Initial clinical trials with an opioid use disorder vaccine are underway

A vaccine to treat substance abuse? Inoculations are commonly used to prevent infectious diseases such as COVID-19, but they may also have the potential to treat drug disorders.

A team of researchers from the University of Minnesota and Columbia University are studying an oxycodone vaccine that they hope can be used to treat opioid use disorders. They have launched the first clinical trial to test such a vaccine on humans.

Current treatment methods include a combination of medication and counseling and behavioral therapies. A vaccine may not only help treat addiction, but it may also prevent it from happening in the first place, advocates say.

“We have good drugs for the treatment of opioid disorder, but about half of the people who use these drugs fall back after about six months,” said Sandra Comer, professor of neurobiology at Columbia University and lead researcher in the experiment.

“A vaccine that lasts for several months, given in combination with any of these drugs, can help many more people beat their addiction and potentially protect them from an overdose death if a patient returns.”

Although there are no federally approved vaccines for opioid disorder, it is not a completely new concept. A similar vaccine that prevents opioids from reaching the brain is also being developed by Virginia Tech researchers.

This vaccine was developed by Marco Pravetoni, a researcher at the University of Minnesota, who has helped conduct preclinical studies of a number of vaccines designed to counteract side effects caused by oxycodone, fentanyl and heroin. These side effects include depressed breathing and depressed heart rate.

The Oxycodone vaccine specifically stimulates the immune system’s production of antibodies that prevent the drug from entering the brain and creating the high users who want it.

Because it is only targeted at oxycodone, researchers say the vaccine will not interfere with drugs approved by the Food and Drug Administration, such as methadone, buprenorphone, naltrexone and naloxone.

In preclinical studies, animals receiving the vaccine administered less oxycodone and were protected against toxicity and signs of overdose, including respiratory depression.

“In this study, my laboratory will perform pharmacokinetic and immunological monitoring in blood samples from immunized volunteers to ensure that they form antibodies to oxycodone and determine whether the antibodies prevent the drug from reaching the brain,” Pravetoni said.

Columbia University researchers will closely monitor study participants for adverse reactions to the vaccine and changes in their response to oxycodone after vaccination. The Phase 1 program plans to enroll up to 45 participants. Volunteers are still being enrolled at Columbia University in New York City and Clinilabs Drug Development Corporation in Eatontown, New Jersey.

“This medication method is unique in that it can be used alone or in combination with other treatment medications and most importantly can offer patients long-term protection against overdose if they return to opioid use,” Comer said.

“The long-term goal of this program is to develop a range of opioid vaccines targeted at other commonly used opioids, such as heroin and fentanyl. We are very excited about this research and hope to eventually be able to offer a safe, new treatment option for patients with opioid use disorders. “

If the vaccine proves to be safe and effective in preventing the euphoric and toxic effects of oxycodone, researchers hope it could be another important tool against the current opioid epidemic.

Nearly 50,000 Americans died of opioid-related overdoses in 2019 and new data from American Centers for Disease Control and Prevention shows that drug overdose deaths rose to 87,000 in 2020 during the pandemic, with a large percentage of overdose deaths related to fentanyl and other synthetic opioids.

Because each type of opioid has its own unique chemical structure, a different vaccine will be needed for each opioid, researchers say. The teams at Columbia and the University of Minnesota are working to develop similar vaccines against heroin and fentanyl.

Health officials says these vaccines may be useful for people at risk, patients in drug recovery programs, and first-aiders who may be inadvertently exposed to an opioid.


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