SARS-CoV-2 DNA Vaccine INO-4800 Induces Durable Immune Responses Capable of Being Boosted in a Phase 1 Open-Label Trial.

Content Provider	Europe PMC
Author	Kraynyak, Kimberly A Blackwood, Elliott Agnes, Joseph Tebas, Pablo Giffear, Mary Amante, Dinah Reuschel, Emma L Purwar, Mansi Christensen-Quick, Aaron Liu, Neiman Andrade, Viviane M Diehl, Malissa C Wani, Snehal Lupicka, Martyna Sylvester, Albert Morrow, Matthew P Pezzoli, Patrick McMullan, Trevor Kulkarni, Abhijeet J Zaidi, Faraz I Frase, Drew Liaw, Kevin Smith, Trevor R F Ramos, Stephanie J Ervin, John Adams, Mark Lee, Jessica Dallas, Michael Brown, Ami Shah Shea, Jacqueline E Kim, J Joseph Weiner, David B Broderick, Kate E Humeau, Laurent M Boyer, Jean D Mammen, Mammen P
Copyright Year	2022
Abstract	BackgroundAdditional SARS-CoV-2 vaccines that are safe and effective as primary vaccines and boosters remain urgently needed to combat the COVID-19 pandemic. We describe the safety and durability of the immune responses following two primary doses and a homologous booster dose of an investigational DNA vaccine (INO-4800) targeting the full-length spike antigen.MethodsThree dosage strengths of INO-4800 (0.5 mg, 1.0 mg, and 2.0 mg) were evaluated in 120 age-stratified healthy adults. Intradermal injection of INO-4800 followed by electroporation at 0 and 4 weeks preceded an optional booster 6-10.5 months after the second dose.ResultsINO-4800 appeared well tolerated, with no treatment-related serious adverse events. Most adverse events were mild and did not increase in frequency with age and subsequent dosing. A durable antibody response was observed 6 months following the second dose; a homologous booster dose significantly increased immune responses. Cytokine producing T cells and activated CD8+ T cells with lytic potential were significantly increased in the 2.0 mg dose group.ConclusionINO-4800 was well tolerated in a 2-dose primary series and as a homologous booster in all adults, including the elderly. These results support further development of INO-4800 for use as a primary vaccine and as a booster.
ISSN	00221899
Journal	The Journal of Infectious Diseases
Volume Number	225
PubMed Central reference number	PMC8807286
Issue Number	11
PubMed reference number	35079784
e-ISSN	15376613
DOI	10.1093/infdis/jiac016
Language	English
Publisher	Oxford University Press
Publisher Date	2022-06-01
Publisher Place	US
Access Restriction	Open
Rights License	This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) © The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
Subject Keyword	SARS-CoV-2 Clinical trial DNA Vaccine INO-4800 COVID-19 Safety Immunogenicity Booster
Content Type	Text
Resource Type	Article
Subject	Infectious Diseases Immunology and Allergy