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Immuno BCG Pasteur F vaccine.

M Gheorghiu, L Chambon, C Serié

Developments in Biological Standardization

|April 13, 1977

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The Immuno BCG Pasteur-F vaccine, prepared from young cultures, shows good stability for storage. This BCG vaccine remains stable for months at 4°C and years at -70°C, confirmed by multiple tests.

Area of Science:

Microbiology
Immunology
Vaccine Development

Background:

Bacillus Calmette-Guérin (BCG) vaccines are crucial for tuberculosis prevention.
Maintaining BCG vaccine stability is essential for its efficacy and safe administration.
The Immuno BCG Pasteur-F is a specific formulation requiring stability assessment.

Purpose of the Study:

To evaluate the stability of the Immuno BCG Pasteur-F vaccine under different storage conditions.
To determine the optimal preservation methods for maintaining vaccine viability.

Main Methods:

Preparation of Immuno BCG Pasteur-F from 7-8 day old cultures.
Suspension of the vaccine in Dubos' modified medium.
Storage of the vaccine at 4°C for up to 3 months and at -70°C for extended periods.

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Assessment of vaccine stability through colony-forming unit counts, animal biological controls, and allergy tests in children.

Main Results:

The Immuno BCG Pasteur-F vaccine demonstrated good stability when stored at 4°C for 3 months.
Long-term stability was observed for many years when the vaccine was preserved at -70°C.
Biological controls in animals and allergy tests in children corroborated the vaccine's stability.

Conclusions:

Immuno BCG Pasteur-F vaccine exhibits favorable stability characteristics under recommended storage conditions.
The vaccine can be reliably stored for extended periods, ensuring its availability and potency.
These findings support the use of Immuno BCG Pasteur-F in vaccination programs.