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Groundbreaking vaccine for FENTANYL that stops users from getting 'high' heads for human trials
A new vaccine that may totally block the effects of fentanyl is set to enter human clinical trials.
The shot, which has shown promise in animal studies, primes the immune system to recognize and attack the highly addictive opioid before it reaches the brain.
This prevents the drug from binding to receptors responsible for pain relief and euphoria. It would also avoid an overdose, which happens when the drug binds to receptors and interferes with breathing.
Researchers from Houston University who developed the vaccine aim to launch human trials in April 2025.
They hope the groundbreaking treatment could help curb the fentanyl epidemic that is killing more than 103,000 Americans every year.
Researchers developed a three-shot vaccine that leads to the formation of fentanyl antibodies in a person's bloodstream. These antibodies can prevent the drug from reaching the brain and totally negate it. This, in turn, stops overdoses
A sad scene persists on Kensington Ave in Philadelphia at Christmas last year. Fentanyl has run riot in the US drug supply, leading to a surge in drug overdose deaths
If successful, the vaccine will then move to further trials — but researchers say it could still be five to ten years before it reaches hospitals.
A total of 103,451 people are estimated to be dying from drug overdoses in the US every year, estimates suggest — with 70 percent of these fatalities thought to have been caused by fentanyl.
The drug is fatal in small doses — as little as three milligrams — and is 50 times stronger than heroin and 100 times stronger than morphine.
Dr Colin Haile, a research associate professor at the University of Houston leading the shot's development, said the team was working quickly to get the vaccine tested and out to hospitals.
'We need to get something to market as quickly as possible to address this terrible problem,' he said. 'The ultimate goal is to protect people and save lives.'
Doctors are already using naloxone — brand name Narcan — to treat overdose patients, but the drug must be administered quickly to save patients.
The new vaccine would be offered to drug addicts, the researchers suggest, and would hopefully provide protection for a significant period of time — with trials in rats showing it triggered protection for at least ten weeks.
Experts have struggled to create a vaccine against fentanyl since the 1970s because — unlike with bacteria or viruses — opioids aren't readily recognized as invaders by our immune systems.
But they have found a potential approach: By attaching a part of the drug to a harmless part of a bacteria that triggers an immune response.
For their vaccine, the researchers have attached part of fentanyl to an enterotoxin, or a chemical made by the bacteria E.coli, that has already been tested in 15 human trials and triggered nearly no side-effects.
It has already been shown to be effective in trials in rats — revealed in November 2022 — where it triggered anti-fentanyl antibodies.
The above graph shows the number of Americans dying from drug overdoses every week. Nearly 2,000 people are still dying from the medical emergencies every week
The above map shows the change in drug overdose deaths by year. Although numbers are falling in many states, they still remain far higher than even just five years ago
In the Phase I trial, the vaccine will be administered to a small number of healthy people who are also opioid addicts.
This is to test whether it is safe to use in humans, check for side-effects and to establish an optimal dose.
It is not clear how many shots participants may receive, but in studies on rats the rodents received three doses administered once every three weeks. The price of a dose is not yet clear.
Researchers say the trials will likely take place in Australia or the Netherlands, although they are also considering options in the US.
But they are expecting challenges during the research because the population it is set to be tested in — drug users — may be difficult to track.
Dr Jay Evans, the director for the Center for Translational Medicine at the University of Montana who is also involved in the research, said: 'Compared to a normal infectious disease clinical trial, it will be more difficult.
'The FDA is pretty adamant that you're not going to test this vaccine in healthy individuals that don't already have some sort of opioid addiction.
'So, we need to target patients in Phase I who have a history of opioid use disorder, and that's a harder population to try to recruit.
'It's going to take longer; the patient population will have more adverse events because they're drug users and they will be harder to track.'
Researchers say the jab will prevent 'highs' from fentanyl, but would do nothing to prevent cravings, withdrawals or to motivate someone to seek clinical care.
Those taking drugs will likely still experience a high, however, they said — but this will be less intense because the fentanyl's action is removed.
It is also not thought to interfere with the action of other drugs such as morphine, meaning those in medical emergencies can still be treated.
The vaccine was bought by start-up Ovax in November 2023, with the company now having raised $10million to fund further research.
Results from animal studies showed a significant jump in antibody levels against the drug between weeks four and six, and then consistent protection from the fourth to the tenth and final week of the study.
Fentanyl is toxic in even miniscule amounts, data shows — with overdoses risking someone stopping breathing and depriving the brain of oxygen, which can lead to death or permanent disability.