Naslov
Operating parameters influencing the non-clinical assessment of mumps virus immunogenicity in guinea pigs

Autori
Halassy, Beata ; Šantak, Maja ; Kurtović, Tihana ; Brgles, Marija ; Lang Balija, Maja ; Markušić, Maja ; Forčić, Dubravko

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
2012 Annual Meeting of Croatian Immunological Society. Book of Abstracts / - , 2012, 26-26

Skup
2012 Annual Meeting of Croatian Immunological Society

Mjesto i datum
Marija Bistrica, Hrvatska, 05.10.2012. - 06.10.2012

Vrsta sudjelovanja
Predavanje

Vrsta recenzije
Domaća recenzija

Ključne riječi
mumps virus; immunogenicity; Design of experiments

Sažetak
The quality of live attenuated viral vaccines has to be constantly evaluated from the two main aspects: safety and efficacy at the non-clinical level. The most suitable model for vaccine efficacy assessment today is evaluation of its ability to induce functional specific antibodies in small animals, i.e. its immunogenicity. The aim of this study was to assess the influence of several operating parameters that have been changing in the routine work on the results of immunogenicity testing of mumps viral vaccine in guinea pigs, and to settle the optimal operating conditions of the assay to give the most reliable results. Five operating parameters which are considered to be the potential source of the assay variability were identified, and their values for the two experimental levels were defined. Fractional factorial design of experiments (DOE) with resolution V was applied, and the specification for 16 experiments was obtained. The examined factors were the intervals between immunisations, the quantity of stabilizer (foetal calf serum) in the vaccine, the quantity of virus in the immunization dose, the body weight of guinea pigs, and the interval between the final immunization and the bleeding. Obtained results showed that the lower dose of virus quantity in the immunization dose was to low to induce functional antibodies measurable by used assays (neutralization of virus-induced cytopathic changes in vitro and inhibition of virus-induced agglutination of guinea-pig erythrocytes in vitro). From that reason the quantity of virus as an operating factor, although obviously important, could not be evaluated in this experiment and was ommited from analysis. The experimental plan involving the remaining four factors was recognized as the fractional factorial design of experiments with resolution IV and was used to calculate and evaluate their effects. It was shown that most significant effect on the assay outcome has interval between immunsations, following by the body weight of experimental animals.

Izvorni jezik
Engleski

Znanstvena područja
Biologija, Temeljne medicinske znanosti, Biotehnologija

POVEZANOST RADA