A fentanyl vaccine developed by researchers on the University of Houston is scheduled to enter clinical trials in the course of next yr and is anticipated to supply a groundbreaking solution to a deadly crisis.
The vaccine, which has been successful in animal testing, is designed to stop the highly addictive opioid from entering the brain and causing an overdose. Biopharmaceutical startup Ovax acquired the license to fabricate and test the vaccine in November 2023 and raised over $10 million for the project by June.
“We are all incredibly excited,” said Collin GageCo-founder and CEO of the startup. He added that his company is starting “from scratch,” but he’s confident that in the future it is going to have a fentanyl vaccine available to the general public.
That day could also be a protracted time coming. While health emergencies reminiscent of the COVID-19 pandemic can speed up the event of a vaccine, can take between five and ten years — sometimes longer.
In the meantime, Fentanyl overdose deaths increase in Texasfrom lower than 80 in 2014 to almost 2,300 in 2023, in accordance with the Texas Department of State Health ServicesThe synthetic opioid – produced illegally but in addition prescription-only – is 50 times stronger than heroin and 100 times stronger than morphinemaking it the deadliest drug within the opioid crisis.
Adjuvants are crucial for fentanyl vaccines
The idea of developing an opioid vaccine has scientific attention because the Nineteen SeventiesUnlike bacteria or viruses, opioids are usually not recognized by our immune systems as foreign invaders. However, the immune system could be trained to make antibodies in response to an opioid reminiscent of fentanyl. This could be achieved through a vaccine that mixes parts of the drug with non-infectious parts of bacteria and uses substances called adjuvants.
Adjuvants are designed to reinforce the immune response and are particularly necessary in vaccines against substance use disorders. Previous attempts to supply such vaccines were partly unsuccessful since the adjuvants weren’t effective enough, said Jay EvansDirector of the Center for Translational Medicine on the University of Montana. Evans can also be the scientific and strategic director of Immunea Montana-based biotech company that develops and tests quite a lot of vaccines including those aimed toward combating fentanyl and heroin addiction.
The adjuvant within the University of Houston’s fentanyl vaccine is an enterotoxin, a chemical produced by the bacteria Escherichia coli and modified to be non-infectious. It was first developed at Tulane University in Louisiana within the early 2000s and has been utilized in quite a lot of vaccines, said Colin Hailea research fellow in psychology on the University of Houston who led the event of the fentanyl vaccine. Haile can also be a co-founder and advisor to Ovax.
“It has been tested in 15 human clinical trials in combination with other vaccines,” he said, referring to the adjuvant utilized in his team's vaccine. “There have been studies in infants where the results have been fantastic, almost no side effects.”
Other researchers like David Dowling And Dr. Ofer Levyeach co-founders of Ovax, use adjuvants which have not been tested in humans but, at the very least based on animal studies, seem like effective in enhancing the immune response to vaccines against substance-related disorders, Dowling said.
Clinical trials filled with challenges
Phase 1 clinical trials for the University of Houston vaccine are expected to start within the second quarter of 2025. Ovax can also be in licensing negotiations with Boston Children's Hospital for a fentanyl vaccine developed by Dowling and Levy. If those negotiations are successful, Phase 1 clinical trials could begin in early 2026.
The aim of those studies is to find out the effectiveness of the vaccine. Safety level, possible unwanted effects and optimal dosage. Finding people to participate can be a challenge, Evans said.
“Compared to a normal infectious disease clinical trial, it's going to be more difficult. The FDA (Food and Drug Administration) is insisting that this vaccine not be tested in healthy individuals who don't already have some sort of opioid addiction,” he said. “So in Phase 1, we have to target patients who have a history of opioid use disorder, and that's a harder patient group to recruit. It's going to take longer; the patient group is going to have more side effects because they're using drugs, and they're going to be harder to follow.”
Evans added that the stigma surrounding addiction and drug use can result in people being unwilling to speak about their illness and take part in clinical trials.
Ovax has not yet decided where it is going to conduct its Phase 1 clinical trials, Gage said, but is considering sites in Australia and the Netherlands.
“We are also looking in the United States,” he said, “but it is difficult to find the right patient group.”
Future clinical trials would wish to find out the effectiveness of the vaccine to find out who would profit most and the way long immunity lasts.
Vaccines as a part of the answer
Some critics of fentanyl vaccines say they divert resources from existing treatments for opioid addiction reminiscent of buprenorphine, Methadone And NaltrexoneSome have questioned whether people would get vaccinated.
“People have to say they want a shot, and they have to decide to come back for each injection or infusion,” Keith HumphreysProfessor of Psychiatry and Behavioral Sciences at Stanford University, told the Washington Post in 2023. “The vaccines do nothing to reduce cravings or withdrawal symptoms or motivate someone to come back for further treatments.”
For Haile, a fentanyl vaccine isn’t the one solution, but one other weapon within the fight against the opioid crisis. He and his colleagues on the University of Houston have conducted animal studies to look at how the vaccine affects treatment with buprenorphine, a drug commonly prescribed to treat withdrawal symptoms and drug cravings. The results have yet to be published, but are “pretty impressive,” Haile said, noting that fentanyl vaccines could improve the effectiveness of existing treatments.
“The most important thing is that we move as quickly as possible. … We need to get something to market as quickly as possible to address this terrible problem,” Haile said. “The ultimate goal is to protect people and save lives.”
image credit : www.mercurynews.com