TABLE 3.

Preclinical studies for the p62 vaccine safety.

Study	Animals/doses	Conclusion
Acute i.m. and i.p. toxicity	Rats, mice, guinea pigs 1, 5, 10, 50 ETD	No acute toxicity observed
Chronic toxicity upon i.m. daily administration for 90 days	Rats –1,5,10, 50 ETD	Low hazard
	Dogs –1, 10 ETD	Low toxicity
Allergic activity	Guinea pigs, 1, 10 ETD	No anaphylactic shock or local allergic reaction
Immunological safety	Mice, 1,10 ETD, 5 times i.m	No effect on B- and T-cell response
Embryotoxicity and teratogenicity	Rats, 1, 10 ETD, 5-times i.m.	No embryotoxicity or teratogenicity

ETD—effective therapeutic dose.