Experimental Opioid Vaccine Being Studied at Columbia

Researchers at Columbia University’s Vagelos College of Physicians and Surgeons are now conducting a Phase 1a/1b clinical trial for the first vaccine to be tested in the US for opioid use disorder.

The vaccine is designed to create antibodies that prevent oxycodone from reaching the brain, where oxycodone generates a euphoric feeling for users, but also can impair the brain’s breathing centers. The vaccine targets oxycodone exclusively, so it does not interfere with other opioid-based medications used for treating opioid use disorder or naloxone.

“We have good medications to treat opioid use disorder, but about half of the people who use these medications relapse after about 6 months,” Sandra Comer, PhD, a professor of neurobiology in the Department of Psychiatry at Columbia’s College of Physicians and Surgeons and principal investigator of the trial, said in a news release. “A vaccine that lasts for several months, given in combination with any of these medications, could help many more people beat their addiction and potentially protect them from an overdose death if a patient relapses.”

For the 1a/1b trial, researchers now enrolling up to 24 volunteers to participate in the study who are opioid users but not receiving MAT for OUD. Participants will be divided into 3 groups: a group that receives a placebo, one that receives a low dose of active vaccine, and one that receives a high dose. Researchers from the University of Minnesota, meanwhile, will monitor blood samples from the study participants to explore how the vaccine works and potentially identify biomarkers that can predict its efficacy. If the vaccine proves safe and shows potential efficacy, the trial will expand to up to 45 patients before moving into phases 2 and 3.

The researchers noted in the release that because different opioids have different chemical structures, different vaccines will be needed for each drug. In addition to their work on the oxycodone vaccine, the Columbia and Minnesota researchers are developing similar vaccines against heroin and fentanyl. The latter could be especially useful for protecting first responders and law enforcement who inadvertently inhale carfentanil.