Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2002-02-28
2004-11-16
Housel, James (Department: 1648)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C424S184100, C424S211100, C435S320100, C536S023100, C536S023720
Reexamination Certificate
active
06818628
ABSTRACT:
The present invention relates to a vaccine formula allowing the vaccination of bovines in particular against respiratory pathology. It also relates to a corresponding method of vaccination.
All bovines are carriers of viruses and bacteria which are potentially pathogenic in widely variable degrees.
Viruses can multiply when the specific immunity is weakened and when there are lesions of the respiratory tract. They are then excreted by the animal and may then contaminate other animals.
Among the viruses which are encountered, there may be mentioned in particular the type 3 parainfluenza virus (PI-3), of moderate inherent pathogenicity, the bovine respiratory syncytial virus (RSV) and the bovine herpesvirus (BHV) also called infectious bovine rhinotracheitis (IBR) virus, of high inherent pathogenicities.
Another virus which is particularly important for its immunodepressant role and its harmful effects on reproduction is the mucosal disease virus or bovine pestivirus (BVDV).
These viruses generally manifest themselves by a primary phase of hyperthermia, flu syndrome and respiratory disorders, with digestive disorders (diarrhoeas) in the case of BVD. This phase may be accompanied by a secondary phase with the onset of bronchopneumonia linked to bacterial, in particular Pasteurella, infections which can lead to death. This phenomenon is exacerbated in particular by the immuno-depression resulting from BVD infection or by the infection of macrophages by PI-3. Other symptoms may further appear, such as abortions with BVD and BHV.
It therefore appears necessary to try to develop an effective prevention against the principal viruses involved in bovine respiratory pathology.
Associations of vaccines against certain viruses responsible for bovine respiratory pathology have already been proposed in the past.
The associations developed so far were prepared from inactivated vaccines or live vaccines and, optionally, mixtures of such vaccines. Their development 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 or from the point of view of the formulations themselves, especially in the case where both inactivated vaccines and live vaccines are combined. 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-93 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's 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).
The polynucleotide vaccines may also use both naked DNAs and DNAs formulated, for example, inside cationic lipid liposomes.
G. J. M. COX has already proposed polynucleotide vaccination against type 1 bovine herpes virus in J. of Virology, Volume 67, No. 9, September 1993, 5664-5667. The authors have also described plasmids integrating the gI (gB), gIII (gC) and gIV (gD) genes.
In Vaccine, Volume 13, No. 4, 415-421, 1995, J. E. CROWE presents a general review of the different methods of vaccination against respiratory syncytial virus and against type 3 parainfluenza virus. This review reexamines all the possibilities offered by the current vaccination techniques and simply suggests that the polynucleotide immunization technique could be useful in the immunization strategy against RSV and PI-3. No plasmid construction or result of vaccination of bovines against these viruses is described in this document.
The invention therefore proposes to provide a multivalent vaccine formula which makes it possible to ensure vaccination against a number of pathogenic viruses involved in particular in bovine respiratory pathology and thus to ensure effective vaccination against this pathology.
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 formula which is easy and inexpensive to use.
Yet another objective of the invention is to provide such a vaccine formula and a method for vaccinating bovines which makes it possible to obtain a multivalent protection with a high level of efficiency and of long duration, as well as good safety and an absence of residues.
The subject of the present invention is therefore a vaccine formula in particular against bovine respiratory pathology, comprising at least three polynucleotide vaccine valencies each comprising a plasmid integrating, so as to express it in vivo in the host cells, a gene with one bovine respiratory pathogen valency, these valencies being selected from the group consisting of bovine herpesvirus, bovine respiratory syncytial virus, mucosal disease virus and type 3 parainfluenza virus, the plasmids comprising, for each valency, one or more of the genes selected from the group consisting of gB and gD for the bovine herpesvirus, F and G for the bovine respiratory syncytial virus, E2, C+E1+E2 and E1+E2 for the mucosal disease virus, and HN and F for the type 3 parainfluenze virus.
Valency in the present invention is understood to mean at least one antigen providing protection against the virus for the pathogen considered, it being possible for the valency to contain, as subvalency, one or more modified or natural genes from one or more strains of the pathogen considered.
Pathogenic agent gene is understood to mean not only the complete gene but also the various nucleotide sequences, including fragments which retain the capacity to induce a protective response. The notion of a gene covers the nucleotide sequences equivalent to those described precisely in the examples, that is to say the sequences which are different but which encode the same protein. It also covers the nucleotide sequences of other strains of the pathogen considered, which provide cross-protection or a protection specific for a strain or for a strain group. It also covers the nucleotide sequences which have been modified in order to facilitate the in vivo expression by the host animal but encoding the same protein.
Preferably, the vaccine formula according to the invention comprises the four valences.
As regards the BHV valency, use is preferably made of the two genes encoding gB and gD, in different plasmids or in one and the same plasmid. Optionally, but less preferably, either of these genes can be used.
For the RSV valency, use is preferably made of the two G and F genes integrated into two different plasmids or into one and the same plasmid. Optionally, but less preferably, the F gene can be used alone.
For the BVD valency, use will preferably be made of a plasmid integrating the E2 gene. Optionally, but less preferably, a plasmid coding for E1 and E2 together or for the combination consisting of C, E1 and E2 can be used.
For the PI-3 valency, use is preferably made of the combination of the two HN and F genes in two different plasmids or in one and the same plasmid. It is also possible to use only the HN gene.
A preferred vaccine formula according to the invention comprises and
Audonnet Jean-Christophe
Baudu Philippe
Bouchardon Annabelle
Riviere Michel
Frommer & Lawrence & Haug LLP
Housel James
Kowalski Thomas J.
Lucas Zachariah
Merial
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