LIVE ATTENUATED VACCINES FOR PANDEMIC PREPAREDNESS

Medimmune Vaccines, Inc., Mountain View CA

Investigators

Abstract

Most influenza experts agree that we are "due" for an influenza pandemic. One potential method of protecting public health in the threat of a pandemic would be mass immunization. The research program being proposed will evaluate the feasibility of developing, manufacturing, and distributing a live attenuated vaccine which could ultimately be tested in humans for potential use during an influenza pandemic. The objective will be to test the hypothesis that vaccination with a live attenuated vaccine based on a pandemic virus strain is a feasible and practical way of controlling the spread of influenza during a threat of a pandemic. Aviron is developing a live attenuated vaccine for general use in the prevention of influenza, and is interested in applying this technology to pandemic preparedness efforts in developing a vaccine candidate, as well as building related competencies to ensure widespread vaccination is feasible. Specifically, this research program will determine: the feasibility of generating reassortants containing HA and NA genes derived from avian influenza virus and remaining genes from the cold-adapted A/Ann Arbor/6/60 virus using classic reassortment technique; the characterization and safety evaluation of the reassortants in vitro and in animal models; manufacturing such a vaccine including the release protocols to ensure appropriateness for human testing; the potential for usefulness (in providing safety and efficacy) of the vaccine candidate in providing protection in humans; and the methods required for rapid, efficient distribution and administration of the vaccine to large numbers of people.