Candidate Marburg rAd Serotype 5 vaccine for use in preclinical studies and human clinical trials has been produced in compliance with current Good Manufacturing Practices under contract with Crucell (Leiden, The Netherlands. Vaccine material has been released and tested in preclinical safety studies in compliance with Good Laboratory Practices (GLP). The vaccine has undergone evaluation in preclinical effiacy challenge studies. If these data support continued development of this product, an Investigational New Drug application will be submitted to the US Food and Drug Administration (FDA) for Phase I clinical testing of this vaccine in healthy humans.
