Pregled bibliografske jedinice broj: 770386
Factors influencing preclinical in vivo evaluation of mumps vaccine strain immunogenicity
Factors influencing preclinical in vivo evaluation of mumps vaccine strain immunogenicity // Human Vaccines & Immunotherapeutics, 11 (2015), 10; 2446-2454 doi:10.1080/21645515.2015.1062191 (međunarodna recenzija, članak, znanstveni)
CROSBI ID: 770386 Za ispravke kontaktirajte CROSBI podršku putem web obrasca
Naslov
Factors influencing preclinical in vivo evaluation of mumps vaccine strain immunogenicity
Autori
Halassy, Beata ; Kurtović, Tihana ; Brgles, Marija ; Lang Balija, Maja ; Forčić, Dubravko
Izvornik
Human Vaccines & Immunotherapeutics (2164-5515) 11
(2015), 10;
2446-2454
Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni
Ključne riječi
Mumps virus ; Non-clinical vaccine immunogenicity assessment ; In vivo bioassay optimization ; Design of Experiments (DoE)
Sažetak
Immunogenicity testing in animals is a necessary preclinical assay for demonstration of vaccine efficacy the results of which are often the basis for the decision whether to proceed or withdraw the further development of the novel vaccine candidate. However, in vivo assays are rarely, if at all, optimized and validated. Here we clearly demonstrate the importance of in vivo assay (mumps virus immunogenicity testing in guinea pigs) optimization for gaining reliable results and the suitability of Fractional factorial design of experiments (DoE) for such a purpose. By the use of DoE with resolution IV (2IV(4-1)) we clearly revealed that the parameters significantly increasing assay sensitivity were interval between animal immunisations followed by the body weight of experimental animals. The quantity (0 versus 2%) of the stabilizer (foetal bovine serum, FBS) in the sample was shown as non-influencing parameter in DoE setup. However, the separate experiment investigating only the FBS influence, and performed under other parameters optimally set, showed that FBS also influences the results of immunogenicity assay. Such finding indicated that (a) factors with strong influence on the measured outcome can hide the effects of parameters with modest/low influence and (b) the matrix of mumps virus samples to be compared for immunogenicity must be identical for reliable virus immunogenicity comparison. Finally the three mumps vaccine strains widely used for decades in the licenced vaccines were for the first time compared in an animal model, and results obtained were in line with their reported immunogenicity in human population supporting the predictive power of the optimized in vivo assay.
Izvorni jezik
Engleski
Znanstvena područja
Biologija, Biotehnologija
POVEZANOST RADA
Projekti:
021-0212432-2033 - Imunogeničnost komponenti kompleksnih antigena (Halassy, Beata, MZOS ) ( CroRIS)
HRZZ-UIP-2013-11-8193 - Kromatografsko pročišćavanje biomolekula i njihova karakterizacija (CHROBIO) (Brgles, Marija, HRZZ - 2013-11) ( CroRIS)
Ustanove:
Imunološki zavod d.d.,
Sveučilište u Zagrebu
Profili:
Marija Brgles
(autor)
Beata Halassy
(autor)
Dubravko Forčić
(autor)
Tihana Kurtović
(autor)
Maja Lang Balija
(autor)
Citiraj ovu publikaciju:
Časopis indeksira:
- Current Contents Connect (CCC)
- Web of Science Core Collection (WoSCC)
- Science Citation Index Expanded (SCI-EXP)
- SCI-EXP, SSCI i/ili A&HCI
- Scopus
- MEDLINE