抄録
1. From the information obtained from experiments performed with partially refined preparations of the endotoxin, the heat-labile toxin and the lymphocytosis-promoting factor (LPF), the methods for quantitative as well as qualitative determinations of the toxic components in pertussis vaccines were scrutinized. The specifications of the toxicity test prescribed in the U. S. Minimum Requirements for Pertussis Vaccine were re-evaluated.
2. The first specification of the test is defined for checking the concentrations of the endotoxin and the heat-labile toxin. From the slope of regression of body weight difference on the 2nd day on log dose of pertussis vaccine and the presence or absence of change in the slope due to mild heating, pertussis vaccines were classified into three types which reflect the concentration of the heat-labile toxin in vaccines. The magnitude of the regression coefficient seems to be correlated with the acceptance level of the first specification of the above test.
3. The majority of pertussis vaccines produced in Japan were found more or less to contain the lymphocytosis-promoting factor, which is supposed to be responsible for“slow weight gain”and“late death”noticed by Pittman. Therefore, the second specification of the above test is to check the concentration of the lymphocytosis-promoting factor. Several methods for detecting the lymphocytosis-promoting factor in a vaccine were proposed, using body weight loss as the response. Neutralization test utilizing an anti-LPF serum was suggested to be the most useful tool for this purpose.
4. A method for quantitative determination of the endotoxin content in a vaccine was suggested. in which a partially purified lypopolysaccharied preparation is used as a standard.
5. Possibility of standard preparations for use in the toxicity test is discussed.
