Heplisav-B: how long were the pivotal tox studies?

“rats or cynomolgus monkey received subcutaneously (SC) either 0.5, 1.5, 12.5 mg/kg/week of 1018 ISS adjuvant or PBS weekly for 8 weeks.”

“The general safety of the 1018 ISS adjuvanted HBsAg vaccine was investigated in two pivotal studies were the vaccine was administrated by the IM injection, the clinical route of administration: a repeated-dose toxicity study in mice (study 00-95) where 3 IM doses were given (at day 0, 14 and 28) and a repeated dose toxicity study in rats (study 12-728) where 4 IM doses were given (at day 0, 14, 28 and 42).”

“Of importance, no kidney or heart findings were observed in monkeys or in the rat study of 1018 ISS adjuvanted HBsAg administered with a dosing regimen (4 IM every second week) more similar to the clinical dosing regimen of 2 IM doses 1 month apart than in the rat study of 1018 ISS alone (8 SC doses every week).”