First-in-human clinical trial for a vaccine to treat opioid use disorders enrolls first patients
September 07 2021 - 8:30AM
The first patients have been enrolled in a phase 1 randomized
placebo-controlled clinical trial to study a therapeutic vaccine
for opioid use disorder developed by researchers at the University
of Minnesota Medical School.
Funded by a grant from the National Institutes of Health, the
trial will test the safety and potential efficacy of a vaccine that
is designed to selectively prevent the euphoric and toxic effects
of oxycodone.
Volunteers for the trial are being enrolled at Columbia
University in New York City and Clinilabs Drug Development
Corporation, based in Eatontown, New Jersey.
Marco Pravetoni, PhD, a leading expert of biologics for the
treatment of substance use disorders and developer of the vaccine
candidate, is an associate professor of pharmacology and medicine
at the University of Minnesota Medical School. His laboratory led
the development of a series of vaccines and monoclonal antibodies
effective in counteracting respiratory depression (depressed
breathing) and bradycardia (depressed heart rate) induced by
oxycodone, fentanyl and heroin in preclinical studies, as published
in the Journal of Pharmacology and Experimental
Therapeutics and the Journal of Medicinal Chemistry.
The vaccine currently being tested stimulates the body’s immune
system to produce antibodies to oxycodone. If someone who has been
vaccinated takes oxycodone, those antibodies would bind to the drug
molecule, stopping it from entering the brain and, ultimately,
preventing the “high” produced by the drug. Because of its
selectivity for oxycodone, the vaccine will not interfere with
FDA-approved medications, including methadone, buprenorphine,
naltrexone and naloxone, potentially offering a long-lasting, safe
and cost-effective alternative that is complementary to standard
medical intervention for opioid use disorders.
“In this study, my laboratory will conduct pharmacokinetic and
immunological monitoring in blood samples from immunized volunteers
to ensure that they are making antibodies to oxycodone and
determine whether or not the antibodies are preventing the drug
from reaching the brain,” said Pravetoni, who is also a member of
the U of M Medical School’s Medical Discovery Team on
Addiction.
Sandra Comer, PhD, director of the Opioid Laboratory in the
Division on Substance Use Disorders in the Department of Psychiatry
at Columbia University Vagelos College of Physicians and Surgeons,
is the principal investigator of the study. Comer will oversee a
team of physicians and nurses led by Jeanne Manubay, MD, the
study’s medical director, who is monitoring the patients’ response
to the vaccine, including their subsequent drug use and behaviors.
She has nearly three decades of experience in developing
medications for treating opioid and other substance use disorders
and provides overall scientific and regulatory oversight of the
clinical trial.
“This medication approach is unique in that it can be used alone
or in combination with other treatment medications and,
importantly, may offer patients long-lasting protection against
overdose if they relapse to opioid use,” Comer said. “The long-term
goal of this program is to develop a series of opioid vaccines that
target other commonly used opioids, such as heroin and fentanyl. We
are very excited about this research and hope to eventually provide
a safe, new treatment option for patients with opioid use
disorder.”
The study seeks volunteers who:
- Are between the ages of 18-59;
- Are currently using opioids and not seeking treatment for drug
use; and,
- Have prior experience with intranasal opioid use.
The study plans to enroll up to 45 volunteers. Volunteers will
be closely monitored for several weeks on inpatient units at
Columbia University Irving Medical Center and at Clinilabs to look
for adverse events and determine their response to oxycodone after
vaccination, before studying their drug behavior on an outpatient
basis.
“Clinilabs is privileged to be working with the University of
Minnesota Medical School and Columbia University on this
groundbreaking trial. Exploring a preventative vaccine to treat
opioid use disorder has the potential to be life-altering for
patients and their families who are battling opioid abuse,” said
Gary Zammit, Clinilabs’ President and CEO.
To learn more about the study or to review the volunteer
qualifications, call 646-774-6243 or
visit https://recruit.cumc.columbia.edu/clinical_trial/2168.
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Research reported in this press release was supported by The
National Institute on Drug Abuse of the National Institutes of
Health under award number UG3DA047711. The total project cost is
financed with federal dollars. The content of this press release is
solely the responsibility of the authors and does not necessarily
represent the official views of the National Institutes of
Health.
About the University of Minnesota Medical
SchoolThe University of Minnesota Medical School is at the
forefront of learning and discovery, transforming medical care and
educating the next generation of physicians. Our graduates and
faculty produce high-impact biomedical research and advance the
practice of medicine. We acknowledge that the U of M
Medical School, both the Twin Cities campus and Duluth campus, is
located on traditional, ancestral and contemporary lands of the
Dakota and the Ojibwe, and scores of other Indigenous people, and
we affirm our commitment to tribal communities and their
sovereignty as we seek to improve and strengthen our relations with
tribal nations. For more information about the U of M Medical
School, please visit med.umn.edu.
Photos and videos from the Pravetoni Lab
are available for media use. Credit should be given to Lisa
Anderson, University of Minnesota Medical School.
Angel Mendez
University of Minnesota Medical School
mende434@umn.edu
