[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]
J Infect Dis. 2019 Mar 19. pii: jiz132. doi: 10.1093/infdis/jiz132. [Epub ahead of print]
Intradermal SynCon® Ebola GP DNA Vaccine is Temperature Stable and Safely Demonstrates Cellular and Humoral Immunogenicity Advantages in Healthy Volunteers.
Tebas P1, Kraynyak KA2, Patel A3, Maslow JN4, Morrow MP2, Sylvester AJ2, Knoblock D2, Gillespie E2, Amante D2, Racine T5, McMullan T2, Jeong M4, Roberts CC4, Park YK4, Boyer J2, Broderick KE2, Kobinger GP5, Bagarazzi M2, Weiner DB3, Sardesai NY2, White SM2.
Author information: 1 University of Pennsylvania, Philadelphia, PA, USA. 2 Inovio Pharmaceuticals, Plymouth Meeting, PA, USA. 3 The Wistar Institute of Anatomy & Biology, Philadelphia, PA, USA. 4 GeneOne Life Science, Gangnam-Gu, Seoul, Korea. 5 Université Laval, Quebec City, QC, Canada.
Non-live 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 NHPs, we performed a clinical study to evaluate both intramuscular (IM) and novel intradermal (ID) DNA delivery.
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 IL-12 followed by in vivo electroporation (EP) using either the CELLECTRA® IM or ID delivery devices.
The safety profile of all five 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 intradermal group. Cellular immune responses were generated with every regimen.
Intradermal delivery of INO-4201 was well-tolerated and resulted in 100% seroreactivity after two doses and elicited interferon-γ T cell responses in over 70% of subjects, providing a new approach for EBOV prevention in diverse populations.
© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: email@example.com.
KEYWORDS: Clinical trial; DNA Vaccine; Ebola; electroporation; immunogenicity; safety; temperature-stable
PMID: 30891607 DOI: 10.1093/infdis/jiz132
Keywords: Ebola; Vaccines.