Clinical Trials of Multivalent Opioid Vaccine Components
- Conditions
- Opioid-use Disorder
- Interventions
- Biological: Oxy(Gly)4-sKLH vaccine - Low DoseBiological: Placebo Oxy(Gly)4-sKLH vaccineBiological: Oxy(Gly)4-sKLH vaccine - High Dose
- Registration Number
- NCT04458545
- Lead Sponsor
- New York State Psychiatric Institute
- Brief 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Vaccine (high dose or low dose) Oxy(Gly)4-sKLH vaccine - Low Dose Active Oxy(Gly)4-sKLH vaccine dose (low dose or high dose) Active Vaccine (high dose or low dose) Oxy(Gly)4-sKLH vaccine - High Dose Active Oxy(Gly)4-sKLH vaccine dose (low dose or high dose) Placebo Oxy(Gly)4-sKLH vaccine dose Placebo Oxy(Gly)4-sKLH vaccine Placebo Oxy(Gly)4-sKLH vaccine
- Primary Outcome Measures
Name Time Method Effects of Vaccine on Intranasal Drug Positive Subjective Effects Throughout the testing session [i.e., pre-dose baseline (Time 0)- Thru- 4.5 hours post-dose]. Peak self-reported drug "Liking." Measured using a visual analog scale (0-100).
Incidence of Treatment-Emergent Adverse Events Beginning from first vaccination through study completion (43 Weeks). Safety and tolerability of the opioid vaccine.
Immune response to Oxy(Gly)4-sklh Baseline, Weeks 0-8, Weeks 10, 12, 14, 18, 19, 20, 23, 34, 42 Antibody titers, concentrations, affinity for oxycodone, cross-reactivity to off-target opioid agonists and antagonists (including endogenous opioid neuropeptides), and subclasses of the serum IgG antibodies will be measured at baseline and repeatedly over the course of the study period to characterize the magnitude and duration of the antibody response to vaccination.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Clinilabs Drug Development Corporation
🇺🇸Eatontown, New Jersey, United States
New York State Psychiatric Institute: Division on Substance Use Disorders
🇺🇸New York, New York, United States