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IITRI has over 15 years of experience conducting GLP-compliant vaccine safety and toxicity studies on a variety of vaccine types including inactivated and live attenuated viral and bacterial preparations, plasmid DNA, nanoparticles, and viral vector immunotherapies, as well as adjuvanted vaccines.
We offer comprehensive GLP vaccine toxicology services including repeat-dose studies in rabbits, rodents and large animals (canine, ferret, and non-human primate/NHPs), biodistribution, and immunogenicity studies to meet FDA submission guidelines. We also offer GLP vaccine toxicology studies in ABSL-2 facilities for studies on live attenuated viral vaccines against infectious agents or as cancer vaccine immunotherapies.
Vaccine Toxicity Studies
- Single and repeat dose
- Clinical pathology and histopathology
- Immunological and virological in vitro assays including: ELISA, qPCR, hemagglutination inhibition assay, and microneutralization assays
Vaccine Toxicology Experience
|Study Type||Vaccine||Animal Model|
|Toxicity/immunogenicity||H5N1 influenza vaccine||Rabbits|
|Toxicity||H1N1 influenza vaccine||Rabbits|
|Toxicity||Attenuated measles virus||Squirrel monkeys|
|Toxicity||Dengue vaccine||Immunocompromised mice|
|Toxicity||West Nile vaccine||Rats|
|Toxicity||Schistosomiasis vaccines||Rats and rabbits|
|Immunogenicity||Small pox vaccine candidates||Immunocompromised mice|