Stability-related studies on 17D yellow fever vaccine

Autor: Guy Girault, Moreau Jp, Ronald Perraut
Přispěvatelé: Institut Pasteur de Dakar, Réseau International des Instituts Pasteur (RIIP)
Jazyk: angličtina
Rok vydání: 2000
Předmět:
Veterinary medicine
Time Factors
MESH: Quality Control
0302 clinical medicine
Vaccine strain
Drug Stability
MESH: Animals
030212 general & internal medicine
Degradation test
Cells
Cultured
MESH: Yellow Fever
Attenuated vaccine
MESH: Drug Storage
biology
Yellow fever
Temperature
MESH: Temperature
3. Good health
MESH: Reproducibility of Results
Flavivirus
Infectious Diseases
[SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology
Biological Assay
Yellow fever virus
medicine.drug
MESH: Cells
Cultured
Quality Control
Stability study
Drug Storage
030231 tropical medicine
Immunology
Yellow fever vaccine
Vaccines
Attenuated
MESH: Biological Assay
Microbiology
03 medical and health sciences
Flaviviridae
MESH: Viral Vaccines
MESH: Drug Stability
Yellow Fever
MESH: Vaccines
Attenuated
medicine
Animals
MESH: Time Factors
Reproducibility of Results
Viral Vaccines
biology.organism_classification
medicine.disease
Virology
MESH: Yellow fever virus
[SDV.IMM.VAC]Life Sciences [q-bio]/Immunology/Vaccinology
Zdroj: Microbes and Infection
Microbes and Infection, Elsevier, 2000, 2 (1), pp.33-8. ⟨10.1016/S1286-4579(00)00288-4⟩
ISSN: 1286-4579
Popis: International audience; Yellow fever (YF) vaccine using the 17D strain of YF attenuated virus has been produced at the Institut Pasteur in Dakar since 1962. Until now, the stabilised YF had an expiry date of utilization of two years from the end of the lot control process under storage at +4 degrees C. We conducted a stability study to assess the three full year validity of this preparation, when correctly stored at +4 degrees C to optimise the conditions of production, storage and availability of such a vaccine. The activity of 19 consecutive batches of vaccines kept for three years at +4 degrees C was compared to that of the same batches that were kept three years at -20 degrees C. Using the in vitro microculture method, we found that three-year storage at +4 degrees C induced a higher loss of activity than storage at -20 degrees C or than the accelerated degradation test of vaccines kept for 14 days at 37 degrees C. Whatever the conditions of storage, in all cases decreases in activity were below the WHO's requirements, i.e., < 1 log PFU/dose, and residual activity of the selected batches was over 1000 mouse LD50 per dose. We demonstrated that the 17D YF vaccine produced in Dakar has a shelf-life of three years and that its required potency was maintained at +4 degrees C, after reconstitution with saline diluent, following three-year storage at +4 degrees C.
Databáze: OpenAIRE
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