Intradermal SynCon® Ebola GP DNA vaccine is temperature stable and safely demonstrates cellular and humoral immunogenicity advantages in healthy volunteers
P Tebas, KA Kraynyak, A Patel… - The Journal of …, 2019 - academic.oup.com
P Tebas, KA Kraynyak, A Patel, JN Maslow, MP Morrow, AJ Sylvester, D Knoblock…
The Journal of infectious diseases, 2019•academic.oup.comBackground Nonlive vaccine approaches that are simple to deliver and stable at room
temperature or 2–8° C could be advantageous in controlling future Ebola virus (EBOV)
outbreaks. Using an immunopotent DNA vaccine that generates protection from lethal EBOV
challenge in small animals and nonhuman primates, we performed a clinical study to
evaluate both intramuscular (IM) and novel intradermal (ID) DNA delivery. Methods Two
DNA vaccine candidates (INO-4201 and INO-4202) targeting the EBOV glycoprotein (GP) …
temperature or 2–8° C could be advantageous in controlling future Ebola virus (EBOV)
outbreaks. Using an immunopotent DNA vaccine that generates protection from lethal EBOV
challenge in small animals and nonhuman primates, we performed a clinical study to
evaluate both intramuscular (IM) and novel intradermal (ID) DNA delivery. Methods Two
DNA vaccine candidates (INO-4201 and INO-4202) targeting the EBOV glycoprotein (GP) …
Background
Nonlive vaccine approaches that are simple to deliver and stable at room temperature or 2–8°C could be advantageous in controlling future Ebola virus (EBOV) outbreaks. Using an immunopotent DNA vaccine that generates protection from lethal EBOV challenge in small animals and nonhuman primates, we performed a clinical study to evaluate both intramuscular (IM) and novel intradermal (ID) DNA delivery.
Methods
Two DNA vaccine candidates (INO-4201 and INO-4202) targeting the EBOV glycoprotein (GP) were evaluated for safety, tolerability, and immunogenicity in a phase 1 clinical trial. The candidates were evaluated alone, together, or in combination with plasmid-encoded human cytokine interleukin-12 followed by in vivo electroporation using either the CELLECTRA® IM or ID delivery devices.
Results
The safety profile of all 5 regimens was shown to be benign, with the ID route being better tolerated. Antibodies to EBOV GP were generated by all 5 regimens with the fastest and steepest rise observed in the ID group. Cellular immune responses were generated with every regimen.
Conclusions
ID delivery of INO-4201 was well tolerated and resulted in 100% seroreactivity after 2 doses and elicited interferon-γ T-cell responses in over 70% of subjects, providing a new approach for EBOV prevention in diverse populations.
Clinical Trials Registration. NCT02464670.
Oxford University Press