title: Pre-registration efficacy study of a novel marker vaccine against classical swine fever on Maternally Derived Antibody negative (MDA-) target animals.
abstract: Classical swine fever (CSF) marker vaccine candidate CP7_E2alf produced under Good Laboratory Practice (GLP) conditions by Pfizer was tested on 40 six-week-old MDA-piglets according to the European Pharmacopoeia (Ph.Eur.) requirements. Single doses of CP7_E2alf were given to 15 piglets orally, while 15 other piglets were intramuscularly vaccinated. Ten additional animals were included as unvaccinated controls. All piglets were oronasally challenged with the highly virulent CSF virus (CSFV) strain "Koslov" 14 days after vaccination. CP7_E2alf administered i.m. provided a complete protection, while p.o. administratrion triggered only partial protection. The level of protection was determined by the development of clinical signs, viraemia and rate of mortality. The vaccine candidate met the criteria of Ph. Eur Monograph 0065, "Swine-fever vaccine (live, prepared in cell cultures), classical" 7th Edition, which claims the efficacy test is invalid if fewer than 50 per cent of the control piglets display typical signs of serious infection of CSF or die, and if fewer than 100 per cent of the control piglets show clinical signs of disease within 21 days following challenge. Fulfilling these validity criteria is a key step in the registration procedure for a vaccine candidate to become openly available.
authors: National Food Chain Safety Office, Directorate of Veterinary Medicinal Products, Budapest, Hungary.
authors: R
authors: R
authors: Lévai
authors: National Food Chain Safety Office, Directorate of Veterinary Medicinal Products, Budapest, Hungary.
authors: T
authors: T
authors: Barna
authors: National Food Chain Safety Office, Directorate of Veterinary Medicinal Products, Budapest, Hungary.
authors: K
authors: K
authors: Fábián
authors: Institute of Diagnostic Virology, Friedrich-Loeffler-Institut, Insel Riems, Germany.
authors: S
authors: S
authors: Blome
authors: National Veterinary Institute, Uppsala, Sweden.
authors: K
authors: K
authors: Belák
authors: National Food Chain Safety Office, Veterinary Diagnostic Directorate, Budapest, Hungary.
authors: Á
authors: Á
authors: Bálint
authors: Veterinary and Agrochemical Research Centre, Ukkel, Belgium.
authors: F
authors: F
authors: Koenen
authors: National Food Chain Safety Office, Directorate of Veterinary Medicinal Products, Budapest, Hungary.
authors: G
authors: G
authors: Kulcsár
authors: National Food Chain Safety Office, Directorate of Veterinary Medicinal Products, Budapest, Hungary. Electronic address: farsanga@nebih.gov.hu.
authors: A
authors: A
authors: Farsang
mesh_terms: D000818:Animals; D000914:Antibodies, Viral; D015415:Biomarkers; D006691:Classical Swine Fever / Q000276:immunology / Q000517:prevention & control; D006692:Classical Swine Fever Virus / Q000276:immunology*; D005260:Female; D008297:Male; D013552:Swine; D014765:Viral Vaccines / Q000276:immunology / Q000494:pharmacology
chemical_list: D000914:Antibodies, Viral; D015415:Biomarkers; D014765:Viral Vaccines
keywords: Classical swine fever; DIVA; European pharmacopoeia; Histopathology; Trial; Vaccine