Influenza virus vaccine composition and methods of use

Abstract

The present invention is directed to enhancing the immune response of a human in need of protection against IV infection by administering in vivo, into a tissue of the human, at least one polynucleotide comprising one or more regions of nucleic acid encoding an IV protein or a fragment, a variant, or a derivative thereof. The present invention is further directed to enhancing the immune response of a human in need of protection against IV infection by administering, in vivo, into a tissue of the human, at least one IV protein or a fragment, a variant, or derivative thereof. The IV protein can be, for example, in purified form or can be an inactivated IV, such as those present in inactivated IV vaccines. The polynucleotide is incorporated into the cells of the human in vivo, and an immunologically effective amount of an immunogenic epitope of an IV, or a fragment, variant, or derivative thereof is produced in vivo. The IV protein (in purified form or in the form of an inactivated IV vaccine) is also administered in an immunologically effective amount.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the benefit of the filing date of U.S. Provisional Application No. 60 / 571,854 filed May 18, 2004, which is incorporated herein by reference in its entirety.REFERENCE TO A SEQUENCE LISTING SUBMITTED ON A COMPACT DISC [0002] This application includes a “Sequence Listing,” which is provided as an electronic document on a compact disk (CD-R). This compact disk contains the file “Sequence Listing.txt” (340,000 bytes, created on May 18, 2005), which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION [0003] The present invention relates to influenza virus vaccine compositions and methods of treating or preventing influenza infection and disease in mammals. Influenza is an acute febrile illness caused by infection of the respiratory tract. There are three types of influenza viruses: A, B, and C “IAV,”“IBV” or “IAC,” respectively, or generally “IV”. Type A, which includes several subty...

AI Technical Summary

Benefits of technology

[0029] The present invention further provides plasmids and other polynucleotide constructs for delivery of nucleic acid fragments of the invention to a vertebrate, e.g., a human, which provide expression of IV polypeptides, or fragments, variants, or derivatives thereof. The present invention further provides carriers, excipients, transfection-facilitating agents, immunogenicity-enhancing agents, e.g., adjuvants, or other agent or agents to enhance the transfection, expression or efficacy of the administered gene and its gene product.

Problems solved by technology

The disease can cause significant systemic symptoms, severe illness requiring hospitalization (such as viral pneumonia), and complications such as secondary bacterial pneumonia.

One disadvantage is that such production process is rather vulnerable due to the varying (micro)biological quality of the eggs.

Another disadvantage is that the process completely lacks flexibility if demand suddenly increases, i.e., in case of a serious epidemic or pandemic, because of the logistical problems due to the non-availability of large quantities of suitable eggs.

Changes which are extreme, and drastic (too drastic to be explained by mutation alone) result in antigenic shift of the virus.

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