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Testing of adsorbed diphtheria-pertussis-tetanus (DPT) vaccine for freedom from abnormal toxicity
S K Bhandari1, R K Gupta, S B Sharma
1Biological Standardization and Quality Control Division, Central Research Institute, Kasauli, India.
Abstract:
A total of 112 samples of adsorbed DPT vaccine were tested in mice for freedom from abnormal toxicity by three procedures: (a) single human dose by intraperitoneal route; (2) single human dose by subcutaneous route; and (3) half the single human dose by intraperitoneal route. The percentage of samples passing by the three methods was 25, 90 and 54.5, respectively. Method 3, which is being recommended now by the World Health Organization, is supported by the results of this study to be neither very stringent nor very lenient to pass the adsorbed DPT vaccine for freedom from abnormal toxicity.
Insights
Testing adsorbed Diphtheria, Pertussis, and Tetanus (DPT) vaccine safety in mice revealed Method 3, a World Health Organization recommendation, offers a balanced approach for toxicity assessment.
Area of Science:
- Pharmacology
- Immunology
- Toxicology
Background:
- The Diphtheria, Pertussis, and Tetanus (DPT) vaccine is critical for pediatric immunization.
- Ensuring the safety of adsorbed DPT vaccines through rigorous toxicity testing is paramount.
Purpose of the Study:
- To evaluate the efficacy of three distinct testing procedures for assessing the abnormal toxicity of adsorbed DPT vaccine samples in mice.
- To determine if the World Health Organization-recommended Method 3 provides an appropriate balance in toxicity assessment.
Main Methods:
- 112 adsorbed DPT vaccine samples were tested in mice using three different administration routes and dosages.
- Method (a): Single human dose via intraperitoneal route.
- Method (b): Single human dose via subcutaneous route.
- Method (c): Half human dose via intraperitoneal route.
Main Results:
- The pass rates for the three methods were 25% (Method a), 90% (Method b), and 54.5% (Method c).
- Method c, recommended by the WHO, demonstrated a moderate pass rate.
- The results suggest Method c is neither excessively stringent nor lenient.
Conclusions:
- Method 3, involving a half human dose via intraperitoneal route, is a suitable method for assessing the abnormal toxicity of adsorbed DPT vaccines.
- The study supports the continued use and recommendation of Method 3 by the World Health Organization for DPT vaccine safety evaluations.