Development of Vaccines for Microbial Diseases

Dennis W. Trent, David W C Beasley

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Development of new vaccines for prevention of microbial diseases continues to be a difficult, complex, time-consuming, and expensive venture for scientists in governments and commercial industry worldwide. The World Health Organization lists 15 infectious diseases that can now be controlled by immunization. Eradication of specific viral infections by vaccination (e.g., smallpox) has been successful, and immunization programs to eliminate human polio virus infection have made significant progress. Generally speaking, immunization is most likely to succeed for diseases where protective immunity follows natural infection. Infection with organisms that are highly variable (e.g., HIV and influenza) do not provide lasting immunity, and development of vaccines to prevent infection by highly complex organisms (e.g., malaria and most of the protozoan pathogens) continue to be unresolved. Development of vaccines to prevent infectious disease begins with identification of the organism that causes the infection and development of systems to propagate the agent in culture. Definition of "protective" antigen(s) and an understanding their chemistry and immunology are essential for vaccine development to proceed. The processes for development/manufacturing of vaccines are divided into two categories: upstream, which involves growth of the organism, and downstream purification with preparation of the purified vaccine product. During this process the vaccine is tested for potency, antigenicity, and purity to ensure safety. The ability of the vaccine to induce a protective immune response is evaluated and immunized animals challenged to determine efficacy. Experiments are included in the development plan to determine the optimal vaccine dose, toxicity, and stability. Data from all of these studies are incorporated into the Chemistry, Manufacturing, and Control section of the Investigational New Drug application submitted to a regulatory agency, such as the Food and Drug Administration when clinical trials with the vaccine are desired.

Original languageEnglish (US)
Title of host publicationVaccinology: An Essential Guide
PublisherWiley Blackwell
Pages192-211
Number of pages20
ISBN (Electronic)9781118638033
ISBN (Print)9780470656167
DOIs
StatePublished - Dec 9 2014

Fingerprint

Vaccines
Virus Diseases
Infection
Communicable Diseases
Investigational New Drug Application
Immunization
Immunization Programs
Smallpox
Poliomyelitis
United States Food and Drug Administration
Allergy and Immunology
Innate Immunity
Human Influenza
Malaria
Immunity
Industry
Vaccination
Clinical Trials
HIV
Safety

Keywords

  • Bulk drug product
  • Bulk drug substance
  • Efficacy
  • Good laboratory practice (GLP)
  • Good manufacturing processes (cGMP)
  • Immunogenicity
  • Master seeds
  • Potency
  • Quality control (QC)
  • Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Trent, D. W., & Beasley, D. W. C. (2014). Development of Vaccines for Microbial Diseases. In Vaccinology: An Essential Guide (pp. 192-211). Wiley Blackwell. https://doi.org/10.1002/9781118638033.ch11

Development of Vaccines for Microbial Diseases. / Trent, Dennis W.; Beasley, David W C.

Vaccinology: An Essential Guide. Wiley Blackwell, 2014. p. 192-211.

Research output: Chapter in Book/Report/Conference proceedingChapter

Trent, DW & Beasley, DWC 2014, Development of Vaccines for Microbial Diseases. in Vaccinology: An Essential Guide. Wiley Blackwell, pp. 192-211. https://doi.org/10.1002/9781118638033.ch11
Trent DW, Beasley DWC. Development of Vaccines for Microbial Diseases. In Vaccinology: An Essential Guide. Wiley Blackwell. 2014. p. 192-211 https://doi.org/10.1002/9781118638033.ch11
Trent, Dennis W. ; Beasley, David W C. / Development of Vaccines for Microbial Diseases. Vaccinology: An Essential Guide. Wiley Blackwell, 2014. pp. 192-211
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