Clin Exp Vaccine Res.  2015 Jan;4(1):46-53. 10.7774/cevr.2015.4.1.46.

Clinical vaccine development

• Han S

• KMID: 2049106
• DOI: http://doi.org/10.7774/cevr.2015.4.1.46

Abstract

Vaccination is regarded as one of the biggest triumphs in the history of medicine. We are living in the most successful period of vaccine development. The accumulation of multidisciplinary knowledge and the investment of massive funding have enabled the development of vaccines against many infectious diseases as well as other diseases including malignant tumors. The paradigm of clinical vaccine evaluation and licensure has also been modernized based on scientific improvements and historical experience. However, there remain a number of hurdles to overcome. Continuous efforts are focused on increasing the efficacy and reducing the risks related to vaccine use. Cutting-edge knowledge about immunology and microbiology is being rapidly translated to vaccine development. Thus, physicians and others involved in the clinical development of vaccines should have sufficient understanding of the recent developmental trends in vaccination and the diseases of interest.

Keyword

Vaccines; Vaccination; Clinical trial; History

MeSH Terms

Allergy and Immunology
Communicable Diseases
Financial Management
History of Medicine
Investments
Licensure
Vaccination
Vaccines
Vaccines

Figure

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  Fig. 1 Rise of vaccinology by Hilleman [1]. H. influenzae, Haemophilus influenzae.

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  Fig. 2 Current pathway of vaccine development. BLA, Biologic License Application; IND, investigational new drug; M USD, million United States dollars.

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  Fig. 3 Target population for vaccines in the 21st century by Rappuoli et al. [25]. (A) The most important vaccines for each age group are reported. (B) Special target groups for vaccination in the 21st century. The most important vaccines for each target group are reported. The lists of vaccines reported are indicative and are not intended to be exhaustive. C. difficile, Clostridium difficile; E. coli, Escherichia coli; EV71, enterovirus 71; H. influenzae, Haemophilus influenzae; K. pneumoniae, Klebsiella pneumoniae; P. aeruginosa, Pseudomonas aeruginosa; S. aureus, Staphylococcus aureus; AIDS, acquired immune deficiency syndrome; SARS, severe acute respiratory syndrome.

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