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Typhoid vaccine conjugate ViDT is a new vaccine and under development, <br /> <br /> therefore it is important to study critical factors that might affect its production. <br /> <br /> The aim of this study was to evaluate the effects of variations in concentration, <br /&...
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Format: | Theses |
Language: | Indonesia |
Online Access: | https://digilib.itb.ac.id/gdl/view/25788 |
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Institution: | Institut Teknologi Bandung |
Language: | Indonesia |
Summary: | Typhoid vaccine conjugate ViDT is a new vaccine and under development, <br />
<br />
therefore it is important to study critical factors that might affect its production. <br />
<br />
The aim of this study was to evaluate the effects of variations in concentration, <br />
<br />
pH, storage time and temperature on the molecular size of Vi polysaccharide, <br />
<br />
ViDT conjugate and typhoid conjugate vaccine to support the development of <br />
<br />
typhoid conjugate vaccine. Three batches of pilot scale production of Vi <br />
<br />
polysaccharide, ViDT conjugate and typhoid conjugate vaccine were tested for <br />
<br />
stability, storage temperature and pH against molecular size using the HPLC <br />
<br />
method. The particle size and microscopic of the ViDT conjugate caused by <br />
<br />
variation on the concentrations were evaluated by dynamic light scattering and <br />
<br />
scanning electron microscope, repectively. . The results of Vi polysaccharide <br />
<br />
molecule was stable in the storage for 3 months at temperature 2-8 °C, and did <br />
<br />
not affected by pH and freeze thaw. The molecular size of ViDT conjugate <br />
<br />
was stable in the storage for 3 months at 2-8 °C and 25 °C, but its molecular <br />
<br />
size was unstable in temperature of -20 °C. Change in pH did affect the <br />
<br />
molecular size of ViDT. Increasing concentrations of ViDT up to 4 times <br />
<br />
resulted an increase in molecular size and particle size, which confirmed by <br />
<br />
microscopic results. However, the increase did not statistically significant. The <br />
<br />
molecular size of typhoid conjugate vaccine was stable in the storage for 3 <br />
<br />
months at 2-8 °C and 25 °C, but there was signifficant change in molecular size <br />
<br />
at 37 °C. The molecular size of the typhoid conjugate vaccine was affected by <br />
<br />
pH. Variations in the initial concentrations of ViDT did not affect the molecular <br />
<br />
size of the typhoid conjugate vaccine. <br />
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