Elsevier

Biologicals

Volume 27, Issue 2, June 1999, Pages 177-181
Biologicals

Regular Article
Non-pertussis Components of Combination Vaccines: Problems with Potency Testing

https://doi.org/10.1006/biol.1999.0205Get rights and content

Abstract

Vaccines comprising combinations of diphtheria, tetanus and pertussis (DTP) with Haemophilus influenzae type b polysaccharide–protein conjugate (Hib), inactivated poliomyelitis virus (IPV) and hepatitis B virus (HBV) are already available, and new combinations using acellular pertussis components in a triple vaccine (DTaP) are under development. Evidence to date has shown that control of the efficacy, safety and stability of combination vaccines cannot be based on information already available on the individual components or existing licensed formulations. Several examples of immunological interference between components of a combination vaccine have been observed both in clinical trials and in laboratory tests. Examples of these for D, T and Hib components in DTP and DTaP combinations have been investigated.

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  • An experimental divalent vaccine based on biodegradable microspheres induces protective immunity against tetanus and diphtheria

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    Furthermore, the protective efficacy of microsphere-based vaccines has not always been adequately confirmed. Although several investigations2,4–6 have demonstrated the induction of neutralizing antibodies (nAb) and nAb against tetanus and diphtheria toxins generally correlate well with protection in the guinea pig model for currently licensed vaccines,12,13 protective immunity is ideally demonstrated by a direct challenge with the infectious agent. Multivalent vaccines based on slowly degradable microspheres have the potential to improve immunization compliance and coverage, especially in developing countries, and their implementation in vaccine-production strategies is highly attractive.

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