Opioid Vaccine for Opioid Use Disorder

Recruiting at 1 trial location

Overseen By Sandra Comer, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: New York State Psychiatric Institute

Must not be taking: Psychotropics, Inhaled corticosteroids

Disqualifiers: Seizures, Cardiac conditions, Hypertension, others

Compensation: Varies

Number of Visits: 13

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine, Oxy(Gly)4-sKLH or the Oxycodone Vaccine, to treat Opioid Use Disorder (OUD) by blocking oxycodone, a commonly abused opioid, from reaching the brain. Researchers aim to determine if this vaccine can reduce the appeal of opioids and help prevent relapses. The study assesses the vaccine's safety and its ability to trigger the body to produce antibodies that counteract opioid effects. Suitable participants include those with a history of daily heroin or fentanyl use who are not currently seeking treatment for drug use. As a Phase 1, Phase 2 trial, this study focuses on understanding the vaccine's effects in people and measuring its effectiveness in a smaller group, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires that participants are not on medication-assisted treatment for Opioid Use Disorder, such as buprenorphine, methadone, or naltrexone. Additionally, participants cannot use certain medications like inhaled corticosteroids or immunosuppressive agents within 30 days before the study product is given.

Is there any evidence suggesting that the Oxy(Gly)4-sKLH vaccine is likely to be safe for humans?

Research has shown that the Oxy(Gly)4-sKLH vaccine, developed to aid opioid addiction, has been safe in animal studies. For instance, rats that received high doses of the vaccine experienced no harmful effects, indicating safety for further human testing.

Earlier studies also found that the vaccine is effective at low doses without causing negative effects. Although more human research is necessary, these results are encouraging for the vaccine's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Oxy(Gly)4-sKLH vaccine because it offers a novel approach to treating opioid use disorder. Unlike current treatments, which typically involve medications like methadone or buprenorphine that manage cravings and withdrawal symptoms, this vaccine aims to trigger the immune system to produce antibodies that block opioids from reaching the brain. This means it could potentially prevent the high associated with opioid use, reducing the risk of relapse. Additionally, the vaccine approach might provide longer-lasting protection with fewer daily dosing requirements, offering a groundbreaking alternative in the fight against addiction.

What evidence suggests that the Oxy(Gly)4-sKLH vaccine might be an effective treatment for opioid use disorder?

Research has shown that the Oxy(Gly)4-sKLH vaccine helps the body produce antibodies targeting oxycodone, a common opioid. These antibodies bind to the drug in the blood, preventing it from reaching the brain. Animal studies have demonstrated that the vaccine generates strong and long-lasting antibodies, potentially reducing the pleasurable effects of opioids. The vaccine has also proven safe in animal tests, even at high doses, with no harmful effects. In this trial, participants will receive either a high or low dose of the active Oxy(Gly)4-sKLH vaccine or a placebo. Although human studies provide limited information, these findings are promising for reducing opioid abuse. ^{1 2 3 5 6}

Who Is on the Research Team?

Sandra D Comer, PhD

Principal Investigator

New York State Psychiatric Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-59 with moderate to severe opioid use disorder who are not seeking treatment and prefer drugs other than certain prescription opioids. They must be able to follow the study plan, weigh less than 300 pounds, have no major health issues like kidney problems or high blood pressure, and women must use birth control if of childbearing potential.

Inclusion Criteria

I weigh less than 300 pounds and my waist is less than 52 inches.

Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Willing and able to comply with scheduled visits, dosing plan, laboratory tests, and other study procedures

Exclusion Criteria

I am allergic to opioids, alum, or vaccine ingredients.

I have not had cancer or cancer treatment in the last year.

I am not allergic to lactose.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Outpatient Study Visit

Participants receive the Oxy(Gly)4-sKLH vaccine or placebo at Weeks 0, 3, 6, and 18

21 weeks

4 visits (in-person)

Laboratory Session

Participants undergo laboratory assessments to evaluate immune response and drug effects

1 week

3 visits (in-person)

Extended Follow-up

Participants are monitored for safety and effectiveness after treatment

21 weeks

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Oxy(Gly)4-sKLH

Trial Overview The trial tests a vaccine aimed at treating opioid addiction by generating antibodies against oxycodone. It will assess safety, antibody production, and effectiveness in reducing drug liking after opioid administration. Participants will receive different doses of the vaccine or placebo across two sites.

How Is the Trial Designed?

Group I: Active Vaccine (high dose or low dose) Experimental Treatment 2 Interventions

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

Group II: Placebo Oxy(Gly)4-sKLH vaccine dose Placebo Group 1 Intervention

Placebo Oxy(Gly)4-sKLH vaccine

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Clinilabs, Inc.

Collaborator

Trials

9

Recruited

650+

Published Research Related to This Trial

The study developed an opioid conjugate vaccine using OXY(Gly)(4) that produced high levels of antibodies specifically targeting oxycodone and its metabolite, oxymorphone, while showing minimal cross-reactivity with other opioids, indicating a focused immune response.

Immunization with the OXY(Gly)(4)-KLH vaccine significantly altered the pharmacokinetics of oxycodone in rats, reducing its free concentration in plasma and brain distribution, which suggests potential for this vaccine to mitigate the effects of oxycodone abuse and addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An oxycodone conjugate vaccine elicits drug-specific antibodies that reduce oxycodone distribution to brain and hot-plate analgesia. Pravetoni, M., Le Naour, M., Harmon, TM., et al.[2021]

The heroin vaccine (M-KLH) effectively increased the retention of heroin and its metabolites in the bloodstream while reducing their distribution to the brain, particularly at lower doses, and also protected against respiratory depression.

The oxycodone vaccine (OXY-KLH) significantly reduced the brain distribution of oxycodone, especially when administered subcutaneously, indicating that the effectiveness of these vaccines varies based on the dose and method of drug administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Dose- and Route-Dependent Efficacy of Oxycodone and Heroin Vaccines in Rats. Raleigh, MD., Laudenbach, M., Baruffaldi, F., et al.[2019]

The OXY-dKLH vaccine effectively protects against the toxic effects of oxycodone, as evidenced by a rightward shift in dose-response curves for pain relief and respiratory depression in vaccinated rats, indicating reduced sensitivity to oxycodone's harmful effects.

Importantly, the vaccine does not interfere with the effectiveness of naloxone, an opioid antagonist used for overdose reversal, and maintains immunogenicity even when administered alongside opioids like morphine, suggesting it could be a safe option for treating oxycodone abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of an oxycodone vaccine: Addressing some of the unique considerations posed by opioid abuse. Raleigh, MD., Peterson, SJ., Laudenbach, M., et al.[2020]

The Oxy(Gly)4-sKLH vaccine shows promise as a therapeutic option for opioid use disorders, demonstrating sustained antibody responses for up to five months without boosting antibody levels in response to oxycodone exposure, which minimizes concerns about immune-related side effects.

This vaccine effectively reduces the reinforcing effects of oxycodone while preserving the efficacy of other opioid medications like naloxone and methadone, indicating its potential for safe integration into existing treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological mechanisms underlying the efficacy of antibodies generated by a vaccine to treat oxycodone use disorder. Raleigh, MD., King, SJ., Baruffaldi, F., et al.[2022]

The Oxy(Gly)4-sKLH Conjugate Vaccine demonstrated strong immunogenicity, producing high antibody levels in Sprague Dawley rats even at low doses, indicating its potential effectiveness in treating opioid use disorders.

Safety assessments showed no significant toxicological effects related to the vaccine, suggesting it is well tolerated and does not cause harmful side effects, which is crucial for its future clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-clinical safety and toxicology profile of a candidate vaccine to treat oxycodone use disorder. Hamid, FA., Marker, CL., Raleigh, MD., et al.[2023]

The study identified an effective opioid conjugate vaccine using an oxycodone-based hapten that significantly reduced the distribution of oxycodone to the brain in mice, demonstrating its potential as a treatment for opioid use disorders.

Both heroin vaccines formulated with different carrier proteins (EcoCRM and KLH) were equally effective in reducing the effects of heroin and its metabolites, suggesting promising candidates for further development in preventing opioid overdoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Efficacy and Characterization of Candidate Vaccines for Treatment of Opioid Use Disorders Using Clinically Viable Carrier Proteins. Baruffaldi, F., Kelcher, AH., Laudenbach, M., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0028390821002082

Pharmacological mechanisms underlying the efficacy of ... These rodent studies confirm that active immunization with Oxy(Gly) 4 -sKLH induces highly specific and long-lasting antibodies which are effective in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9186020/

Pre-clinical safety and toxicology profile of a candidate ... Results showed that the intramuscular administration of the Oxy(Gly)4-sKLH vaccine was tolerable even at high doses with no evidence of adverse effects in rats.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04458545

Clinical Trials of Multivalent Opioid Vaccine Components 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.

4. withpower.com withpower.com/trial/phase-2-opioid-related-disorders-4-2021-3dfa8

Opioid Vaccine for Opioid Use Disorder 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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X22003644

Pre-clinical safety and toxicology profile of a candidate ... Results showed that the intramuscular administration of the Oxy(Gly)4-sKLH vaccine was tolerable even at high doses with no evidence of adverse ...

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0184876

Safety and efficacy of an oxycodone vaccine These data argue against the possibility that chronic or ongoing opioid use would impair oxycodone vaccine immunogenicity.