The fentanyl vaccine developed by researchers at the University of Houston is expected to enter clinical trials sometime mid-next year and is expected to be a breakthrough solution to the deadly crisis.
The vaccine has been successful in animal studies and is designed to prevent highly addictive opioids from entering the brain and causing overdoses. Biopharmaceutical startup Ovax received a license to produce and test the vaccine in November 2023 and raised more than $10 million for it in June.
“We are all very excited,” said Collin Gage, co-founder and CEO of the startup. He added that his company was starting from a “zero basis” but he believed the fentanyl vaccine would one day be made available to the public.
That day may be a long time later. While public health emergencies like the COVID-19 pandemic can accelerate vaccine development, testing new vaccines can take 5 to 10 years, sometimes longer.
Meanwhile, the number of fentanyl overdose deaths in Texas has been rising, from less than 80 in 2014 to nearly 2,300 in 2023, according to the Texas Department of Health Services. This synthetic opioid is illicitly manufactured but can also be obtained by prescription and is 50 times stronger than heroin and 100 times stronger than morphine, making it the most deadly drug in the opioid crisis.
For fentanyl vaccines, adjuvant is the key
Since the 1970s, the idea of creating an opioid vaccine has attracted the attention of the scientific community. Unlike bacteria or viruses, opioids are not recognized by our immune system as foreign invaders. But the immune system can be trained to produce antibodies against opioids such as fentanyl, using vaccines to link drug fragments to non-infectious bacterial fragments, and using substances called adjuvants.
Adjuvants are designed to enhance the immune response and are particularly important for vaccines against substance use disorders. Jay Evans, director of the University of Montana’s Center for Translational Medicine, said past attempts to make these vaccines have been unsuccessful, in part because adjuvants are not effective enough. Evans is also chief scientific and strategy officer at Inimmune Biotech in Montana, which develops and tests a variety of vaccines, including against fentanyl and heroin addiction.
The adjuvant in the University of Houston fentanyl vaccine is an enterotoxin, a chemical produced by Escherichia coli that has been modified to be non-infectious. Colin Haile, associate professor of psychology at the University of Houston who is responsible for the development of the fentanyl vaccine, said it was first developed in the early 2000s at Tulane University in Louisiana and has been used in multiple vaccines. Haile is also a co-founder and consultant to Ovax.
“It has been conducted in 15 human clinical trials in conjunction with other vaccines,” he said, referring to the adjuvant used in his team’s vaccine. “The results of the studies done on infants were very good, with few side effects.”
Other researchers, such as Ovax co-founder David Dowling and Dr. Ofer Levy, are using adjuvants that have not yet been tested in humans, but at least based on animal studies, they appear to be effective in enhancing the immune response of vaccines against drug abuse disorders. , Dowling said.
Challenging clinical trials
Phase I clinical trials of the University of Houston vaccine are planned to begin in the second quarter of 2025. Ovax is also in licensing negotiations with Boston Children’s Hospital for a fentanyl vaccine developed by Dowling and Levy. If these negotiations are successful, Phase 1 clinical trials may begin in early 2026.
These trials aim to determine the safety level, potential side effects and optimal dose of the vaccine. Evans said finding people to participate will be a challenge.
“This will be more difficult than normal clinical trials for infectious diseases. The FDA (U.S. Food and Drug Administration) believes very firmly that you will not test this vaccine addiction in healthy individuals who have not yet taken an opioid,”he said.
“So we need to target stage 1 patients with a history of opioid use disorder, a more difficult population to recruit. It will take longer; there will be more adverse events in the patient population because they are drug users and they will be more difficult to track.”
Evans added that the stigma of addiction and drug use may discourage people from revealing their condition and participating in clinical trials.
Gage said Ovax had not yet decided where it planned to conduct the Phase I clinical trial, but it had been considering locations in Australia and the Netherlands.
“We also look in the United States,” he said,”but it’s difficult to find the right patient group.”
Future clinical trials need to determine the effectiveness of the vaccine, who will benefit the most, and how long immunity will last.
Vaccines as part of the solution
Some critics of the fentanyl vaccine say it draws resources from existing opioid addiction therapies such as buprenorphine, methadone and naltrexone. Some people question whether people will seek vaccines.
“People have to say they want injections, and they have to choose whether to continue coming back with each injection or infusion,” Keith Humphreys, professor of psychiatry and behavioral sciences at Stanford University, told the Washington Post in 2023. Don’t take anything to reduce cravings or withdrawal, or to inspire anyone to return for more care.”
For Haier, the fentanyl vaccine is not the only solution, but another weapon in the fight against the opioid crisis. He and colleagues at the University of Houston conducted animal studies to investigate how vaccines affected treatment of buprenorphine, a drug commonly used to control withdrawal and drug cravings.
Haier said the results have not yet been published but are “quite impressive” and noted that the fentanyl vaccine could improve the effectiveness of existing treatments.
“The most important thing to remember is that we are taking action as quickly as possible… we need to get the product to market as quickly as possible to solve this terrible problem,” Haier said. “The ultimate goal is to protect people and save lives.”
From: 2024 Dallas Morning News.
For more content, you can click on the link below the video
Thank you for watching this video. If you like it, please subscribe and like it. thank
Original text:https://medicalxpress.com/news/2024-09-fentanyl-vaccine-clinical-trials-goal.html
Oil tubing: