We claim:
1. A buffer free, acid stable, rotavirus vaccine comprising rotavirus strain 116E, wherein the said vaccine formulation is capable of eliciting an immune response against rotavirus which is equal to or greater than the immune response generated by any conventional rotavirus vaccine with a buffer.
2. The rotavirus vaccine as claimed in claim 1, wherein the formulation is free of all kinds of buffers to protect the rotavirus antigen from stomach acidity.
3. The rotavirus vaccine as claimed in claim 1, wherein the said vaccine formulation is stable in stomach at pH 2 to pH 4 with no titre loss and is capable to withstand the stomach acidity in humans for a period of at least 20 minutes without any supplement of antacid or buffer.
4. The rotavirus vaccine as claimed in claim 1, wherein the vaccine does not require administration of any antacid or buffer, pre or post administration of the vaccine to the subject.
5. A rotavirus vaccine comprising rotavirus 116E, wherein the dose volume per unit vaccine is upto 1 ml only.
6. The rotavirus vaccine as claimed in claim 5, wherein the dose volume per unit vaccine is 0.8 ml per unit vaccine.
7. The rotavirus vaccine as claimed in claim 5, wherein the dose volume per unit vaccine is 0.5 ml per unit vaccine.
8. The rotavirus vaccine as claimed in claim 1 and 5, wherein the vaccine is stable at -
o 20 C for at least 60 months.
9. The rotavirus vaccine as claimed in claim 1 and 5, wherein the vaccine is stable at 2-
o o o
8 C for least 36 months, at 25 C for 6 months and 37 C for at least 4 weeks.
10. The rotavirus vaccine as claimed in claim 5 and 6, is with or without a buffer.
11. The vaccine formulation as claimed in claim 7, is with or without a buffer.
12. The rotavirus vaccine as claimed in claim 1 and 5, wherein said immune response is generated in terms of four-fold seroconversion post vaccination either similar or greater to that of serconversion achieved with the vaccine formulation either in presence of buffers or by administration of antacids.
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13. The rotavirus vaccine as claimed in claim 1 and 5, wherein the vaccine further comprises combination of sugars, lactalbumin hydrolysate and recombinant human serum albumin.
14. The rotavirus vaccine as claimed in claim 13, wherein the combination of sugars comprises combination of sucrsoe, lactose and trehalose.
15. The rotavirus vaccine as claimed in claim 1 and 5, wherein the formulation is a liquid, oral vaccine formulation.
16. A method of generating immune response in a subject against rotavirus comprising orally administering 0.5 ml of an stabilized rotavirus vaccine formulation without any antacid or buffer, the said formulation comprising a rotavirus strain 116E, combination of sugars selected from sucrose, lactose and trehalose, lactalbumin hydrolysate, recombinant human serum albumin, without presence of any buffer formulation in the said rotavirus vaccine formulation.
17. The method of claim 16, wherein the said rotavirus vaccine formulation does not require administration of any antacid or buffer, pre or post administration of the vaccine to the subject.
18. The method of claim 16, wherein the said rotavirus vaccine formulation is capable to withstand the stomach acidity in humans for a period of at least 20 minutes beween a range of pH 2 to pH 4.
19. The method of claim 16, wherein the said rotavirus vaccine formulation is stable for a period of at least 60 months at -20°C.
20. The method of claim 16, wherein the said rotavirus vaccine formulation is stable for a period of at least 3 years at 2-8°C, period of atleast 6 months at 25°C, and for a period of at least 4 weeks at 37°C.
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21. The method of claim 16, wherein the said vaccine formulation when administered orally to a subject without an antacid or buffer is capable to generate immune response in terms of four-fold seroconversion post vaccination either similar or greater to that of serconversion achieved with the vaccine formulation either in presence of buffers or by administration of antacids.
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