A fentanyl vaccine be ready for human trials early next year, according to University of Montana researchers. The vaccine helps the body generate antibodies that prevent the opioids from entering the brain. Without the reinforcing effects of the high, it becomes easier for the user to kick the habit. At the same time, the vaccine reduces the likelihood that an overdose will decrease respiratory rate to the point of death.
"The first vaccine will target heroin, followed shortly thereafter with a fentanyl vaccine in Phase I clinical trials," says University of Montana researcher Jay Evans. Once we establish safety and early efficacy in these first clinical trials, we hope to advance a combined multivalent vaccine targeting both heroin and fentanyl.
From the University of Montana:
He said the Phase 1 trials involve gradual dose escalation.
"We start with the lowest dose – a dose that may not be effective," Evans said. "Phase I clinical trials are focused on safety. When the first dose cohort is complete, a data safety monitoring board reviews the data and approves testing at the next dose level if the vaccine is safe. The process takes time until you reach dose levels that are both safe and effective."
After that, Phase 2 human trials determine things like the number of doses needed to be effective and the amount of time required between doses. Phase 3 is the all-important efficacy study that involves many participants that the FDA uses to determine whether the benefits of the vaccine outweigh potential risks.
"It takes a long time – years – to get to a final approved product," Evans said. "Based on the efficacy data we see in our preclinical data and the established safety profile in animal models, we are very hopeful these vaccines will be successful. But there is still a lot of work to be done."
