Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Recombinant virus encoding one or more heterologous proteins...
Reexamination Certificate
1999-01-15
2001-04-24
Salimi, Ali R. (Department: 1648)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Recombinant virus encoding one or more heterologous proteins...
C424S206100, C424S201100, C424S204100, C424S202100, C424S209100, C424S229100, C435S320100, C536S023720
Reexamination Certificate
active
06221362
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
All of the above-mentioned applications, as well as all documents cited herein and documents referenced or cited in documents cited herein, are hereby incorporated herein by reference. Vectors of vaccines or immunological compositions of the aforementioned applications, as well as of documents cited herein or documents referenced or cited in documents cited herein or portions of such vectors (e.g., one or more or all of regulatory sequences such as DNA for promoter, leader for secretion, terminator), may to the extent practicable with respect to the preferred host of this application, also be employed in the practice of this invention; and, DNA for vectors of vaccines or immunological compositions herein can be obtained from available sources and knowledge in the art, e.g., GeneBank, such that from this disclosure, no undue experimentation is required to make or use such vectors.
The present invention relates to a vaccine formula allowing the vaccination of avian species, in particular chickens. It also relates to a corresponding method of vaccination.
2. Description of Related Art Including Information Disclosed Under 37 C.F.R. §1.97 and 37 C.F.R. §1.98
Associations of vaccines against a number of viruses responsible for pathologies in chicken have already been proposed in the past.
The associations developed so far were prepared from inactivated vaccines or live vaccines. Their use poses problems of compatibility between valencies and of stability. It is indeed necessary to ensure both the compatibility between the different vaccine valencies, whether from the point of view of the different antigens used from the point of view of the formulations themselves. The problem of the conservation of such combined vaccines and also of their safety especially in the presence of an adjuvant also exists. These vaccines are in general quite expensive.
Patent applications WO-A-90 11092, WO-A-92 19183, WO-A-94 21797 and WO-A-95 20660 have made use of the recently developed technique of polynucleotide vaccines. It is known that these vaccines use a plasmid capable of expressing, in the host cells, the antigen inserted into the plasmid. All the routes of administration have been proposed (intraperitoneal, intravenous, intramuscular, transcutaneous, intradermal, mucosal and the like). Various vaccination means can also be used, such as DNA deposited at the surface of gold particles and projected so as to penetrate into the animal's skin (Tang et al., Nature, 356, 152-154, 1992) and liquid jet injectors which make it possible to transfect at the same time the skin, the muscle, the fatty tissues and the mammary tissues (Furth et al., Analytical Biochemistry, 205, 365-368, 1992). (See also U.S. Pat. Nos. 5,846,946, 5,620,896, 5,643,578, 5,580,589, 5,589,466, 5,693,622, and 5,703,055; Science, 259:1745-49, 1993; Robinson et al., seminars in IMMUNOLOGY, 9:271-83, 1997; Luke et al., J. Infect. Dis. 175(1):91-97, 1997; Norman et al., Vaccine, 15(8):801-803, 1997; Bourne et al., The Journal of Infectious Disease, 173:800-7, 1996; and, note that generally a plasmid for a vaccine or immunological composition can comprise DNA encoding an antigen operatively linked to regulatory sequences which control expression or expression and secretion of the antigen from a host cell, e.g., a mammalian cell; for instance, from upstream to downstream, DNA for a promoter, DNA for a eukaryotic leader peptide for secretion, DNA for the antigen, and DNA encoding a terminator.)
The polynucleotide vaccines may also use both naked DNAs and DNAs formulated, for example, inside lipids or cationic liposomes.
BRIEF SUMMARY OF THE INVENTION
The invention therefore proposes to provide a multivalent vaccine formula which makes it possible to ensure vaccination against a number of pathogenic avian viruses.
Another objective of the invention is to provide such a vaccine formula combining different valencies while exhibiting all the criteria required for mutual compatibility and stability of the valencies.
Another objective of the invention is to provide such a vaccine formula which makes it possible to combine different valencies in the same vehicle.
Another objective of the invention is to provide such a vaccine which is easy and inexpensive to use.
Yet another objective of the invention is to provide a method for vaccinating Gallinaceans which makes it possible to obtain protection, including multivalent protection, with a high level of efficiency and of long duration, as well as good safety and an absence of residues.
REFERENCES:
patent: 5916879 (1999-06-01), Webster
patent: WO 95/20660 (1995-08-01), None
patent: WO 96/12808 (1996-05-01), None
patent: WO 96/21034 (1996-07-01), None
O'Meara et al. Immunology and Cell Biology, 1993, vol. 71 (pt 5), pp. 473-488, Oct. 1993.*
Webster et al, Vaccine, Dec. 1994, vol. 12 (16), pp. 1495-1498.*
Robinson et al, Vaccine, 1993, vol. 11 (9), pp. 957-960.*
Xiang et al, Virology, 1995, vol. 209, pp. 569-579.*
Xiang et al, Immunity, Feb. 1995, vol. 2, pp. 129-135.*
Sakaguchi et al. (1996) “Protection of chickens from Newcastle disease by vaccination with a linear plasmid DNA expressing the F protein of Newcastle disease virus” Vaccine 14:747-752.
Audonnet Jean-Christophe
Bouchardon Annabelle
Riviere Michel
Frommer William S.
Frommer & Lawrence & Haug LLP
Kowalski Thomas J.
Merial
Salimi Ali R.
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