Marco Pravetoni

The University of Minnesota Medical School has developed a therapeutic vaccine for opioid use disorder that is the subject of a new Phase 1 randomized placebo-controlled clinical trial.

The trial, which recently begun enrollment, will be conducted at the Columbia University Irving Medical Center in New York. Sandra Comer, a professor of neurobiology at the College of Physicians and Surgeons of Columbia University, will lead the research.

Researchers at the University of Minnesota developed the vaccine candidate to selectively inhibit the euphoric and toxic effects of oxycodone, the semi-synthetic opioid drug. The vaccine stimulates the production of antibodies to oxycodone, which eventually halt its entry to the brain.

Oxycodone brands include Oxycontin, Xtampza ER, Oxaydo and Roxicodone.

In the long run, the researchers aim to develop a range of opioid vaccines for commonly abused drugs such as heroin and fentanyl, and fentanyl analogs, such as carfentanil. Their work is currently focused on initial Phase I clinical testing with the ultimate goal of advancing these novel medications to FDA approval.

The National Institute on Drug Abuse of the National Institutes of Health is offering financial support for the Phase 1 trial.

A researcher holds a vial of an investigational opioid vaccine.

Marco Pravetoni, an associate professor of pharmacology and medicine at the University of Minnesota, is leading the drug discovery research. Pravetoni has also worked to develop a number of vaccines and monoclonal antibodies to treat respiratory depression and bradycardia from oxycodone, fentanyl and heroin. His research is featured in the Journal of Pharmacology and Experimental Therapeutics and the Journal of Medicinal Chemistry.

When Pravetoni asked about his inspiration for the research, he pointed to the goal to develop “more treatment options for opioid use disorders and overdose.” Opioid vaccines “will have a beneficial impact on patients, their families and society on many levels,” Pravetoni said.

“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,” Pravetoni said.

“Inspired by the development of COVID-19 vaccines, we hope that translation of opioid vaccines will have a positive public health impact by preventing future epidemics,” Pravetoni said.