First Participant Enrolled in Trial for Vaccine to Treat Opioid Disorders

A clinical trial studying a vaccine for opioid use disorder developed by University of Minnesota Medical School researchers has enrolled its first participants. The phase 1 randomized placebo-controlled trial, funded by a grant from the National Institutes of Health, will test the safety and potential efficacy of a vaccine that could prevent both the euphoric and toxic effects of oxycodone.

“This medication approach is unique in that it can be used alone or in combination with other treatment medications and, importantly, may offer patients long-lasting protection against overdose if they relapse to opioid use. The long-term goal of this program is to develop a series of opioid vaccines that target other commonly used opioids, such as heroin and fentanyl.

We are very excited about this research and hope to eventually provide a safe, new treatment option for patients with opioid use disorder,” said principal investigator Sandra Comer, PhD, director of the Opioid Laboratory in the Department of Psychiatry at Columbia University Vagelos College of Physicians and Surgeons.

Comer will oversee a medical team led by Jeanne Manubay, MD, the study's medical director. Manubay will monitor the patients’ response to the vaccine, including their subsequent drug use and behaviors.

Trial participants are being enrolled at Columbia University in New York City and Clinilabs Drug Development Corporation, in Eatontown, New Jersey. Participants must be between the ages of 18 and 59, must be currently using opioids and not seeking treatment for drug use, and must have prior experience with intranasal opioid use.

Marco Pravetoni, PhD’s laboratory led the development of the series of vaccines and monoclonal antibodies that counteract depressed breathing and depressed heart rate induced by oxycodone, fentanyl, and heroin in preclinical studies.

The vaccine under observation stimulates the body’s immune system to produce antibodies to oxycodone. When a vaccinated individual takes oxycodone, the antibodies bind to the drug molecule and stop it from entering the brain, ultimately preventing the high the drug produces. As the vaccine selectively targets oxycodone, it will not interfere with US Food and Drug Administration approved medications, like methadone, buprenorphine, naltrexone, or naloxone.

“In this study, my laboratory will conduct pharmacokinetic and immunological monitoring in blood samples from immunized volunteers to ensure that they are making antibodies to oxycodone and determine whether or not the antibodies are preventing the drug from reaching the brain,” said Pravetoni.

The study plans to enroll up to 45 participants, who will be closely monitored for several weeks in inpatient units at Columbia University Irving Medical Center and at Clinilabs. Researchers will look for adverse events, determine participants’ response to oxycodone after vaccination, and then study their drug behavior on an outpatient basis.

“Clinilabs is privileged to be working with the University of Minnesota Medical School and Columbia University on this groundbreaking trial. Exploring a preventative vaccine to treat opioid use disorder has the potential to be life-altering for patients and their families who are battling opioid abuse,” said Gary Zammit, Clinilabs’ President and CEO.

For more on vaccines, see Anti-Fentanyl Vaccines as Medical Solutions to Overdose Deaths.

This article originally appeared on Psychiatric Times.

Reference

1. First-in-human clinical trial for a vaccine to treat opioid use disorders enrolls first patients. World Pharma News. September 7, 2021. Accessed September 14, 2021. https://www.worldpharmanews.com/index.php?option=com_content&view=article&id=5792:first-in-human-clinical-trial-for-a-vaccine-to-treat-opioid-use-disorders-enrolls-first-patients&catid=13:research