Drug – bio-affecting and body treating compositions – Radionuclide or intended radionuclide containing; adjuvant... – Coated – impregnated – or colloidal particulate
Patent
1995-07-10
1999-05-11
Feisee, Lila
Drug, bio-affecting and body treating compositions
Radionuclide or intended radionuclide containing; adjuvant...
Coated, impregnated, or colloidal particulate
424 133, 424489, 424499, 424457, 424460, 424461, A61K51/00;9/16;9/50;9/60
Patent
active
059025654
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates to vaccine preparations, and in one particular embodiment it relates to vaccine preparations of the type which are variously described as controlled- or delayed-release vaccines, pulsatile or pulsed-release vaccines and single-shot vaccines. The preparations of the present invention are relevant for use as human and veterinary vaccines, and are provided in the form of a dry powder, which can be subsequently incorporated into a liquid suspension or in a solid pellet or implant for administration. Typically, administration of the vaccine preparation of the present invention in the form of a liquid suspension is by parenteral administration, for example by subcutaneous or intramuscular injection.
BACKGROUND TO THE INVENTION
Delivery of a full course of vaccine in a single dose has held attraction in both human and veterinary medicine and a number of patents and other publications (e.g. U.K. Patent No. 1,567,503) have addressed this possibility. For veterinary applications, the advantages include: doses, time interval between doses).
In human medicine, the above three advantages are also important with compliance being extremely important in developing countries where repeated access to infants is often not possible. In addition, the pain and suffering associated with vaccination, especially of infants, is an additional reason to favour a single-dose vaccine in human medicine.
Early studies of vaccination using inactivated vaccines (generally tetanus or diphtheria toxoids), have demonstrated the importance of two or more discrete doses of vaccine with an interval of at least 4 weeks, and preferably longer, between doses. A third dose is sometimes necessary to induce an adequate immune response, especially in young animals or infants where transfer of maternal antibodies could interfere with the preliminary immune response.
Recent studies in theoretical immunology have supported these findings and introduced the phrase "affinity maturation". Affinity maturation describes the process whereby plasma cells secreting high affinity antibodies to the desired immunogen are preferentially selected whilst plasma cells secreting antibody of lower affinity are lost. The process involves competition between follicular dendritic cells and plasma cells for antigen binding and thus can only occur effectively in the presence of limiting amounts of antigen. The process of affinity maturation may not commence until 2 to 3 weeks after a primary vaccine dose and it is important that the second dose of antigen not be given until the process is effectively complete. This is readily achievable in a multidose vaccination schedule provided the first dose does not contain too much antigen. However, for this process to be achieved in a single dose delayed-release vaccine, it is important that the second and subsequent doses do not release their antigen payload prematurely. To achieve this, the antigen must be contained within a matrix which has a defined time of degradation. This matrix should be biodegradable, although biocompatible matrixes have been proposed as acceptable. A number of options have been reviewed by Cox & Coulter, 1992.
The major effort to develop delayed release vaccines has centred round the studies of Eldridge et al., 1990; 1991, who used the biodegradable copolymer--polylactide coglycolide to produce antigen-containing microspheres and observed a delayed-release of the antigen contents in vivo (see also Australian Patent Specifications Nos. 79929/87 and 33433/89). Similar observations have been reported by Kreuter, 1990 using nanoparticles produced from acrylate polymers. Although the above workers were able to show that the concept of delayed-release vaccines was possible, the process they used in the preparation of the vaccines suffered from a number of deficiencies making it unsuitable for the routine manufacture of a vaccine. The major problems were: conditions, and proteins).
In European patent publication No. 0486959, in the name of Vectorpharma International S
REFERENCES:
patent: 4578270 (1986-03-01), Csizer et al.
patent: 4806350 (1989-02-01), Gerber
patent: 5242686 (1993-09-01), Chu et al.
Eldridge et al, Infection and Immunity, Sep. 1991, pp. 2978-2986 vol. 59, No. 9.
Bodmeier et al, J Pharm. Pharmacol. 1988 vol. 40, pp. 754-757.
Singhi et al, Pharmaceutical Research, vol. 8, No. 7, 1991 pp. 958-961.
Cox John Cooper
Jacobs Irwin Clay
Mason Norbert Simon
Sparks Robert Edward
Bansal Geetha P.
CSL Limited
Feisee Lila
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