Toxicology testing in minipigs of a heroin vaccine intended for clinical treatment of opioid use disorder

Abstract ID 125919 Poster Board 092 A heroin vaccine (M-sKLH adsorbed to aluminum and adjuvanted with a TLR7/8 agonist INI-4001) is being developed for clinical evaluation to treat opioid use disorder (OUD) and has shown pre-clinical efficacy in rodents. Manufacturing of the heroin vaccine is underway, and the vaccine is currently undergoing toxicology assessment following biweekly injections (on Day 1, 15, 29, and 43) of low and high doses of vaccine (with and without the INI-4001 adjuvant) in male and female Göttingen minipigs (n=10/group). No adverse clinical signs and no dermal changes at the site of injection were observed following administration of all vaccine doses in any group. The highest morphine-specific serum IgG titers were observed in the group that received vaccine adjuvanted with INI-4001, and higher antibody titers were observed in the high vaccine dose group compared to the lower dose group. Group weights and food consumption did not differ between groups following administration of control or any vaccine group. These data demonstrate that M-sKLH adjuvanted with aluminum and INI-4001 is well tolerated and elicits high antibody levels in minipigs, suggesting that this vaccine formulation is safe for use in humans. This work was supported by NIDA under UG3/UH3 DA047711 (MP) and NIAID under BAA-DAIT-75N93019R00009 (MP).