A Method for Individualizing the Prediction of Immunogenicity of Protein Vaccines and Biologic Therapeutics: Individualized T Cell Epitope Measure (iTEM)

Table 1

Design of six different studies used to validate the iTEM predictions. In three cases, inbred HLA transgenic mice were used for measurements of vaccine immunogenicity. In the other three, human subjects were recruited for evaluations of immune responses to protein antigens.

Study	Subject	Immunization	Boost
Tularemia	HLA Transgenic Mice	DNA vector IN	Peptides IN
Smallpox	HLA Transgenic Mice	DNA vector IM	Peptides SC
Tuberculosis	HLA Transgenic Mice	Peptide IN	Peptides
T1D	Humans	Natural Autoimmunity	Peptides ex vivo
FPX	Humans	Protein IV or SC	None
Tularemia	Humans	Natural Infection	None