Clinical Trials of Multivalent Opioid Vaccine Components

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.

Conditions

• Opioid-use Disorder

Interventions

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

Sponsors & Collaborators

• Clinilabs, Inc.

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• New York State Psychiatric Institute

  lead OTHER

Principal Investigators

• Sandra D Comer, PhD · New York State Psychiatric Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-08

Primary Completion

2027-03-30

Completion

2027-03-30

FDA Drug

Yes

Countries

• United States

Study Locations