A vaccine to prevent the deadly effects of fentanyl is moving toward human clinical trials.
The vaccine, which has shown positive results in mouse and rat studies, is designed to block fentanyl from entering the brain, blocking its effects and preventing overdose.
If approved, it would be the first treatment for prevention. Fentanyl overdoseAccording to statistics, this is the main cause of drug overdose deaths. This is different from treatments like naloxone, which reverse the effects after an overdose.
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vaccine It is designed to generate antibodies against fentanyl, which prevents the drug from crossing the blood-brain barrier. It contains a synthetic fragment of fentanyl bound to a protein called CRM197 and the immune-stimulating compound dmlT.
This combination stimulates the immune system to produce antibodies before it can capture fentanyl in the bloodstream. reach the brainsaid Colin Hale of the University of Houston, co-founder and scientific advisor to ARMR Science, which authorized the vaccine.
“There are anti-fentanyl antibodies present in the blood of people who have been vaccinated,” Hale told Fox News Digital. “So when they take fentanyl, their antibodies grab the drug and prevent it from entering the brain. They take fentanyl and don’t feel any effects. No effects at all. And they don’t overdose.”
Eventually, he said, fentanyl will be eliminated from the body.
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In studies of mice and rats, the animals still had antibodies to fentanyl six months after vaccination, added Heil, a research associate professor of psychology at the university and a founding member of the university’s Institute for Drug Discovery.
Some question whether such vaccines indirectly promote infection; drug useHeil noted that the drug “doesn’t have a euphoric effect” on vaccinated people, so those seeking a “high” won’t get it.
The main benefit, Heil said, is that the vaccine reduces the potential health risks of fentanyl.
”respiratory depression “This is the main effect of inducing death with this highly potent synthetic opioid,” he said.
Following successful trials in mice and rats, first human clinical trials are scheduled to begin in early 2026 at the Human Drug Research Center affiliated with Leiden University in the Netherlands.
This small Phase 1 trial will enroll approximately 40 participants, with a focus on safety and security. immune response.
After Phase 1 safety trials, Phase 2 trials will test whether the vaccine effectively blocks the effects of fentanyl in humans.
The main limitation is that data so far is only available in mouse models, and it is unclear how effective the vaccine will be in humans.
Heil told FOX News Digital there were no negative effects. side effects Animal studies have been reported, likely because the vaccine components are proteins already used in other combinations in humans, so their safety profile is already known.
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“Also, unlike other vaccines, we use extremely low doses of ingredients,” he noted. “We have administered the vaccine to many animals and have not seen any adverse side effects.”
Haile said toxicology studies in which researchers administered doses 20 times higher than those given to humans showed no obvious signs of toxicity.
Mr. Heil mentioned several different use cases for vaccines, primarily the following: opioid use disorder People who want to stop using fentanyl. It could also be used by first responders and health care workers who want to reduce the risk of accidental exposure.
Haile said military and national security personnel could also benefit from the vaccine, as it could help protect against fentanyl and fentanyl-like compounds, which are used as chemical threats.
Finally, parents may seek protection such as: teens at risk or young people, as fentanyl is known to be mixed with other substances such as marijuana.
Looking ahead, Haile said this could pave the way for the approval of other anti-drug vaccines, such as those already in development, such as cocaine and methamphetamine.
“Tackling major problems like fentanyl, cocaine and methamphetamine will save hundreds of thousands of lives,” he added.
FOX News senior medical analyst Dr. Mark Siegel said vaccine progress is “very exciting progress with significant upside.”
“We are very pleased that this drug is now in human clinical trials. very well studied“This will likely sedate the patient and prevent many of the overdoses where fentanyl causes them to stop breathing,” he told Fox News Digital.
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Siegel noted that antidotes for fentanyl (Narcan) are limited by the long-lasting effects of fentanyl, but Narcan (an opioid antagonist) wears off in just a few hours and must be re-administered.
“We want to make sure this vaccine is really limited to people who are at risk from opioids. Overdose and addictionThis is because fentanyl is also useful as a painkiller for cancer and is also useful in anesthesia,” the doctor added.
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The vaccine was developed with funding from the US Department of Defense and licensed to biotech startup ARMR Sciences.
