Sept. 7, 2023 – “We anticipate testing our vaccines in humans in early 2024,” Dr Jay Evans, study author and director of the University of Montana’s Center for Translational Medicine, said in a statement. 

“The human clinical trials will include a drug challenge to evaluate both safety and efficacy of the vaccines in early clinical development. We will also follow the patients to evaluate how long the antibodies against opioids will last,” he said.

“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,” added Evans. 

The vaccines in question will use toll-like receptors (TLR7/8) which typically play an important role in the immune response to viral infections. The team’s vaccine also utilizes the power of an adjuvant called INI-4001, which boosts the effectiveness of vaccines.

Speaking to IFLScience, Evans explained that the vaccines could provide immunity against an overdose for a number of years, although that still needs to be determined by their human trials.