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TRIAL ON EXPERIMENTAL BATCHES OF FREEZE-DRIED BCG
VACCINE PRODUCED AT GUINDY LABORATORY |
Kul Bhushan: Bull Dev Prev TB 1962, 9, 16-19. |
Government of India set up a plant for producing
Freeze-Dried vaccine at BCG Vaccine Laboratory, Madras in 1959.
Before releasing the freeze-dried vaccine to the mass campaign it
was necessary that it is subjected to various tests. This paper
deals with two such trials. The first study planned in this connection
was for the assessment of allergising properties of two lots
each of four batches of freeze-dried vaccine. The second study
was to investigate the stability of two lots of a batch of
freeze-dried vaccine in relation to storage at different temperatures
for varying periods.
The results indicate that though the liquid vaccine
has on the whole produced slightly higher allergy than the freeze-dried
vaccine, the level of allergy achieved with the freeze-dried
vaccine is quite adequate. Levels of post-vaccination allergy
in the lots containing glutamate and tween 80, show that increase
in storage temperature has resulted in higher loss of potency of
vaccine. No definite trend is indicated regarding the lots containing
glutamate alone.
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KEY WORDS: FREEZE-DRIED BCG, CLINICAL TRIAL,
POTENCY, STABILITY. |