An anti-cocaine vaccine that has shown promise in animal research is proceeding to Phase I testing in humans. The dAd5GNE vaccine, developed by researchers at NewYork-Presbyterian and Weill Cornell Medicine, will be tested with 30 active cocaine users in a study funded by the National Institute on Drug Abuse (NIDA).
According to an Aug. 8 news release from the New York institutions, the vaccine links a cocaine-like molecule to a disrupted protein of an inactive virus, producing an immune response. The immune system then activates antibodies that attack the virus and the molecules. This would mean that any subsequent use of cocaine would result in an immediate response from the antibodies.
“The goal of this vaccine is to prevent cocaine from reaching the brain,” said Ronald Crystal, MD, chairman of the Department of Genetic Medicine at Weill Cornell Medicine. “While we know that this works very well in animals, now we need to find out if the vaccine will cause enough anti-cocaine antibodies to be produced so that it works in humans, too.”
Study participants will have to abstain from cocaine use for at least 30 days prior to receiving the first injection (with abstinence to be verified with frequent urine screens), and will receive a total of six injections over the course of the 32-week study. They will meet with researchers at least twice a week for assessment of the vaccine's safety and efficacy.