Non-clinical safety evaluation of novel vaccines and adjuvants

New products, new strategies

Frank R. Brennan, Gordon Dougan

Research output: Contribution to journalReview ArticleResearchpeer-review

60 Citations (Scopus)

Abstract

Advances in molecular biology and biotechnology, coupled with an increased understanding of disease processes and mechanisms of protective immunity have facilitated the development of new rationally-designed vaccines utilising recombinant proteins, naked DNA, live vectors, genetically-modified toxins and whole dendritic and tumour cells for both prophylaxis and therapy of a wide range of indications. These new vaccine technologies coupled with novel adjuvants, delivery systems, formulations, dosing routes and regimes present many unique and difficult challenges in demonstrating product safety and efficacy to support clinical testing. This paper aims to review these novel vaccine and adjuvant technologies and to highlight the key safety issues potentially associated with them. Approaches taken to demonstrate vaccine safety by assessing systemic and local toxicity, biodistribution and persistence, immunogenicity and immunotoxicity, reproductive toxicology, safety pharmacology and genotoxicity within the current regulatory framework are presented.

Original languageEnglish
Pages (from-to)3210-3222
Number of pages13
JournalVaccine
Volume23
Issue number24
DOIs
Publication statusPublished - 2 May 2005
Externally publishedYes

Keywords

  • Adjuvant
  • Non-clinical safety testing
  • Vaccine

Cite this

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Non-clinical safety evaluation of novel vaccines and adjuvants : New products, new strategies. / Brennan, Frank R.; Dougan, Gordon.

In: Vaccine, Vol. 23, No. 24, 02.05.2005, p. 3210-3222.

Research output: Contribution to journalReview ArticleResearchpeer-review

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