An investigational vaccine designed to counter fentanyl’s effects will commence clinical assessments on humans in early 2026. (Image credit: Getty Images)ShareShare by:
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A vaccine that impedes the impacts of fentanyl — encompassing overdose — will proceed to human evaluations in the upcoming months, possibly paving the path for the foremost preemptive therapy for opioid use condition.
The preliminary evaluations will concentrate on gauging the vaccine’s safety, which was initially created with financing from the U.S. Defense Department. The injection was formerly examined in rodents and displayed encouraging outcomes. Presently, it’s been licensed by the nascent company ARMR Sciences, which will commence enlisting individuals for Phase I clinical studies in the Netherlands in 2026, commencing in either January or February.
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How does the vaccine work?
The vaccine functions by preventing fentanyl from entering the brain, achieved through rendering the molecule a focal point of the immune apparatus.
Fentanyl is a fabricated opioid possessing impacts 50 times more potent than heroin. Opioids, likewise termed narcotics, largely operate by affixing to opioid receptors inside the brain and spinal cord, initiating alterations in nerve cell signaling that avert pain and might yield a euphoric state.
Nevertheless, these opioid receptors are also located within the portion of the brain accountable for regulating breathing, thus fentanyl may also diminish respiration to a lethal extent if utilized in excess. A 2-milligram amount of fentanyl — akin in volume to roughly a dozen salt grains — might prove deadly, as per the Drug Enforcement Agency (DEA).
Should an individual overdosing on fentanyl undergo treatment via naloxone (more commonly recognized by the trade name Narcan), with sufficient swiftness, such impacts could be undone. This countermeasure likewise affixes to opioid receptors, consequently obstructing fentanyl’s effects.
ARMR’s vaccine adopts an alternate methodology: It exerts its influence within the circulatory framework, before the substance could access the brain.
“This would constitute the inaugural treatment that does not impact the [opioid] receptor,” Gage communicated to Live Science.
What’s in the vaccine?
To forestall fentanyl from reaching the brain, the immune system must initially discern the drug. However, fentanyl constitutes a minute molecule, not a germ such as a virus, and immune cells do not spontaneously react to its manifestation.
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To provoke an immune reaction to fentanyl, Colin Haile of the University of Houston, an ARMR co-founder and scientific advisor, along with his peers, needed to connect the opioid to something additional.
They opted for a deactivated diphtheria toxin referred to as CRM197, a compound already integrated within vaccines available; once deactivated, the toxin is rendered nontoxic and alternatively aids in stimulating an immune reaction. To amplify this immune reaction even further, they additionally incorporated dmLT, a compound derived from toxins generated by the Escherichia coli bacterium. This adapted compound is not poisonous in itself, and it has additionally undergone human testing in trials involving other, yet-to-be-endorsed, vaccines.
These dual constituents are connected to a synthesized piece of the fentanyl molecule, which independently cannot induce a euphoric sensation or pain alleviation.
Upon the immune apparatus encountering this fusion of fentanyl segments, CRM197, and dmLT, it generates antibodies that react to actual fentanyl. These antibodies connect to the opioid, inhibiting it from traversing the brain’s safeguarding membrane — the blood-brain barrier — and subsequently expelling it from the organism.
Within rodent investigations, the vaccine impeded fentanyl from infiltrating the rodents’ brains and furthermore averted the substance from suppressing respiration and instigating overdose.
How is the vaccine being tested?
Thus far, the vaccine’s evaluations have been conducted on rodents, albeit dmLT and CRM197 have correspondingly undergone some extent of examination and are presently utilized in alternate vaccines for humans. The rat protocol entails administering an initial dosage of the fentanyl vaccine trailed by boosters administered three and six weeks post the initial dosage, Haile conveyed to Live Science.
“The most prolonged duration for which we’ve monitored the animals within our investigations spans approximately six months, and we observed complete obstruction of fentanyl impacts at six months post the primary vaccination,” Haile reported. It persists to be determined how that will translate to “human years,” he observed, yet laboratory rats live approximately a couple of years overall, thus the researchers anticipate the vaccine to function for an extended period within humans.
The initial human assessments slated to commence in early 2026 will enlist 40 participants and will emphasize detecting any safety apprehensions linked to the vaccines, such as undesirable or perilous adverse reactions. Researchers will additionally extract blood samples from participants to ascertain that the vaccine is instigating the formation of anti-fentanyl antibodies.
Should these Phase I assessments prove successful, the subsequent stage will encompass Phase II assessments to evaluate the vaccine’s effectiveness — the degree to which the vaccine impedes fentanyl’s impacts. Within these assessments, antibody concentrations will not only be monitored over time, but selected participants will furthermore be administered secure amounts of fentanyl utilized for pain management in medical procedures. This will be executed under rigorous oversight, to verify the vaccine’s efficacy in the presence of the substance.
The novel vaccine is crafted to thwart fentanyl’s effects, encompassing overdose. Are there potential drawbacks to the vaccine?
Fentanyl possesses valid medical applications as a pain reliever, particularly in critical scenarios. One reservation pertaining to the vaccine entails that individuals who undergo it will forfeit this avenue for pain mitigation.
Nonetheless, the antibodies engendered via inoculation do not affix to alternate opioids — such as morphine, oxycodone, or methadone — or to alternate pain alleviation alternatives, Haile affirmed. That signifies there exist alternatives should individuals who obtain the vaccine necessitate pain relief subsequently.
The medication additionally does not impede buprenorphine, a drug employed to manage opioid utilization disorder by alleviating withdrawal manifestations and yearnings. Haile stated that he and his team are presently assessing the vaccine in conjunction with naltrexone, a non-opioid medication likewise employed to impede the impacts of opioids in substance utilization management.
In principle, it might remain feasible to ingest sufficient fentanyl to override the organism’s reservoir of anti-fentanyl antibodies, Haile conveyed. Nevertheless, considering that the vaccine impedes fentanyl’s euphoric impacts, he anticipates individuals aspiring to cease will not be prompted to endeavor to circumvent it.
“We desire individuals who aspire to cease, aspire to abstain from utilizing the substance,” he expressed. “That will afford them an opportunity to realize that they won’t attain a high from this substance and there exists no utility in ingesting it any longer.”
Who might benefit from the fentanyl vaccine?
Gage proposed that one market for the vaccine might encompass first responders apprehensive regarding unintended fentanyl exposure. (That apprehension has heightened in recent years amid the dissemination of disinformation concerning fentanyl.)
For elucidation: should fentanyl contact your dermis via casual exposure — for example, should you manipulate an object that’s been subjected to the substance — it will not permeate across the skin. Meaningful absorption through the dermis necessitates direct dermis contact with the substance spanning hours or days. That stated, should an EMT or law enforcement officer encounter the substance on their digits and subsequently contact their mouth or eyes, they might sense some of the drug’s analgesic, or pain-relieving, impacts, Haile stated.
The vaccine might additionally constitute “an extra resource within the repository” for individuals grappling with opioid utilization disorder, Gage stated. Consolidating the vaccine with “robust” cognitive behavioral therapy, a form of talk therapy, and communal sustenance might prove “incredibly advantageous to individuals who are simply seeking another lifeline to assist themselves in recuperating,” he remarked.
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Ultimately, the vaccine might prove advantageous for individuals who utilize less-deadly drugs — such as cocaine, stimulants, or painkillers — acquired on the illicit marketplace. That’s attributable to these substances increasingly being cut with fentanyl, implying individuals might overdose without even discerning they are ingesting the opioid.
“I experienced the demise of two intimate childhood companions attributable to fentanyl overdose,” Gage stated. “Neither was deliberately seeking it out.”
Over an estimated 48,000 individuals succumbed to opioid overdoses in 2024 within the U.S., as per provisional statistics. Perhaps stemming from this elevated death toll, preliminary investigation implies that individuals possessing firsthand exposure to opioid utilization disorder and the broader populace alike perceive a prospective anti-fentanyl vaccine favorably. Time will disclose how the novel vaccine executes in human evaluations, but if ultimately endorsed, it might stand as a pioneering instrument against fatality stemming from overdose.
Disclaimer
This article is solely intended for informational purposes and is not designed to furnish medical counsel.
Stephanie PappasSocial Links NavigationLive Science Contributor
Stephanie Pappas functions as a contributing writer for Live Science, encompassing a spectrum of subjects spanning from geoscience to archaeology to the human brain and behavior. She was previously a senior writer for Live Science but is currently a freelancer situated in Denver, Colorado, and routinely contributes to Scientific American and The Monitor, the monthly magazine of the American Psychological Association. Stephanie attained a bachelor’s degree in psychology from the University of South Carolina and a graduate certificate in science communication from the University of California, Santa Cruz.
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