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Regulations and procedures in parasite vaccine development

Published online by Cambridge University Press:  02 February 2007

TH. P. M. SCHETTERS  and
M. GRAVENDYCK
TH. P. M. SCHETTERS
Affiliation:
Parasitology R&D Department, Intervet International, P.O. Box 31, 5830 AA, Boxmeer, The Netherlands
M. GRAVENDYCK
Affiliation:
Registration Department, Intervet International, P.O. Box 31, 5830 AA, Boxmeer, The Netherlands
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Abstract

Although immunisation protocols for a wide variety of parasitic diseases have been developed, it is often questioned why these do not always reach the market. In this review information about the regulations and procedures that apply to licensing the production and marketing of medicinal preparations, especially parasite vaccines, is presented. These general regulations specify issues on product (quality, safety, efficacy and potency) and production (facilities and consistency). Vaccine developers and manufacturers have to comply with these regulations, which may involve years of research and development. Moreover, where the manufacturer claims specific features of the product, these claims have to be corroborated by (experimental) data. A series of principles has been used to develop vaccines against parasite infections varying from the use of (attenuated) live vaccines to killed vaccines and subunit vaccines. The implications of some specific regulatory issues associated with these approaches are discussed.

Keywords

Vaccinedevelopmentmanufacturerequirementsguidelinesparasite
Type
Research Article
Information
Parasitology , Volume 133 , Supplement S2: Parasite Vaccines , October 2006 , pp. S189 - S195
Copyright
© 2006 Cambridge University Press

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References

REFERENCES

Brunko, P. ( 1997). Part 3. Procedures and technical requirements in the European Union. In Veterinary Vaccinology ( ed. Pastoret, P.-P., Blancou, J., Vannier, P. and Verschueren, C.), pp. 674–679. Elsevier, Amsterdam.
Buxton, D. ( 1993). Toxoplasmosis: the first commercial vaccine. Parasitology Today 9, 335–337.CrossRefGoogle Scholar
Cornelissen, A. W. C. A. and Schetters, Th. P. M. ( 1996). Vaccines against protozoal diseases of veterinary importance. FEMS Immunology and Medical Microbiology 15, 61–72.CrossRefGoogle Scholar
Dalton, J. P. and Mulcahy, G. ( 2001). Parasite vaccines – A reality? Veterinary Parasitology 98, 149–167.Google Scholar
De Waal, D. T. and Combrink, M. P. ( 2006). Live vaccines against babesiosis. Veterinary Parasitology 138, 88–96.CrossRefGoogle Scholar
Espeseth, D. ( 1997). Part 4. Procedures and norms in the United States. In Veterinary Vaccinology ( ed. Pastoret, P.-P., Blancou, J., Vannier, P. and Verschueren, C.), pp. 680–686. Elsevier, Amsterdam.
Harrison, G. B., Shakes, T. R., Robinson, C. M., Lawrence, S. B., Heath, D. D., Dempster, R. P., Lightowlers, M. W. and Rickard, M. D. ( 1999). Duration of immunity, efficacy and safety in sheep of a recombinant Taenia ovis vaccine formulated with saponin or selected adjuvants. Veterinary Immunology and Immunopathology 20, 161–172.CrossRefGoogle Scholar
Marcotty, T., Billiouw, M., Chaka, G., Berkvens, D., Losson, B. and Brandt, J. ( 2001). Immunisation against East Coast Fever by the infection and treatment method: evaluation of the use of ice baths for field delivery and appraisal of an acid formulation of long-acting tetracycline. Veterinary Parasitology 99, 175–187.CrossRefGoogle Scholar
Noguiera, F. S., Moreira, M. A. B., Borja-Cabrera, G. P., Santos, F. N., Menz, I., Parra, L. E., Xu, Z., Chu, H. J., Palatnik-de-Sousa, C. B. and Luvizotto, M. C. R. ( 2005). Leishmune® vaccine blocks the transmission of canine visceral leishmaniasis. Absence of Leishmania parasites in blood, skin and lymph nodes of vaccinated exposed dogs. Vaccine 23, 4805–4810.CrossRefGoogle Scholar
Olson, M. E., Ceri, H. and Morck, D. W. ( 2000). Giardia vaccination. Trends in Parasitology 16, 213–217.CrossRefGoogle Scholar
Schetters, Th. P. M. ( 1995). Vaccine development from a commercial point of view. Veterinary Parasitology 57, 267–275.CrossRefGoogle Scholar
Schetters, Th. P. M. ( 2004). Intervet Symposium Bovine Neosporosis. Veterinary Parasitology 125, 137–146.Google Scholar
Schetters, Th. P. M. ( 2005). Vaccination against canine babesiosis. Trends in Parasitology 21, 179–184.CrossRefGoogle Scholar
Schijns, V. E. and Tangeras, A. ( 2005). Vaccine adjuvant technology: from theoretical mechanisms to practical approaches. Developmental Biology 121, 127–134.Google Scholar
Shkap, V. and Pipano, E. ( 2000). Culture-derived parasites in vaccination of cattle against tick-borne diseases. Annals of the New York Academy of Sciences 916, 154–171.CrossRefGoogle Scholar
Sutkowsky, E. M. and Gruber, M. F. ( 2006). Regulatory considerations in the non-clinical safety assessment of adjuvanted preventive vaccines. In Immunopotentiators in Modern Vaccines ( ed. Schijns, V. E. J. C. and O'Hagan, D. T.), pp. 343–359. Elsevier Academic Press, London.
Urquhart, G. M. ( 1985). Field experience with the bovine lungworm vaccine. Developments in Biological Standardization 62, 109–112.Google Scholar
Vercruysse, J., Knox, D. P., Schetters, Th. P. M. and Willadsen, P. ( 2004). Veterinary parasitic vaccines: Pitfalls and future directions. Trends in Parasitology 20, 488–492.CrossRefGoogle Scholar
Vermeulen, A. N., Schaap, D. C. and Schetters, Th. P. M. ( 2001). Control of coccidiosis in chickens by vaccination. Veterinary Parasitology 100, 13–20.CrossRefGoogle Scholar
Wallach, M., Smith, N. C., Petracca, M., Miller, C. M. D., Eckert, J. and Braun, R. ( 1995). Eimeria maxima gametocyte antigens: Potential use in a subunit maternal vaccine against coccidiosis in chickens. Vaccine 13, 347–354.CrossRefGoogle Scholar
Willadsen, P. ( 2004). Anti-tick vaccines. Parasitology 129 (Suppl.), S367–S387.CrossRefGoogle Scholar
Williams, R. B. ( 1994). Safety of the attenuated anticoccidial vaccine Paracox in broiler chickens isolated from extraneous coccidial infection. Veterinary Research Communications 18, 189–198.CrossRefGoogle Scholar
Williams, R. B. ( 2002). Anticoccidial vaccines for broiler chickens: pathways to success. Avian Pathology 31, 317–353. Review (2003); Erratum in Avian Pathology 32, 429.CrossRefGoogle Scholar