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Non-pertussis components of combination vaccines: problems with potency testing.
D Sesardic1, C S Dawes, K Mclellan
1Division of Bacteriology, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, EN6 3QG, U.K.
Summary
Combination vaccines, including diphtheria, tetanus, pertussis (DTP) and acellular pertussis (DTaP) formulations, require careful evaluation. Immunological interference between vaccine components can impact efficacy, safety, and stability, necessitating specific investigations.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Existing combination vaccines include diphtheria, tetanus, pertussis (DTP) with Haemophilus influenzae type b (Hib), inactivated poliovirus (IPV), and hepatitis B (HBV).
- Newer combination vaccines utilize acellular pertussis components (DTaP).
- The efficacy, safety, and stability of combination vaccines cannot be extrapolated from individual components or existing formulations.
Purpose of the Study:
- To investigate potential immunological interference between components in DTP and DTaP combination vaccines.
- To highlight the need for specific evaluation of combination vaccine performance.
Main Methods:
- Review of existing evidence from clinical trials and laboratory tests.
- Investigation of specific examples of immunological interference involving diphtheria (D), tetanus (T), and Hib components.
Main Results:
- Observed instances of immunological interference between vaccine components in both clinical and laboratory settings.
- Specific examples of interference involving D, T, and Hib components in DTP and DTaP vaccines have been identified.
Conclusions:
- Combination vaccines require rigorous assessment beyond data from individual components.
- Immunological interference is a critical factor affecting the performance of DTP and DTaP vaccines.
- Further research is essential to ensure the safety and efficacy of novel vaccine combinations.