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Further studies on effect of storage at high temperatures upon allergenic potency of dried BCG vaccine
Insights
Dried glutamate BCG vaccine retains higher allergenic potency than dried sucrose BCG vaccine after high-temperature storage. Glutamate vaccine showed significant potency decrease only after 50°C storage, unlike sucrose vaccine which decreased at 30°C.
Area of Science:
- Immunology
- Vaccine Development
- Microbiology
Background:
- Bacille Calmette-Guérin (BCG) vaccine is crucial for tuberculosis prevention.
- Vaccine stability, particularly allergenic potency, is vital for efficacy.
- Dried BCG vaccines are used in various formulations, impacting storage stability.
Purpose of the Study:
- To evaluate the impact of high-temperature storage on the allergenic potency of dried glutamate BCG vaccine versus dried sucrose BCG vaccine.
- To compare the stability profiles of two different excipients used in dried BCG vaccine formulations.
Main Methods:
- Dried glutamate and dried sucrose BCG vaccines were stored for one month at 5°C, 30°C, 38.5°C, and 50°C.
- Schoolchildren were vaccinated with these stored vaccines.
- Tuberculin reactions (erythema with Old Tuberculin and induration with purified protein derivative) were assessed 4 and 12 months post-vaccination.
Main Results:
- Glutamate BCG vaccine demonstrated consistently higher allergenic potency than sucrose BCG vaccine after storage above 30°C.
- Sucrose BCG vaccine's potency decreased after one month at 30°C.
- Glutamate BCG vaccine showed a significant potency decrease only after storage at 50°C for one month.
- These stability differences persisted up to 12 months post-vaccination.
Conclusions:
- Dried glutamate BCG vaccine offers superior thermostability compared to dried sucrose BCG vaccine.
- Glutamate may be a more suitable excipient for dried BCG vaccine formulations intended for use in warmer climates or with less stringent cold chain requirements.
Abstract:
The authors describe experiments which were carried out to determine the effect on the allergenic potency of dried glutamate BCG vaccine and dried sucrose BCG vaccine of storage at high temperatures.The two vaccines in question were inoculated into school-children after storage for one month at the following temperatures: 5 degrees C, 30 degrees C, 38.5 degrees C and 50 degrees C. The tuberculin reactions of these children were examined 4 and 12 months after the vaccination, both Japanese Old Tuberculin (OT) and Danish purified tuberculin (PPD) being used in the testing.After storage for one month at temperatures exceeding 30 degrees C, the allergenic potency of the dried glutamate vaccine was consistently higher than that of the dried sucrose vaccine. The decrease in potency of the dried sucrose vaccine was evident after storage at 30 degrees C for one month, whereas the dried glutamate vaccine showed a significant decrease in potency only after storage at 50 degrees C for the same period. This tendency was observed in the tuberculin testing up to 12 months after vaccination, and, furthermore, was apparent whether the post-vaccination tuberculin allergy was estimated in terms of erythema with OT or in terms of induration with PPD.
