San Diego, USA-based Vical, a specialist biophamaceuticals developer, says that a Phase I trial of its leading Ebola vaccine candidate shows that the therapeutic is safe and well-tolerated. Moreover, the vaccine, which was administered using the firm's proprietary DNA delivery technology, elicited both antibody and T-cell disease-specific responses in all the healthy volunteers who received three doses.
The study, which was a randomized, placebo-controlled, dose-escalation assessment, was sponsored by the National Institute of Allergy and Infectious Diseases, and was conducted at the National Institutes of Health clinical center. The findings, which were presented at the American Society for Microbiology's 2006 Biodefense Research meeting in Washington DC, earlier this month, showed that subjects receiving the product produced antibody responses specific to at least one of the viral antigens incorporated into the vaccine.
In addition, the firm says that the 2002 Food and Drug Administration requirement that a product demonstrates safety in humans and biological activity in two appropriate animal models, creates a favorable regulatory pathway for certain DNA-based products, like its Ebola vaccine.
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