution
Phase I Study Unit, Karolinska University Hospital
Stockholm, Region Stockholm, Sweden
Local reactions after the vaccine/placebo dose
Local reactions (pain at the injection site, redness, and swelling) for up to 7 days after the vaccine/placebo dose
Time frame: Up to 7 days after the vaccine/placebo dose
Visual analogue scale pain rating scale score
Visual analogue scale (VAS) score to rate the level of pain experienced immediately (0 minutes), and after 5, 15, 30 and 60 minutes post-EP. Scale is continous and the farther right on the scale line the more pain.
Time frame: At 0, 5, 15, 30 and 60 minutes post-EP.
Systemic events for 7 days after each vaccine/placebo dose.
Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) for 7 days after each vaccine/placebo dose.
Time frame: For 7 days after each vaccine/placebo dose.
Unsolicited AEs
Unsolicited AEs from the study dose to 28 days after vaccination.
Time frame: From the study dose to 28 days after vaccination.
Serious Adverse Events (SAEs)/SUSARs
Serious Adverse Events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) from the study dose until the study end at 3 months after vaccination.
Time frame: From the study dose until the study end at 3 months after vaccination.
Change from baseline in antibody levels to the SARS-CoV-2 spike and nucleocapsid protein.
Change from baseline sample (a two-fold increase in endpoint titer or a 50% increase in optical density at a 1:62, 1:125, 1:250, 1:500, or 1:1000 serum dilution) in antibody levels to the SARS-CoV-2 spike and nucleocapsid protein by inhouse and/or commercial assays during the study period.
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Time frame: Day 7, Day 14, 1 Month and 3 Months.