Clinical Trials of Multivalent Opioid Vaccine Components

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Opioid-use Disorder

In brief

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.

Key facts

Study ID: NCT04458545
Run by: New York State Psychiatric Institute
People needed: 45
Starts: 2020-10-08
Expected to finish: 2027-03-30
Last updated by the study team: 2026-04-23

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

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.
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.
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)
Current chronic pain (persistent for longer than 3 months).
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.
Previous serious or unexpected adverse reaction to a vaccine, including GuillainBarré syndrome.
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.
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.

Where it is running

Clinilabs Drug Development Corporation — Eatontown, New Jersey, United States (enrolling)
New York State Psychiatric Institute: Division on Substance Use Disorders — New York, New York, United States

Full record on ClinicalTrials.gov

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