Crucell and NIH VRC Announce Start of Ebola Vaccine Clinical Trial
Crucell N.V. announced that the Ebola vaccine it is developing in partnership with the Vaccine Research Center (VRC) of the National Institute of Allergy and infectious diseases (NIAID), part of the U.S. National Institutes of Health (NIH), has commenced its Phase I 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 start of the trial follows the successful completion of the Investigational New Drug (IND) application process required by the Food and Drug Administration (FDA) in the US. In preclinical studies, a single shot of the PER.C6®-based vaccine protected monkeys completely against a lethal Ebola challenge. The Phase I study will be carried out by the VRC at the NIH Clinical Center in Bethesda, Maryland. The main factors under examination are the vaccine's safety, tolerability and immunogenicity.
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