Vical's Ebola DNA vaccine shown to be well tolerated, produces immune responses in phase 1 trial

By Lisa Kerner

Erie, Pa., Feb. 21 - Vical Inc. said an Ebola vaccine candidate administered using Vical's proprietary DNA delivery technology was safe and well tolerated and produced both antibody and T-cell Ebola-specific responses in all healthy volunteers who received the full three doses of vaccine in a phase 1 trial.

Ebola hemorrhagic fever is a serious, often-fatal disease that typically impairs the body's ability to regulate itself. Symptoms of the disease include bleeding.

The National Institute of Allergy and Infectious Diseases and the National Institutes of Health (NIH) conducted the randomized, placebo-controlled, dose-escalation study. The study took place at the NIH Clinical Center, according to a company news release.

Subjects received three doses of vaccine or a placebo at one-month intervals, the company said. Three cohorts tested progressively higher doses of the vaccine at 2 mg, 4 mg or 8 mg.

Glycoprotein-specific antibody and T-cell responses were detected in all recipients who received the full three doses at all dose levels.

According to the release, this is the first human trial for any Ebola vaccine.

The vaccine used in the phase 1 trial included three plasmids (closed loops of DNA), one each encoding the surface glycoprotein from the Zaire and Sudan/Gulu strains of Ebola, and the internal nucleoprotein from the Zaire strain.

Vical said it has secured a nonexclusive license from the NIH to proprietary gene sequences used in the vaccine.

"The high rates of immune responses at all dose levels in this initial human Ebola vaccine study support continued development of this vaccine and further evaluation of our technology for potential additional biodefense and emerging disease applications, particularly where antibody responses may be protective," Vical chief scientific officer David C. Kaslow said in the release.

"Our processes allow rapid development and manufacturing of vaccines without handling potentially dangerous pathogens."

The Ebola DNA vaccine under development by the NIH may be eligible for the U.S. government's Project BioShield program, which includes up to $260 million for Ebola vaccines or treatments.

Data from the trial were presented at the American Society for Microbiology 2006 Biodefense Research Meeting in Washington, D.C.

San Diego-based Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.