Crucell N.V. has signed a Manufacturing Contract with the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). The NIH is the primary biomedical research institute in the US and is part of the Department of Health and Human Services (DHHS). The contract is for the production of clinical grade Ebola, Lassa and Marburg vaccine candidates for use in human clinical trials.
Funded through the NIH by the US federal government, the Manufacturing Contract has an expected duration of two and a half years. No financial details were disclosed. Under the terms of the contract, Crucell will make clinical grade vaccines based on Crucell's adenoviral vaccine technology and produced on Crucell's human cell line, PER.C6.
The Manufacturing Contract follows on from a previous agreement with the NIH. In May 2002, Crucell entered into a Cooperative Research and Development Agreement (CRADA) with the NIH to develop an Ebola vaccine, which was expanded in August 2002 to include Marburg and Lassa vaccines.
Under the terms outlined in the CRADA, NIAID researchers are providing Crucell with modified Ebola, Marburg and Lassa genes to use in developing the vaccines. The gene sequences transferred by the NIAID are nonpathogenic and cannot be used to create viruses capable of replication. Furthermore, Crucell has the option for exclusive worldwide commercialization rights to the Ebola, Lassa and Marburg vaccines resulting from this collaboration. These vaccines will be targeted towards people living in disease endemic areas in Africa, travelers, government officials, and military personnel. The vaccines could also be useful for biodefense against the deliberate release of these agents if they were to be used for biological warfare.
Ebola and Marburg viruses are related viruses that both cause a highly lethal syndrome of fever and bleeding, called hemorrhagic fever. Outbreaks of Ebola fever and Marburg disease have occurred in Africa in recent years, resulting in hundreds of deaths. Lassa virus is in a different family of viruses. It infects approximately 100,000-300,000 people a year, causing Lassa fever and resulting in thousands of deaths. It is endemic in West Africa and is difficult to control due to the economic, social and political situation in that region.