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1. (WO2002007764) AMELIORATIONS PORTANT SUR DES VACCINS CONTENANT UN ANTIGENE CONTRE BORDETELLA PERTUSSIS
Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

CLAIMS

1 . A method of preparing a conjugate of (i) an antigen, and (ii) a B. pertussis fimbrial protein, comprising:- separating B. pertussis fimbriae into fimbrial protein subunits; and conjugating the antigen to the fimbrial protein subunits.

2. A method according to Claim 1 , comprising dissociating B. pertussis fimbriae so as to separate fimbriae containing many repeat fimbrial protein subunits into individual subunits.

3. A method according to claim 2 wherein the fimbriae are dissociated using guanidine-hydrochloride.

4. A method according to claim 2 or 3 further comprising denaturing the fimbrial protein subunits.

5. A method according to Claim 4 wherein the fimbriae are denatured using guanidine hydrochloride, with optional addition of a reducing agent.

6. A method according to any preceding claim, wherein conjugating the fimbrial protein subunit to the antigen comprises:- (a) combining a fimbrial protein subunit and an antigen in solution; and

(b) either (i) derivatising the fimbrial protein subunit or (ii) derivatising the antigen; and
(c) maintaining the resultant solution to allow conjugation of the antigen to the dissociated fimbriae.

7. A method according to Claim 6, comprising: dialysing the resultant solution;
lyophilizing the dialysed solution; and
recovering lyophilized conjugate.

8. A method according to any of Claims 1 to 7, comprising
treating the fimbriae so as to dissociate the fimbriae into fimbrial protein subunits,
further treating the fimbriae so as to denature the dissociated fimbrial protein subunits,
conjugating the denatured, dissociated fimbrial protein subunits with antigen, and
allowing the denatured, dissociated fimbrial protein subunits to renature at least partially and to form aggregates of fimbrial protein-antigen conjugates.

9. A method according to Claim 8, wherein denaturing of the dissociated fimbrial protein subunits is carried out under harsh denaturing conditions, such as by using a high concentration of denaturing agent, and the denaturing conditions are then relaxed, such as by reducing the concentration of denaturing agent, so as to allow at least partial renaturing of the fimbrial protein subunits.

1 0. A method according to any preceding claim, comprising conjugating a first antigen to a fimbrial protein subunit to make a first conjugate preparation, conjugating a second antigen to a fimbrial protein subunit to make a second conjugate preparation, and admixing the first and second preparations.

1 1 . A conjugate, comprising:- (a)an antigen, conjugated to
(b)a carrier selected from (i) dissociated B. pertussis fimbriae (ii) denatured B. pertussis fimbriae, and (iii) mixtures of (i) and (ii) .

1 2. A composition comprising conjugates according to Claim 1 2, and comprising at least:- (a)a first antigen; and
(b)a second antigen, different from the first; both conjugated to carriers.

1 3. A composition comprising a microparticle and a conjugate according to Claim 1 1 , wherein the conjugate is inside the microparticle and the microparticle is 1 0 microns or less in diameter.

14. A composition according to Claim 1 3 wherein the microparticle consists of or comprises a polymer selected from (i) lactide-containing polymers (ii) glycolide-containing polymers, and (iii) polymers containing both lactide and glycolide.

1 5. A vaccine comprising a conjugate according to Claim 1 1 or a composition according to any of Claims 12 to 14.

1 6. Use of a carrier selected from (i) dissociated B. pertussis fimbriae (ii) denatured B. pertussis fimbriae, and (iii) mixtures of (i) and (ii) in manufacture of a vaccine.

1 7. A method of vaccination comprising administering an effective amount of a conjugate, wherein the conjugate comprises
(a) an antigen, conjugated to
(b) a carrier selected from (i) dissociated B. pertussis fimbriae (ii) denatured B. pertussis fimbriae, and (iii) mixtures of (i) and (ii).

1 8. A vaccinating composition, comprising dissociated and/or denatured B. pertussis fimbria in a pharmaceutically acceptable carrier.

1 9. A vaccinating composition according to Claim 18, wherein fimbrial protein subunits are adsorbed onto particles of 1 0 microns or less in diameter.

20. An oral vaccinating composition according to Claim 1 8 or 1 9 comprising a suspension of mineral particles.

21 . An oral vaccinating composition according to any of Claims 1 8 to 20 comprising alum particles.

22. An oral vaccinating composition according to any of Claims 1 8 to 21 , further comprising a component to neutralise gut acid.

23. An oral vaccinating composition according to any of Claims 1 8 to 22, comprising a conjugate according to any of Claims 1 1 to 1 2.

24. Dissociated B. pertussis fimbriae.

25. Denatured and dissociated B. pertussis fimbriae.

26. Use of dissociated B. pertussis fimbriae in manufacture of a vaccine against meningococcal disease.

27. Use of dissociated B. pertussis fimbriae in manufacture of a vaccine against Hib disease.