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The histamine-sensitizing (HS) activities of commercial precipitated diphtheria-tetanus-purified pertussis combined vaccines (DTP) submitted to the national quality control tests during the period from 1980 to 1991 were measured in mice on days 4 (EHS) and 12 (LHS) of sensitization. Annual averages of the EHS activity of the vaccines showed continuous decline during the period, while the LHS activity stayed unchanged except for 1990 and 1991. Correlation analysis between these two HS activities revealed that the vaccines could be differentiated into two groups, those showing a significant correlation and those lacking it, depending on their source manufacturers. When the vaccine was incubated at 37 C for four weeks, both the HS activities increased for the first couple of weeks at different rates, reaching their peaks after different periods; three weeks for the EHS activity and two weeks for the LHS activity. Treating the reference pertussis vaccine (for toxicity tests) with anti-pertussis toxin horse serum neutralized completely the EHS activity but the LHS activity resisted the serum. These findings suggest a possible difference between the two HS activities in their mode of action, therefore, in their roles in possible reactogenicity of the vaccine, and a necessity for separate controls of the two activities.

TWO DIFFERENT HISTAMINE-SENSITIZING ACTIVITIES OF PERTUSSIS VACCINE OBSERVED IN MICE ON THE 4TH AND 12TH DAYS OF SENSITIZATION