Preliminary clinical trial results from an ongoing Phase 2/3 trial of the two-dose INO-4800 vaccine by Inovio Pharmaceuticals is safe for use in adults of varying ages. INO-4800 is a plasmid DNA vaccine delivered by electroporation and contains the S1 and S2 subunits of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. The randomized, blinded, placebo-controlled, Phase 2 clinical trial involved 401 patients. 201 participants were randomly assigned either one or two injections of the INO-4800 vaccine at a dose of 1.0 mg or one or two placebo injections.
The first dose would be delivered on the first day of the trial. The second dose was injected on day 28. Injections were given over the deltoid or anterolateral quadricep muscles, followed by electroporation. The second vaccine was injected in a different arm or leg from the first dose. 200 participants were randomly assigned two vaccine doses at 2.0 mg or a placebo in two different limbs.
There were 1,679 adverse events reported in 300 participants after week 8, with 1,446 treatment-related adverse events in 281 participants. The most common adverse events observed in 5% of participants included injection site reactions, fatigue, headache, muscle pain, and nausea. Most adverse events were of Grade 1 and Grade 2 severity. After week 6, both the 1.0 mg and 2.0 mg dose groups showed humoral immune responses. Although, there was a greater humoral immune response associated with the higher dose.
When testing the participants’ serum, the researchers found both dose groups produced neutralizing antibody responses specific to SARS-CoV-2. Again, the 2.0 mg dose group had statistically significantly higher antibody responses than the 1.0 mg dose group. Antibody responses differed amongst age groups. The researchers also observed an increase in T cell immune responses after week 6. The magnitude of IFN trended higher amongst the 1.0 mg vaccine group compared to the 1-injection placebo group. Participants given the 2.0 mg vaccine dose had higher T cell responses than the 2-injection placebo groups.
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