Heplisav-B: genotox, carcinogenicity and repro: done or skipped?

“No genotoxicity was observed in the standard battery of tests composed of in vitro bacterial mutation, chromosome aberration and in vivo mouse erythrocyte micronucleus test.”

“No studies assessing the carcinogenicity of Heplisav B or 1018 ISS adjuvant have been performed. This is acceptable for this type of product in line with EMAs guidelines for vaccines and adjuvants and compliant with ICH S1A, considering that the exposure to this vaccine will be sporadic.”

“In a multigeneration reprotoxicological study in rats, effects on the offspring (stillborn pups and skeletal abnormalities) occurred secondary to maternal toxicity at a dose 200-fold the proposed clinical dose of Heplisav B with respect to 1018 ISS on a body weight basis.”

“No adverse effects were identified in 2 safety-pharmacology studies with doses of 1018 ISS up to 1.6 mg/kg in rabbits and 25 mg in baboons.”

“In conclusion, the test article 1018 ISS did not show any evidence or genotoxicity in this in vitro test for mutagenicity when tested up to the maximum concentration of 5 mg/plate.”

“In conclusion, the test article 1018 ISS did not show any evidence or genotoxicity in this in vitro test for induction of chromosome damage when tested up to the maximum concentration 5 mg/plate.”

“Therefore, 1018 ISS did not show any evidence of genotoxic activity and was found negative in the mouse micronucleus assay.”

“No studies assessing the carcinogenicity of Heplisav B or 1018 ISS adjuvant have been performed. This is acceptable for this type of product in line with EMAs guidelines for vaccines and adjuvants and compliant with ICH S1A, considering that the exposure to this vaccine will be sporadic.”

“No studies assessing the carcinogenicity of Heplisav B or 1018 ISS adjuvant have been performed. This is acceptable for this type of product in line with EMAs guidelines for vaccines and adjuvants and compliant with ICH S1A, considering that the exposure to this vaccine will be sporadic.”