Texas-based researchers have developed a vaccine that blocks the euphoric effects of fentanyl, a potent synthetic opioid that is increasingly involved in opioid overdose deaths in the United States.
In studies in male and female mice, the vaccine generated significant and long-lasting levels of anti-fentanyl antibodies that were highly effective at reducing the antinociceptive, behavioral, and physiological effects of the drug.
“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Dr. Haile.
The vaccine did not cause any adverse effects in the immunized mice. The research team plans to start manufacturing clinical-grade vaccine in the coming months with clinical trials in humans planned soon.
If proven safe and effective in clinical testing, the vaccine could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids, the researchers note.
The United States in 2021 recorded more than 107,000 drug overdose deaths – a record high, according to federal health officials – and fentanyl was involved in most of these deaths.
Senior author Therese Kosten, PhD, director of the UH Developmental, Cognitive & Behavioral Neuroscience program, calls the new fentanyl vaccine a potential “game changer.”
“Fentanyl use and overdose is a particular treatment challenge that is not adequately addressed with current medications because of its pharmacodynamics, and managing acute overdose with the short-acting naloxone [Narcan] is not appropriately effective as multiple doses of naloxone are often needed to reverse fentanyl’s fatal effects,” said Dr. Kosten.
Funding for the study was provided by the Department of Defense through the Alcohol and Substance Abuse Disorders Program managed by RTI International’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has funded Dr. Haile’s lab for several years to develop the anti-fentanyl vaccine. The authors have no relevant conflicts of interest. A provisional patent has been submitted by the University of Houston on behalf of four of the investigators containing technology related to the fentanyl vaccine.
A version of this article first appeared on.