Effects of elevated temperatures on the opacity and toxicity of pertussis vaccines manufactured with different inactivating agents.

Plain pertussis vaccine manufactured with different inactivating agents was evaluated for its stability at 4-8, 25 and 35 degrees C with regard to the opacity and the toxicity [mouse weight gain test (MWGT) and histamine sensitizing (HS) activity]. Two pools each of heat inactivated pertussis vaccine (HIPV), formaldehyde inactivated pertussis vaccine (FIPV), glutaraldehyde inactivated pertussis vaccine (GIPV), thimerosal inactivated pertussis vaccine (TIPV) and acetone (I) treated pertussis vaccine [A(I)TPV] were taken for the study. The test for determination of opacity and MWGT were performed at monthly intervals for three months and the test for HS activity was performed after three months exposure of the samples at various temperatures. There was almost no loss in the opacity of GIPV and TIPV at all the selected storage temperatures and of HIPV and FIPV at 4-8 degrees C, while A(I)TPV lost about 16% opacity in three months at 4-8 degrees C. At 25 degrees C after three months, the percentage loss in opacity of HIPV averaged about 12, of FIPV 17 and of A(I)TPV 33. At 35 degrees C after three months, the average percentage loss in opacity of HIPV was 16, of FIPV was 25 and of A(I)TPV was 33. Regarding the effect of elevated temperatures on the toxicity of the vaccine, it was observed that the samples held at 35 degrees C for three months were the least toxic followed by those held at 25 and 4-8 degrees C as detected by MWGT and the test for HS activity.