Clinical Trial Evaluating Vaccine Against Opioid Use Disorders Enrolls First Patients

A phase 1, randomized, placebo-controlled clinical trial designed to study a therapeutic vaccine for opioid use disorder has enrolled its first patients, according to a press release from the University of Minnesota Medical School. Funded by a grant from the National Institutes of Health, this trial is intended to test the safety and efficacy of a vaccine designed to selectively prevent the euphoric and toxic effects of oxycodone.

The study is seeking volunteers between 18 and 59 years of age who are currently using opioids and not seeking treatment for drug use and have prior experience with intranasal opioid use. Participants are being enrolled at Columbia University in New York City and Clinilabs Drug Development Corporation in Eatontown, New Jersey, with the goal of enrolling up to 45 volunteers.

Study participants will be closely monitored for several weeks on inpatient units at Columbia University Irving Medical Center and at Clinilabs. The investigators will be following these patients to look for adverse events and determine their response to oxycodone after vaccination before shifting the study to examine their drug behavior on an outpatient basis.

“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 Marco Pravetoni, PhD, an associate professor of pharmacology and medicine at the University of Minnesota Medical School, in a press release.

The vaccine being studied stimulates the body’s immune system to produce antibodies against oxycodone. In a vaccinated individual who takes oxycodone, those antibodies bind to the drug molecule and prevent it from entering the brain, which in turn would prevent the high produced by the drug, according to the researchers. Further, the vaccine’s selectivity disallows it from interfering with FDA-approved medications, such as methadone, buprenorphine, naltrexone, and naloxone.

“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,” said Sandra Comer, PhD, director of the Opioid Laboratory in the Division on Substance Use Disorders in the Department of Psychiatry at Columbia University Vagelos College of Physicians and Surgeons, in the release. “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.”

REFERENCE

First-in-human clinical trial for a vaccine to treat opioid use disorders enrolls first patients [news release]. EurekAlert; September 7, 2021. Accessed September 15, 2021. https://www.eurekalert.org/news-releases/927548