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The Phase 2 segment of the trial enrolled approximately 400 participants, 18 years of age or older.
Preliminary results show that INO-4800 was generally safe, well-tolerated, and immunogenic in all studied age groups in a larger population.
Safety endpoints included systemic and local administration site reactions through 8 weeks post-dose one (or 4 weeks post-dose 2).
Immunology endpoints included antigen-specific binding antibody titers, neutralization titers, and antigen-specific interferon-gamma (IFN-γ) cellular immune responses after two doses of the vaccine.
Vaccine administration was generally safe and well-tolerated. The majority of adverse events were mild and moderate in severity and did not appear to increase in frequency with the second dose.
The geometric mean fold rise (GMFR) of binding and neutralizing antibody levels were statistically significantly greater in the 2.0 mg dose group versus the 1.0 mg dose group.
The T cell immune responses measured by the ELISpot assay were also higher in the 2.0 mg dose group compared to the 1.0 mg dose group.
"The expanded data set enabled a clear dose selection to be made with 2.0 mg as the dose for the global Phase 3 efficacy trial," said Dr. Laurent M. Humeau, INO's Chief Scientific Officer.
Price Action: INO shares are down 2.04% at $6.70 on the last check Monday.
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