Vaccine Toxicology

IITRI has extensive experience evaluating the safety and toxicity of a variety of vaccine types including inactivated live attenuated viral and bacterial preparations, plasmid DNA, nanoparticles, and viral vector vaccine candidates. We offer comprehensive GLP toxicology services including repeat-dose studies in rabbits, rodents and large animals (canine, ferret, and non-human primate/NHPs), biodistribution and immunogenicity studies. We also offer GLP vaccine toxicology studies in BSL-2 for select agent studies.

Vaccine Toxicology Studies

  • Single and repeat dose
  • Immunogenicity
  • Genotoxicity and carcinogenicity (adjuvants and additives)
  • Reproductive toxicology
  • Safety pharmacology
  • PK/biodistribution
  • Clinical pathology and histopathology
  • Immunological and virological assays including: ELISA, PCR, 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 HPV vaccine Mice
Toxicity Staphylococcus vaccine Rabbits
Toxicity Streptococcus vaccines Rabbits
Toxicity West Nile vaccine Rats
Toxicity Malaria vaccine Rabbits
Toxicity Schistosomiasis vaccines Rats and rabbits
Toxicity Leishmaniasis vaccines Rabbits
Toxicity Filovirus vaccine Rabbits
Immunogenicity Small pox vaccine candidates Immunocompromised mice
Toxicity Plague vaccines Rabbits
Toxicity Tularemia vaccines Rabbits
Toxicity Ricin vaccine Rabbits

The IITRI Advantage

  • Direct interaction with PhD, DABT study directors
  • A highly experienced and integrated study team from a broad range of disciplines including toxicology, virology, bacteriology, immunology and molecular biology
  • BSL-2/3+ facilities for vaccine toxicology studies that require containment
  • Flexible, collaborative approach to study design to optimize cost and quality
  • Comprehensive preclinical vaccine toxicology programs available to support IND and NDA submissions