Clinical Trials of Multivalent Opioid Vaccine Components

Description

Overview: The proposed study is designed as a Phase 1a/1b clinical trial of an oxycodone vaccine (Oxy(Gly)4-sKLH Conjugate Vaccine, Adsorbed). Healthy adults, aged 18 to 59 years, who meet DSM-5 criteria for OUD but are not seeking treatment for their drug use and are physically dependent on opioids will be recruited. This study will employ a between-groups, placebo-controlled design (two active vaccine doses, 1 placebo). Immunization will occur at Weeks 0, 3, 6 and 18. The Oxy(Gly)4-sKLH vaccine adsorbed to aluminum adjuvant (Alhydrogel®) or aluminum adjuvant as placebo, will be injected intramuscularly (IM) into the deltoid muscle. Each subject completing the study will participate for 42 weeks including: One Screening Phase (Weeks -6 to -2), an Outpatient Study Visit Phase (weeks 0-21), three Laboratory Session Phases (Week -1, Week 7 and Week 19), and an Extended Follow Up Phase (Weeks 23, 30, 34, 38, and 42).