The NIH has awarded $2.3M for a pilot project, led by Boston Children's Hospital, to develop a vaccine that would protect people with opioid use disorder against an accidental fentanyl overdose. Fentanyl is responsible for a rising number of opioid deaths, and opioid users may not be aware that their drugs are laced with fentanyl.
The two-year project, which begins enrolling patients this month, is co-led by Ofer Levy, MD, PhD and David Dowling, PhD, of the Precision Vaccines Program at Boston Children's Hospital, as well as Sharon Levy, MD, MPH, director of the Adolescent Substance Use and Addiction Program (ASAP) at Boston Children's. They will collaborate with the University of Houston and Inimmune, a Montana-based company focused on immunotherapeutics.
The investigators aim to enroll 20 to 25 patients from the ASAP program with a history of an opioid use disorder, ages 12 to 30, and a similar number of controls. Subjects will provide blood samples that will be used in assays that replicate key aspects of the human immune system. These model assays will be used to test responses to candidate vaccines and adjuvants (components added to vaccines to boost and prolong their efficacy), and to compare responses in immune systems of different ages and different histories of opioid exposure.
The vaccine would be designed to induce antibodies in the blood that block fentanyl from getting into the brain. Once a lead vaccine/adjuvant formulation is identified in the human immune assays, it would then be tested in mouse models at the University of Houston. The investigators are applying for a larger federal contract to eventually test the vaccine in humans.
While the vaccine work proceeds, in collaboration with Elissa Weitzman, ScD of the Adolescent Medicine Division at Boston Children's, the study will also interview participants to determine their attitudes about potentially receiving an opioid vaccine. Future work will explore the possibility of protecting against accidental overdose of opiates other than fentanyl, and whether an opioid vaccine might benefit substance users more broadly.
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The project is jointly funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute on Drug Abuse (NIDA).