Vaccine formulations and uses thereof
View Patent ↗A liquid or liquid-frozen composition comprising: a modified vaccinia Ankara (MVA) virus or variant or derivative thereof and mannitol, wherein mannitol is the sole stabilization agent of the composition. The mannitol may provide a stabilizing effect at 0 to +10° C. or in a liquid-frozen composition, for example between −10° C. and −30° C. or between −20° C. and −23.5° C. The MVA may be used as a vaccine or for use in gene therapy, virotherapy, immunotherapy, or cancer therapy in a mammal, preferably a human.
1. A method for stabilizing a liquid or liquid-frozen composition comprising a Modified Vaccinia Virus (MVA) or variant thereof, comprising adding mannitol to the liquid or liquid-frozen composition in a sufficient amount to stabilize the composition, wherein mannitol is the sole stabilization agent of the composition, wherein the composition is substantially free of non-viral protein, and wherein the liquid composition is stable after 4 weeks of storage at 8° C.±2° C. or the liquid-frozen composition is stable after 4 weeks of storage at −23° C.±5° C.
2. The method according to claim 1 , wherein the composition comprises live virus.
3. The method according to claim 1 , wherein the MVA is a recombinant vector virus comprising an immunogenic or therapeutic gene sequence.
4. The method according to claim 3 , wherein the immunogenic gene sequence is from a microorganism selected from the group consisting of adenovirus, herpes simplex, varicella zoster, cytomegalovirus, Epstein Barr virus, hepatitis B virus, influenza virus, human papilloma viruses, parainfluenza virus, measles virus, respiratory syncytial virus, poliovirus, Coxsackie virus, rhinovirus, hepatitis A virus, vaccinia, variola major, variola minor, rotavirus, human T lymphotropic virus-1, human immunodeficiency virus (HIV), rabies virus, rubella virus, Yellow fever virus, arbovirus, Afipia spp, Brucella spp, Burkholderia pseudomallei, Chlamydia, Coxiella burnetii, Francisella tularensis, Legionella pneumophila, Listeria monocytogenes, Mycobacterium avium, Mycobacterium leprae, Mycobacterium tuberculosis, Neisseria gonorrhoeae, Rickettsiae, Salmonella typhi, Shigella dysenteriae, Yersinia pestis, Plasmodium spp, Theileria parva, Toxoplasma gondii, Cryptosporidium parvum, Leishmania, Trypanosoma cruzi and Cryptococcus neoformans.
5. The method according to claim 1 , wherein the composition is substantially aqueous.
6. The method according to claim 1 , comprising between 0.01% and 40% (w/v) mannitol.
7. The method according to claim 6 , comprising between 0.1% and 10% (w/v) mannitol.
8. The method according to claim 7 , comprising about 5% (w/v) mannitol.
9. The method according to claim 1 , wherein the stabilized composition is stored at a temperature between 10° C. and 0° C.
10. A liquid or liquid-frozen composition comprising: (a) a modified vaccinia Ankara (MVA) virus or variant thereof; and (b) mannitol, wherein (b) is the sole stabilization agent of the composition, and wherein the composition is substantially free of non-viral protein, and wherein the liquid composition is stable after 4 weeks of storage at 8° C.±2° C. or the liquid-frozen composition is stable after 4 weeks of storage at −23° C.±5° C.
11. The composition according to claim 10 wherein mannitol provides a stabilizing effect at storage temperatures between 10° C. and 0° C.
12. The composition according to claim 10 wherein the virus is live.
13. The composition according to claim 12 wherein the MVA is a recombinant vector virus comprising an immunogenic or therapeutic gene sequence.
14. The composition according to claim 13 wherein the immunogenic gene sequence is from a microorganism selected from the group consisting of adenovirus, herpes simplex, varicella zoster, cytomegalovirus, Epstein Barr virus, hepatitis B virus, influenza virus, human papilloma viruses, parainfluenza virus, measles virus, respiratory syncytial virus, poliovirus, Coxsackie virus, rhinovirus, hepatitis A virus, vaccinia, variola major, variola minor, rotavirus, human T lymphotropic virus-1, human immunodeficiency virus (HIV), rabies virus, rubella virus, Yellow fever virus, arbovirus, Afipia spp, Brucella spp, Burkholderia pseudomallei, Chlamydia, Coxiella burnetii, Francisella tularensis, Legionella pneumophila, Listeria monocytogenes, Mycobacterium avium, Mycobacterium leprae, Mycobacterium tuberculosis, Neisseria gonorrhoeae, Rickettsiae, Salmonella typhi, Shigella dysenteriae, Yersinia pestis, Plasmodium spp, Theileria parva, Toxoplasma gondii, Cryptosporidium parvum, Leishmania, Trypanosoma cruzi and Cryptococcus neoformans.
15. The composition according to claim 10 wherein the composition is substantially aqueous.
16. The composition according to claim 10 comprising between 0.01% and 40% (w/v) mannitol.
17. The composition according to claim 16 comprising between 0.1% and 10% (w/v) mannitol.
18. The composition according to claim 17 comprising about 5% (w/v) mannitol.