Crucell and National Institutes of Health start Ebola vaccine trial

By E. Janene Geiss

Philadelphia, Sept. 26 - Crucell NV said Tuesday that the Ebola vaccine it is developing in partnership with the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has started its phase 1 clinical study.

The randomized, double-blind, placebo-controlled study in 48 healthy volunteers will test the single-shot vaccination in a dose-escalation trial, the Leiden, the Netherlands-based biotechnology company said in a news release.

The start of the trial follows the successful completion of the Investigational New Drug application process required by the Food and Drug Administration in the United States. In preclinical studies, a single shot of the PER.C6-based vaccine protected monkeys completely against a lethal Ebola challenge.

The phase 1 study will be carried out by the Vaccine Research Center in Bethesda, Md. The main factors under examination are the vaccine's safety, tolerability and immunogenicity.

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