Clinical Trials of Multivalent Opioid Vaccine Components
NCT ID: NCT04458545
Last Updated: 2025-05-13
Study Results
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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RECRUITING
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2020-10-08
2026-03-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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)
Oxy(Gly)4-sKLH vaccine - Low Dose
Oxy(Gly)4-sKLH vaccine - Low Dose
Oxy(Gly)4-sKLH vaccine - High Dose
Oxy(Gly)4-sKLH vaccine - high dose
Placebo Oxy(Gly)4-sKLH vaccine dose
Placebo Oxy(Gly)4-sKLH vaccine
Placebo Oxy(Gly)4-sKLH vaccine
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
Oxy(Gly)4-sKLH vaccine - High Dose
Oxy(Gly)4-sKLH vaccine - high dose
Placebo Oxy(Gly)4-sKLH vaccine
Oxy(Gly)4-sKLH vaccine - Placebo
Eligibility Criteria
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Exclusion Criteria
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.
18 Years
59 Years
ALL
Yes
Sponsors
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Clinilabs, Inc.
OTHER
National Institute on Drug Abuse (NIDA)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Sandra D. Comer
Professor of Neurobiology (in Psychiatry)
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
New York State Psychiatric Institute: Division on Substance Use Disorders
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Ronni Spanola, MS
Role: primary
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.
Other Identifiers
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7712 ; 00076633
Identifier Type: -
Identifier Source: org_study_id
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