Clinical Trials of Multivalent Opioid Vaccine Components

NCT ID: NCT04458545

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2026-03-30

Brief Summary

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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

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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

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Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active Vaccine (high dose or low dose)

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

Group Type EXPERIMENTAL

Oxy(Gly)4-sKLH vaccine - Low Dose

Intervention Type BIOLOGICAL

Oxy(Gly)4-sKLH vaccine - Low Dose

Oxy(Gly)4-sKLH vaccine - High Dose

Intervention Type BIOLOGICAL

Oxy(Gly)4-sKLH vaccine - high dose

Placebo Oxy(Gly)4-sKLH vaccine dose

Placebo Oxy(Gly)4-sKLH vaccine

Group Type PLACEBO_COMPARATOR

Placebo Oxy(Gly)4-sKLH vaccine

Intervention Type BIOLOGICAL

Oxy(Gly)4-sKLH vaccine - Placebo

Interventions

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Oxy(Gly)4-sKLH vaccine - Low Dose

Oxy(Gly)4-sKLH vaccine - Low Dose

Intervention Type BIOLOGICAL

Oxy(Gly)4-sKLH vaccine - High Dose

Oxy(Gly)4-sKLH vaccine - high dose

Intervention Type BIOLOGICAL

Placebo Oxy(Gly)4-sKLH vaccine

Oxy(Gly)4-sKLH vaccine - Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Exclusion Criteria

1. Participation in a clinical trial and receipt of investigational drug(s) during 30 days (or 5 half-lives, whichever is longer) prior to randomization.
2. Sensitivity, allergy, or contraindication to opioids, alum, or any components of the vaccine
3. Prior exposure to opioid vaccines or vaccines containing Keyhole Limpet Hemocyanin.
4. Use of prescription psychotropic medications that would potentially interfere with study procedures
5. Women of childbearing age who are pregnant, lactating or, not practicing or willing to begin a medically acceptable method of birth control.
6. 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.
7. 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.
* Current gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition.
* Sleep apnea as assessed by the STOP-Bang questionnaire; those with high risk will be excluded from the study
* Hemoglobin: Women \<11.5; men \<13.
8. Newly diagnosed HIV infection or known HIV infection with CD4 counts below normal levels, active tuberculosis, or other immunocompromising diseases.

For HIV testing, we follow guidelines from the New York State Department of Health (https://www.health.ny.gov/diseases/aids/providers/testing/docs/testing\_fact\_sheet.pdf)
9. Current chronic pain (persistent for longer than 3 months).
10. Current or history of psychotic disorder or other severe Axis I disorder based on DSM 5 criteria, other than OUD, including physical dependence on drugs that pose risk of withdrawal that requires medical management such as alcohol or benzodiazepines. Participants diagnosed with dysthymia or mild-moderate depression with no recent suicidal ideation may be included. Recent suicidal ideation" is defined as thoughts about suicide within the past month.
11. Previous serious or unexpected adverse reaction to a vaccine, including GuillainBarré syndrome.
12. Use of inhaled corticosteroids, immunosuppressive agents or other medications within 30 days prior to administration of investigational product that might interfere with an immune response. Antihistamines may not be used within 7 days prior to administration of investigational product.
13. Use of any vaccine, with the exception of influenza vaccine, or COVID-19 vaccine 30 days prior to administration of study product. Participants who have received the Moderna or Pfizer COVID-19 vaccine will not be eligible to receive study product until 30 days after they have received the second vaccine dose; participants who have received the Johnson and Johnson COVID-19 vaccine will not be eligible to receive study product until 30 days after they have received the vaccine dose.
14. Known history of cancer or cancer treatment within 12 months prior to administration of investigational product.
15. Receipt of blood products within 3 months of screening.
16. Anticipated inability to fulfill all visits and examination procedures throughout the study period (approximately 12 months).
17. Individuals who are on medication-assisted treatment for Opioid Use Disorder (e.g., buprenorphine, buprenorphine/naloxone, methadone, naltrexone). We will also exclude participants from our study who "doctor shop" by reviewing information obtained from PMPs.
18. Individuals who currently (within the past 3 months) have a temporary restraining order (TRO) against them or against another person.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinilabs, Inc.

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Sandra D. Comer

Professor of Neurobiology (in Psychiatry)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra D Comer, PhD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

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Clinilabs Drug Development Corporation

Eatontown, New Jersey, United States

Site Status RECRUITING

New York State Psychiatric Institute: Division on Substance Use Disorders

New York, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Jermaine Jones, PhD

Role: CONTACT

16467746113

Sandra Comer, PhD

Role: CONTACT

Facility Contacts

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Ronni Spanola, MS

Role: primary

212-994-4560

References

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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.

Reference Type DERIVED
PMID: 36123169 (View on PubMed)

Other Identifiers

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7712 ; 00076633

Identifier Type: -

Identifier Source: org_study_id

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