Researchers at Columbia University are currently running a phase 1a/1b trial for an experimental opioid vaccine – the first of its kind.
In 2020, the US Centers for Disease Control and Prevention (CDC) reported a record 87,000 deaths from drug overdose. Nearly 70% of these deaths occurred due to opioids. Moreover, overdose deaths involving synthetic opioids such as fentanyl has increased 12-fold since 2013. The increase in deaths has not only occurred in adults but also in children. The opioid epidemic, therefore, is of great concern to researchers and doctors. As a result, researchers have now developed the first experimental opioid vaccine for the treatment of opioid use disorder.
Developed by Professor Marco Pravetoni at the University of Minnesota Medical School, the vaccine is currently undergoing phase 1a/1b clinical trials.
Typically, doctors rely on medication-assisted therapy (MAT) for treating opioid use disorder and preventing death from overdose. MAT involves the use of medication (methadone, buprenorphine, or naltrexone) and therapy. However, despite the options, half the people who use the medications relapse after six months. Therefore, a vaccine remains the best option in combating this epidemic.
A vaccine that lasts for several months, given in combination with any of these medications, could help many more people beat their addiction and potentially protect them from an overdose death if a patient relapses.
Professor Sandra Comer, principal trial investigator
Designed to Prevent a ‘High’
The clinical trial is currently enrolling opioid users that are not undergoing any treatments for an opioid use disorder. The researchers aim to divide the participants into three groups: a control group receiving a placebo, one group receiving a low dose of the vaccine, and another receiving a high dose. The results of the trial will then help assess the safety and efficacy of the vaccine.
The experimental vaccine works by triggering the production of antibodies specifically against oxycodone. Oxycodone is a commonly abused prescription opioid painkiller, abused by more than 13 million Americans.
The generated antibodies prevent the drug from crossing the blood-brain barrier and creating the feeling of euphoria or a ‘high’ state. Moreover, the vaccine also helps prevent death from overdose as the drug is unable to act on the brain and cause respiratory depression.
However, there is a slight drawback. The current vaccine only works against oxycodone and will only be useful in individuals abusing that particular drug. Since other opioids have different chemical structures, researchers will have to develop separate vaccines for those. But, thankfully, the vaccine does not interfere with other opioid-based medications such as naloxone. Naloxone helps resuscitate patients who have overdosed, in an emergency setting.
Clinicians would be able to give the oxycodone vaccine to individuals who mainly use that particular drug but could also administer additional opioid vaccines for those who use other opioids or to prevent patients from switching to another opioid.
Professor Sandra Comer, principal trial investigator
Source: Columbia University Irving Medical Center
