Clinical Trials of Multivalent Opioid Vaccine Components

NCT04458545 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 7712 ; 00076633
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events

  Safety and tolerability of the opioid vaccine.

  Beginning from first vaccination through study completion (43 Weeks).

• Immune response to Oxy(Gly)4-sklh

  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.

  Baseline, Weeks 0-8, Weeks 10, 12, 14, 18, 19, 20, 23, 34, 42

• Effects of Vaccine on Intranasal Drug Positive Subjective Effects

  Peak self-reported drug "Liking." Measured using a visual analog scale (0-100).

  Throughout the testing session [i.e., pre-dose baseline (Time 0)- Thru- 4.5 hours post-dose].

Study Arms (2)

Active Vaccine (high dose or low dose)

EXPERIMENTAL

Active Oxy(Gly)4-sKLH vaccine dose (low dose or high dose)

Biological: Oxy(Gly)4-sKLH vaccine - Low Dose; Biological: Oxy(Gly)4-sKLH vaccine - High Dose

Placebo Oxy(Gly)4-sKLH vaccine dose

PLACEBO COMPARATOR

Placebo Oxy(Gly)4-sKLH vaccine

Biological: Placebo Oxy(Gly)4-sKLH vaccine

Interventions

Oxy(Gly)4-sKLH vaccine - Low Dose BIOLOGICAL

Oxy(Gly)4-sKLH vaccine - Low Dose

Active Vaccine (high dose or low dose)

Oxy(Gly)4-sKLH vaccine - High Dose BIOLOGICAL

Oxy(Gly)4-sKLH vaccine - high dose

Active Vaccine (high dose or low dose)

Placebo Oxy(Gly)4-sKLH vaccine BIOLOGICAL

Oxy(Gly)4-sKLH vaccine - Placebo

Placebo Oxy(Gly)4-sKLH vaccine dose

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Participation in a clinical trial and receipt of investigational drug(s) during 30 days (or 5 half-lives, whichever is longer) prior to randomization.
• Sensitivity, allergy, or contraindication to opioids, alum, or any components of the vaccine
• Prior exposure to opioid vaccines or vaccines containing Keyhole Limpet Hemocyanin.
• Use of prescription psychotropic medications that would potentially interfere with study procedures
• Women of childbearing age who are pregnant, lactating or, not practicing or willing to begin a medically acceptable method of birth control.
• Cannot read or understand the self-report assessment forms unaided or are so severely disabled that they cannot comply with the requirements of the study.
• Medical conditions that may make study participation hazardous:
• History of seizures or cardiac risk conditions (unstable angina, cardiac arrhythmias, chest pain, strong palpitations (subjectively defined as the feeling that the heart is beating too hard, too fast, skipping a beat, or fluttering).
• Elevated liver function tests (i.e., AST and ALT \> 2 times the upper limit of normal).
• Impaired renal function (creatinine \> 1.2).
• Hypertension (\>140/90).
• Asthmatic symptoms within the past 3 years.
• Active hepatitis \[e.g. symptomatic with a positive test for hepatitis B (HBsAg), hepatitis C antibody (HCV), HIV1/HIV2 antibody/antigen\].
• Significant hepatocellular injury as evidenced by elevated bilirubin levels (\>1.3), or elevated levels (over 3x the upper limit of normal) of aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT).
• Creatinine clearance estimated to be less than 60 ml/min.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Clinilabs, Inc.: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Clinilabs Drug Development Corporation

Eatontown, New Jersey, 07724, United States

RECRUITING

New York State Psychiatric Institute: Division on Substance Use Disorders

New York, New York, 10032, United States

ACTIVE NOT RECRUITING

Related Publications (1)

• Damiescu R, Banerjee M, Paul NW, Efferth T. Lessons from COVID-19 to increase opioid vaccine acceptance. Trends Pharmacol Sci. 2022 Dec;43(12):998-1000. doi: 10.1016/j.tips.2022.08.010. Epub 2022 Sep 7.

  PMID: 36123169 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sandra D Comer, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jermaine Jones, PhD

CONTACT

16467746113; jermaine.jones@nyspi.columbia.edu

Sandra Comer, PhD

CONTACT

Sandra.Comer@nyspi.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurobiology (in Psychiatry)

Model Details: Participants are randomized among three arms i.e., to one of three doses of the opioid vaccine: Placebo, Low and High dose. During laboratory sessions, participants will receive intransal doses of placebo versus oxycodone.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 7, 2020
• Study Start: October 8, 2020
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)