Opioid-use DisorderPhase 1/2NCT04458545
Clinical Trials of Multivalent Opioid Vaccine Components
A Phase 1/2 study testing Oxy(Gly)4-sKLH vaccine - Low Dose and Oxy(Gly)4-sKLH vaccine - High Dose in people with Opioid-use Disorder, run by New York State Psychiatric Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Oxy(Gly)4-sKLH vaccine - Low Dose and Oxy(Gly)4-sKLH vaccine - High Dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2020to 30 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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/testingfactsheet.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.
- Known history of cancer or cancer treatment within 12 months prior to administration of investigational product.
- Receipt of blood products within 3 months of screening.
- Anticipated inability to fulfill all visits and examination procedures throughout the study period (approximately 12 months).
- 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.
- Individuals who currently (within the past 3 months) have a temporary restraining order (TRO) against them or against another person.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sandra Comer, PhD contact
United States2 sites, 1 recruiting
- Recruiting
Clinilabs Drug Development Corporation
Eatontown, New Jersey, 07724
Ronni Spanola, MS, 212-994-4560
- Active, not recruiting
New York State Psychiatric Institute: Division on Substance Use Disorders
New York, New York, 10032
About this study
Official title: Phase 1A/1B Clinical Trials of Multivalent Opioid Vaccine Components
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.
Read the detailed description
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
- Opioid-use Disorder
- Being tested
- Oxy(Gly)4-sKLH vaccine - Low Dose, Oxy(Gly)4-sKLH vaccine - High Dose, Placebo Oxy(Gly)4-sKLH vaccine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxy(Gly)4-sKLH vaccine - Low DoseBiological
Oxy(Gly)4-sKLH vaccine - Low Dose
Oxy(Gly)4-sKLH vaccine - High DoseBiological
Oxy(Gly)4-sKLH vaccine - high dose
Placebo Oxy(Gly)4-sKLH vaccineBiological
Oxy(Gly)4-sKLH vaccine - Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active Vaccine (high dose or low dose) | Experimental | Active Oxy(Gly)4-sKLH vaccine dose (low dose or high dose) Receives: 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 Receives: Biological: Placebo Oxy(Gly)4-sKLH vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability of the opioid vaccine.
Measured: 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.
Measured: 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).
Measured: Throughout the testing session [i.e., pre-dose baseline (Time 0)- Thru- 4.5 hours post-dose].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start8 Oct 2020
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Clinilabs, Inc., National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Sandra D. Comer, New York State Psychiatric Institute
- Investigators
- Sandra D Comer, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458545
- Sponsor's protocol ID
- 7712 ; 00076633
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2020
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36123169
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1A/1B Clinical Trials of Multivalent Opioid Vaccine Components
- ClinicalTrials.gov ID
- NCT04458545
- Acronym / sponsor ID
- 7712 ; 00076633
- Conditions
- Opioid-use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Clinilabs, Inc., National Institute on Drug Abuse (NIDA)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Vaccine (high dose or low dose) | Experimental | Biological: Oxy(Gly)4-sKLH vaccine - Low Dose, Biological: Oxy(Gly)4-sKLH vaccine - High DoseActive Oxy(Gly)4-sKLH vaccine dose (low dose or high dose) |
| Placebo Oxy(Gly)4-sKLH vaccine dose | Placebo comparator | Biological: Placebo Oxy(Gly)4-sKLH vaccinePlacebo Oxy(Gly)4-sKLH vaccine |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxy(Gly)4-sKLH vaccine - Low DoseOxy(Gly)4-sKLH vaccine - Low Dose | Biological | Active Vaccine (high dose or low dose) |
| Oxy(Gly)4-sKLH vaccine - High DoseOxy(Gly)4-sKLH vaccine - high dose | Biological | Active Vaccine (high dose or low dose) |
| Placebo Oxy(Gly)4-sKLH vaccineOxy(Gly)4-sKLH vaccine - Placebo | Biological | Placebo Oxy(Gly)4-sKLH vaccine dose |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Beginning from first vaccination through study completion (43 Weeks).
Safety and tolerability of the opioid vaccine.
Immune response to Oxy(Gly)4-sklh
Time frame: Baseline, Weeks 0-8, Weeks 10, 12, 14, 18, 19, 20, 23, 34, 42
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.
Effects of Vaccine on Intranasal Drug Positive Subjective Effects
Time frame: Throughout the testing session [i.e., pre-dose baseline (Time 0)- Thru- 4.5 hours post-dose].
Peak self-reported drug "Liking." Measured using a visual analog scale (0-100).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Derived from this study: PubMed 36123169Damiescu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra Comer, PhD contact
Sandra D Comer, PhD principal investigator
New York State Psychiatric Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oxy(Gly)4-sKLH vaccine - Low Dose and Oxy(Gly)4-sKLH vaccine - High Dose in people with Opioid-use Disorder, run by New York State Psychiatric Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jermaine Jones, PhD (16467746113, jermaine.jones@nyspi.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Beginning from first vaccination through study completion (43 Weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04458545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.