HBsAg-BCG combined vaccine for intracutaneous injection and...

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector

Reexamination Certificate

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C424S189100, C424S225100, C424S248100, C530S350000

Reexamination Certificate

active

07579003

ABSTRACT:
The present invention provides a combined vaccine that includes hepatitis B vaccine (HeVac) and Bacille Calmette-Guerin (BCG) for intracutaneous injection and the method of preparation of such vaccine. The combined vaccine changes the now used liquid agent of the HeVac into a cryoprotectant, thus improving the heat stability of the HBsAg. Because of the cryoprotectant in the combined vaccine, the heat stability of the HBsAg is improved, and the efficacy of the vaccine is only slightly decreased after 30 days at 37° C., and the decrease is lower than with the liquid agent of the HeVac. The present invention changes the newborn's inoculation from two injections into one to simultaneously obtain prophylaxis of hepatitis B and tuberculosis.

REFERENCES:
patent: 4710378 (1987-12-01), Ohtomo et al.
patent: WO 97/29773 (1997-08-01), None
patent: WO 97/33614 (1997-09-01), None
patent: WO 01/34801 (2001-05-01), None
Tain X-E et al. “The interation of hepatitis B vaccine and BCG in simultaneous asministration” Henan Medical Research vol. 4, No. 2, 127-132, 1995, Cited in IDS.
Xiao-En, T. et al. (1995) “The interaction of Hepatitis B Vaccine and BCG in Simultaneous Administration” Henan Medical Research 4:127-132 (Chinese version).
Ota, M.O.C. et al. (2002) “Influence ofMycobacterium bovisBacillus Calmette-Guerin on Antibody and Cytokine Responses to Human Neonatal Vaccination” The Journal of Immunology 168:919-925.
International Search Report from PCT priority application No. PCT/CN2004/000534, Aug. 12, 2004.

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