REGULATORY LANDSCAPE FOR VETERINARY VACCINES

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ECONOMIC IMPACT OF ANIMAL DISEASES AND THEIR CONTROL IN LIVESTOCK PRODUCTION: ROLE OF VACCINES

Animal production serves multiple purposes worldwide. Livestock production and rearing is an important part of the economy of many countries and is considered to be the greatest contributor o the livelihood of the majority of the poor around the world (Perry et al., 2002). Animal products for human consumption are also a major contributor to the quality of human nutrition. Animal protein is of higher biological value than plant proteins and it supplies many essential nutrients, such as vitamin A and iron, which are often inadequate in rural diets. Moreover, milk and dairy products are recognized as the most balanced food for humans and, in some rural areas, access to quality proteins in the diet is only by means of ingesting animal products (Perry et al., 2002).
The role of livestock in the economy can be illustrated in the South African context. The country is water scarce with only 13% of the land arable and suitable for crop production. The rest is distributed between human settlement and animal farming (intensive and extensive, representing 9% of the total land). Animal farming occupies almost 80% of the agricultural land utilization, and livestock products account for between 37% and 41% of the total value of agricultural output (Anon., 2005). Although primary agriculture products (e.g. milk, meat, wool and crops) constitute 4-5% of the gross domestic product (GDP), a very large secondary industry exists, which, for primary animal products, include the distribution and marketing of primary products, processing industry, clothing industry (e.g. wool and leather), biopharmaceutical industry and entertainment (horse racing).
The steady development in animal production and subsequent food security has been for centuries hampered by health conditions and diseases, of which infectious diseases have played a major role. Over the past ten years, a number of infectious diseases outbreaks have resulted in serious financial losses that have impacted on national, regional and global economies (Anon., 2002), as illustrated in Tables 1.1 and 1.2.

CHAPTER ONE LITERATURE REVIEW
1.1 ECONOMIC IMPACT OF ANIMAL DISEASES AND THEIR CONTROL IN LIVESTOCK PRODUCTION: ROLE OF VACCINES
1.2 HISTORY OF VACCINES AT ONDERSTEPOORT
1.3 VETERINARY VACCINOLOGY AND ADVANCES IN VACCINE TECHNOLOGY
1.3.1 General veterinary vaccinology
1.3.2 Conventional vaccines
1.3.3 New vaccine technology
1.4 VACCINE DELIVERY AND VACCINE ADJUVANTS
1.4.1 Development of immune response to vaccines and adjuvants
1.4.2 Mechanism of action and effect of adjuvants
1.4.3 Types of adjuvants
1.5 OIL ADJUVANTS AND THEIR USE IN VACCINES
1.6 OIL VACCINES USED IN THIS STUDY
1.6.1 Pulpy kidney vaccine
1.6.2 Vibrio (Campylobacter fetus) vaccine
1.6.3 Escherichia coli vaccine
1.6.4 Infectious coryza vaccine
1.7 REGULATORY LANDSCAPE FOR VETERINARY VACCINES
1.8 PURPOSE OF THE THESIS
1.9 SPECIFIC OBJECTIVES OF THIS STUDY
1.10 REFERENCES
CHAPTER TWO  STUDY OF MINERAL OILS USED IN THE FORMULATION OF THE ONDERSTEPOORT BIOLOGICAL PRODUCTS (OBP) INFECTIOUS CORYZA AND PULPY KIDNEY OIL VACCINES
2.1 INTRODUCTION
2.2 MATERIALS AND METHODS
2.2.1 Liquid paraffins
2.2.2 Viscosity testing
2.2.3 Safety in experimental animals
2.2.4 Purity test by means of Nuclear Magnetic Resonance (NMR) spectroscopy
2.2.5 Emulsifiability and stability of emulsion produced
2.3 RESULTS
2.3.1 Viscosity of the liquid paraffins
2.3.2 Safety of the liquid paraffins in experimental animals
2.3.3 Purity of the liquid paraffins
2.3.4 Emulsifiability and stability of emulsions produced
2.4 DISCUSSION
2.5 REFERENCES
CHAPTER THREE STUDY OF EMULSIFIERS USED IN THE FORMULATION OF ONDERSTEPOORT BIOLOGICAL PRODUCTS (OBP) VIBRIOSIS, Escherichia coli and PULPY KIDNEY OIL VACCINES
3.1 INTRODUCTION
3.2 MATERIALS AND METHODS
3.2.1 Emulsifiers
3.2.2 Formulations of emulsions and experimental vaccines
3.2.3 Evaluation of vaccine emulsions
3.2.4 Animal experiments
3.2.5 Assays for evaluation of the potency of different vaccines
3.3 RESULTS AND DISCUSSION
3.3.1 Evaluation of stability characteristics of Simulsol-P2®
3.3.2 Evaluation of Cirrasol EN-MP® versus Arlacel C and Montanide 103™
3.4 REFERENCES
CHAPTER FOUR  STUDY ON THE EFFICACY AND SAFETY OF DIFFERENT ANTIGENS AND OIL FORMULATIONS OF INFECTIOUS CORYZA VACCINES CONTAINING A NAD INDEPENDENT STRAIN OF Avibacteriuparagallinarum
4.1 INTRODUCTION
4.2 MATERIALS AND METHODS
4.2.1 Vaccines
4.2.2 Chickens
4.2.3 Bacterial isolates used for challenge
4.2.4 Vaccination and challenge experiments
4.3 RESULTS
4.3.1 Stability of the experimental IC oil vaccines
4.3.2 Post-vaccinal safety of the vaccines
4.3.3 Efficacy of the vaccine formulations to different serovars after first challenges
4.4 DISCUSSION
4.5 REFERENCES
CHAPTER FIVE CONCLUDING REMARKS

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