Evaluation of the influence of sex and of NIH and BALB/cAn mouse strains in the mouse weight gain test of DTP vaccine
DOI:
https://doi.org/10.22239/2317-269X.01438Keywords:
Mouse Weight Gain Tes, Diphtheria,, etanus and Whole Cell Pertussis Vaccine (Adsorbed);, ertussis Toxin;, NIH Mice, BALB/cAn MiceAbstract
Introduction: The mouse weight gain test (MWGT) for determination of toxicity of whole-cell pertussis vaccine (WCPV) is essential to approve the use of diphtheria, tetanus and whole cell pertussis (DTwP) vaccine (adsorbed) in childhood vaccination programs. Objective: To evaluate the influence of sex and of the mouse strains (NIH and BALB/cAn) on MWGT of the reference WCPV, pertussis toxin (PT) and 36 samples of DTwP vaccines. Method: Ten animals of each sex and strain were weighed, and then inoculated intraperitoneally with 0.5 mL/mouse of the reference WCPV, of PT (0.25-2.0 μg/animal), or DTwP vaccines. Control groups for WCPV and PT were inoculated with PBS and for DTwP vaccines 0.9% sodium chloride was used with 100 ppm of thimerosal. The test is satisfactory if there are no deaths, if the average weight gain (AWG) of the inoculated animals on the 3rd day is higher than the initial one and if on the 7th day the AWG is equal to or greater than 60% of the control. The MWGT results were evaluated by the current and by the proposed criteria on the 7th day, in which the lower limit of the 95% confidence interval of the AWG was equal to or greater than 60% of the control. Results: The reference WCPV was satisfactory in NIH and BALB/cAn females and unsatisfactory in males of both strains considering both criteria. The MWGT in both sexes and strains revealed low sensitivity in detecting the effect of isolated PT (0.25-2.0μg/mouse). DTwP vaccines were satisfactory in NIH mice of both sexes and in BALB/cAn females, but the result was unsatisfactory for 14.0% of DTwP vaccines in BALB/cAn males by both criteria. Conclusions: The MWGT of DTwP vaccines in female mice of both strains should be considered as it has been shown that NIH and BALB/cAn females are suitable for the MWGT. The adoption of the criterion proposed in the 7th day should be stimulated as it increases the sensitivity and precision of the MWGT.
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