Tran Thi Thao, Tran The Trong, Mai Nguyet Thu Hong,
Tan Thi Ngoc Bich, Tran Thanh Son, Ly Phi Phung.
It is well-known that Pasteur Immuno BCG F (fresh) vaccine, used as an adjuvant for immune response, was studied by many researchers.
Recently, some workers have found that this vaccine produces stronger immuno-stimulation and the Pasteur BCG strain gives supperior immuno-potentialization than some others. Not only being used in prevention, this vaccine is also applied in the cancertherapy: leukemia, solid tumors… first experimentally, then clinically. This application of general immuno-stimulation on treatment is called systemic active immunotherapy. The most important view point pulled out from these experiments is that the active immunotherapy can only exterminate a limited quantity of tumor cells, therefore its major indication aims at the “the residual sick cells” alive after a previous treatment (chemotherapy, radiotherapy…)
From these observations and the increasing demands after cancer therapeutics in using liquid BCG vaccine, we applied to produce Pasteur Immuno BCG vaccine.
The results of quality control of batches:
-
Sterility
test: conformed.
-
Safety
test: all guinea pigs raised weight from 88 to 200g/each after 6 weeks of
observation.
-
Skin
test: conformed.
-
Delayed
type hypersensitivity reaction: conformed.
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Viability:
10-106 to 14 - 106 CFU/mg vaccine.
Storage during 6 months at –200C,
the Viable Units were more than 90 %.
at + 40C, it decreased
to 49 % after 3 months, and 31 % after 6 months,
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Validity:
6 months at –200C.
One Immuno BCG vaccine ampoule contains:
§
1ml
of vaccine suspension.
§
75mg
of BCG (fresh weight).