Intradermal SynCon® Ebola GP DNA Vaccine Is Temperature Stable and Safely Demonstrates Cellular and Humoral Immunogenicity Advantages in Healthy Volunteers.

Autor:	Tebas P; University of Pennsylvania, Philadelphia., Kraynyak KA; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., Patel A; The Wistar Institute of Anatomy and Biology, Philadelphia, Pennsylvania., Maslow JN; GeneOne Life Science, Gangnam-Gu, Seoul, Korea., Morrow MP; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., Sylvester AJ; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., Knoblock D; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., Gillespie E; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., Amante D; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., Racine T; Université Laval, Quebec City, Quebec, Canada., McMullan T; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., Jeong M; GeneOne Life Science, Gangnam-Gu, Seoul, Korea., Roberts CC; GeneOne Life Science, Gangnam-Gu, Seoul, Korea., Park YK; GeneOne Life Science, Gangnam-Gu, Seoul, Korea., Boyer J; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., Broderick KE; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., Kobinger GP; Université Laval, Quebec City, Quebec, Canada., Bagarazzi M; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., Weiner DB; The Wistar Institute of Anatomy and Biology, Philadelphia, Pennsylvania., Sardesai NY; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania., White SM; Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania.
Jazyk:	angličtina
Zdroj:	The Journal of infectious diseases [J Infect Dis] 2019 Jul 02; Vol. 220 (3), pp. 400-410.
DOI:	10.1093/infdis/jiz132
Abstrakt:	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. (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu