NCT04458545

Clinical Trials of Multivalent Opioid Vaccine Components

Phase 1A/1B Clinical Trials of Multivalent Opioid Vaccine Components

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

Currently, abuse of prescription opioid analgesics and heroin is a serious problem in the U.S. Although several medications, including methadone, buprenorphine, and naltrexone, are available and effective in treating opioid use disorder (OUD), long-term relapse rates remain high. The current study is designed to examine a new approach to treating OUD, namely use of a vaccine targeted against oxycodone \[Oxy(Gly)4-sKLH\], one of the most commonly abused prescription opioids. The vaccination approach to treating substance use disorders relies on the ability of the vaccine to produce antibodies that bind the target drug in blood and reduce its ability to enter the brain. The long-term goal of this research will be to develop a combined vaccine against oxycodone and heroin. However, in this trial the Oxy(Gly)4-sKLH vaccine will be studied separately. This is a multi-site study, being conducted at the New York State Psychiatric Institute and the Clinilabs clinical research unit (CRU) in Eatontown, New Jersey. The current study proposes to evaluate safety (Aim 1), degree of antibody production (Aim 2), and efficacy (i.e., ability to reduced drug liking following opioid administration) (Aim 3). The oxycodone vaccine (Oxy(Gly)4-sKLH) will be tested in participants with OUD (target # completers = 45 across two study sites). This study will provide a great deal of information about the safety and potential effectiveness of the Oxy(Gly)4-sKLH vaccine in reducing the abuse of opioids. The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.

Detailed 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).

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Oxy(Gly)4-sKLH vaccine - Low Dose	Oxy(Gly)4-sKLH vaccine - Low Dose
BIOLOGICAL	Oxy(Gly)4-sKLH vaccine - High Dose	Oxy(Gly)4-sKLH vaccine - high dose
BIOLOGICAL	Placebo Oxy(Gly)4-sKLH vaccine	Oxy(Gly)4-sKLH vaccine - Placebo

Timeline

• Start date: 2020-10-08
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2020-07-07
• Last updated: 2025-05-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study