Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-01-15
2002-09-17
Priebe, Scott D. (Department: 1632)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C435S320100, C604S070000
Reexamination Certificate
active
06451770
ABSTRACT:
The present invention relates to an improvement made to the vaccination of bovines.
Immunization and vaccination by direct administration of nucleotide sequences encoding an immunogenic protein (called DNA or polynucleotide vaccination) has been described in Patent Application WO-A-90 11092. The protein encoded by the inserted nucleotide sequence is capable of being expressed in the cells and of bringing about the development of an immune response. (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.). This application envisages the use of naked DNA as well as of DNA contained in liposomes. Preferably, the DNA is introduced into the muscle. The DNA could also be introduced into the skin, into certain organs or into the blood, making it possible for the injection to be carried out in different ways such as by the intradermal route, the transcutaneous route, the intravenous route and the like.
The studies which followed the first descriptions of this technique have demonstrated the benefit of using either the intramuscular route for injecting DNA, or the so-called “gene gun” method which consists in propelling metallic microparticles, such as gold microparticles coated with DNA, directly into the superficial cell layer of the skin.
J. B. ULMER et al., Science, Volume 259, 19 March 1993, 1745-1749; G. J. M. COX et al., J. of Virology, Volume 67, No. 9, September 1993, 5664-5667 and Z. Q. XIANG in Virology 199, 132-140 (1994), have described DNA vaccination trials using the intramuscular route.
It has also been widely demonstrated that the intramuscular route gives superior results to the intradermal route but that, in the final analysis, the most promising route is the use of “gene gun” because, with this technique, the administered doses are much less than the doses required by the intramuscular route. Reference may be made to F. FYNAN et al., in P.N.A.S. USA Volume 90, 11478-11482, December 1993, WO-A-95/20660.
Likewise, D. TANG et al., (Nature 356, 152-154, Mar. 12, 1992) have shown the absence of immune response after the administration of human growth hormone by the intradermal route with the aid of a hypodermic needle. The authors have, on the other hand, demonstrated the obtaining of an immune response with the aid of the “gene gun” technique.
Only E. RAZ et al., (P.N.A.S. USA, Vol. 91, 9519-9523, September 1994) have reported that intradermal administration could induce high antibody titres.
For its part, the “gene gun” technique has the disadvantage of being difficult and expensive to use, since it requires the preparation and the use of gold particles coated with DNA and their administration with the aid of a special propellant.
Some authors have therefore developed an alternative technique which envisages the use of an apparatus for liquid jet administration. There may be mentioned P.A. FURTH et al. in Analytical Biochemistry 205, 365-368, 1992, who describe the use of the apparatus called Ped-o-jet, which is an injector used to deliver human vaccines into muscle tissues, for the administration of a DNA vaccine. The authors report that the injector can cause DNA to pass through the skin and reach the muscles, the fatty tissue and the mammary tissue of live animals.
H. L. VAHLSING et al., in Journal of Immunolog Methods 75 (1994) 11-22, describe the use of the apparatus called Med-E-Jet for transcutaneous and intramuscular administration.
There may also be mentioned M. JENKINS et al., in Vaccine 1995, Volume 13, No. 17, 1658-1664, who describe the use of jet vaccination into the muscle.
The bovine respiratory syncytial virus BRSV is present worldwide and can cause severe diseases of the lower respiratory tract in bovines, this disease being similar to that caused by the respiratory syncytial virus HRSV-in children. During one study, it was found that more than 95% of 2-year old calves were infected with the BRSV virus (Van der Poel et al., Archives of Virology 1993, 133, 309-321).
The need for a vaccine against the BRSV virus is felt but has not given rise to the development of effective vaccines. The first attempts to vaccinate children have led to the appearance of facilitation of the disease after natural infection, suggesting that the vaccination could be dangerous (Anderson et al., Journal of Infectious Diseases, 1995, 171: 1 to 7). It is known, however, that antibodies against the two major surface glycoproteins, F (fusion protein) and G (attachment protein) could play a role in protection (Kimman and Westenbrink, Archives of Virology, 1990, 112: to 25). Numerous studies have also been carried out on mouse-, dog- and ferret-type animal models. On the other hand, vaccination trials on bovines with the purified F protein have not given a conclusive result since, as in children vaccinated with HRSV, the calves developed neutralizing antibodies and nonneutralizing antibodies which could interfere with the immune response during a subsequent infection with the virus (L. D. Nelson et al., Am. J. Vet. Res., Vol. 53, No. 8, August 1992, p. 1315-1321).
The objective of the present invention is to provide an improvement in the vaccination of bovines with DNA, which makes it possible to ensure a vaccination which is at least as effective as vaccination by the intramuscular route or by the “gene gun” technique but which is easier and less expensive to use.
Another objective of the invention is to provide such an improvement leading to increased safety, essentially as regards the vaccination residues present in the tissues.
Another objective of the invention, which relates to the vaccination of animals intended for consumption, is also to ensure safety such that the vaccination has no unfavourable effect on the appearance of the meat.
Another objective of the invention is to provide a means for mass vaccination.
A specific objective of the invention is to provide such a vaccine allowing the protection of bovines against the BRSV virus, the IBR virus, the BVD virus or the PI-3 virus.
The Applicants have found that it is possible to meet these objectives by administering the vaccine by the intradermal route with the aid of a liquid injector without a needle, ensuring, at 5 points, distribution of the vaccine essentially in the epidermis, the dermis and the hypodermis. The trials conducted by the Applicants in the field of vaccination of bovines against the bovine respiratory syncytial virus (Bovine Respiratory Syncytial Virus, BRSV) have made it possible to obtain superior immunization results by this route compared to that obtained by the intramuscular route.
The present invention proposes, for the first time, the vaccination of bovines with polynucleotide vaccines (or DNA vaccines or plasmid vaccines) designed for, and administered by, the intradermal route by means of a liquid jet injector without a needle.
The subject of the present invention is therefore a polynucleotide vaccine formula comprising an intradermally effective quantity of a plasmid combining a DNA sequence encoding an immunogen and a promoter allowing the expression of this immunogen in vivo in the cells of the skin, this vaccine formula being suitable for intradermal administration (the cells of the epidermis, dermis and hypodermis are targeted in particular; the administration is intended in particular to present the expressed antigens to the dendritic Langerhans' cells of the skin,
Rijsewijk Franciscus Antonius Maria
Schrijver Remco Siebren
Van Oirschot Johannes Theodorus
Beckerley Anne Marie S.
Frommer William S.
Frommer & Lawrence & Haug LLP
Kowalski Thomas J.
Merial
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