Weill Cornell Medicine and NewYork-Presbyterian have developed a vaccine to blunt the effects of cocaine and potentially prevent it from reaching the brain. The vaccine, called dAd5GNE, has successfully completed pre-clinical studies and has now advanced to Phase 1 testing in humans.
Investigators are now enrolling active cocaine users in a randomized, double-blind, Phase 1 control study to evaluate the mechanism, effects, and safety of the dAd5GNE vaccine in humans. The trial is looking to enroll 30 subjects, to be divided into 3 consecutive 10-person cohorts: 7 receiving the vaccine and 3 receiving placebo. Investigators will assess efficacy and safety measures, including urine drug screens, EKGs, complete blood counts, anti-cocaine antibodies, self-reports on cocaine cravings, and desire for other drugs and alcohol, through frequent meetings (2–3 times/week) with each subject.
Each participant needs to be cocaine-free for at least 30 days before receiving the vaccine, as tested by frequent urine drug screenings. The first vaccine dose will be administered as an injection in the shoulder, with subsequent boosters given every 4 weeks until 6 total injections have been received. After the last vaccine, subjects will be monitored for 3 months until the study’s conclusion at Week 32. The Phase 1 study is expected to be completed in about 3 years.
The dAd5GNE vaccine is designed to absorb cocaine in the bloodstream before its ability to pass through the blood-brain barrier. It works by linking a cocaine-like molecule (GNE) to a disrupted protein of an inactive adenovirus virus, likely producing an immune response that will produce anti-cocaine antibodies.