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Experimental heroin-prevention vaccine being tested in Syracuse

By OLIVIA BELANGER | Watertown Daily Times, N.Y. | Published: January 11, 2019

SYRACUSE (Tribune News Service) — The latest tactic in fighting the heroin epidemic is a vaccine aimed to prevent users from getting addicted to and high on the drug.

Upstate Medical University is part of a research project for the vaccine, developed by researchers in the Walter Reed Army Institute of Research's Military HIV Research Program in Maryland, and the National Institute on Drug Abuse. During preclinical studies, the vaccine produced antibodies that stopped heroin from entering the brains of mice and rats for up to three months.

Using vaccines to combat addiction got a lot of attention in 2017 when Tom Price, President Trump's former U.S. health and human services secretary, touted them in a news conference. Other research groups also are working on developing heroin vaccines. The Scripps Research Institute in California announced last year its vaccine is almost ready for human testing. Minneapolis Medical Research Foundation is also in the process of development.

Dr. Stephen J. Thomas, spearheading the research and chief of infectious diseases division at the university, said the vaccine replicates the active metabolite of heroin, attached with other materials, making the body develop antibodies against it. This, in turn, tricks the body into rejecting heroin when it's used next, preventing it from having psychoactive effects.

The university, as well as the institute, received a $3.7 million grant – the first part of a two-part grant from the National Institute of Drug Abuse – to finalize vaccine packaging and strategies for human trials. If approved by the U.S. Food and Drug Administration, the second part of the grant will be received for the vaccine to be tested on human volunteers at the university, being applied for later this year.

"Our goal is to be vaccinating the first volunteer in 2020," Dr. Thomas said.

Before taking the position at the university, Dr. Thomas served in the Army for 20 years as an infectious-disease physician scientist, then spent 14 years as a researcher at the institute. Dr. Thomas said he was very familiar with the heroin vaccine research because of this, so when he arrived in Syracuse and saw the growing opioid epidemic reflected in his patients, he knew he had to intervene.

"Probably 10 to 15 percent of my patients are people with complications with drug abuse," Dr. Thomas said.

Jefferson County recorded eight opioid-related deaths in 2018; the toll has continued to decrease since the county's peak of 16 in 2016, according to data collection starting in 2000. In Lewis County, 11 overdose deaths were recorded between 2016 and 2017. St. Lawrence County recorded 24 substance abuse-related deaths, including both drugs and alcohol, in 2018.

New York's drug death toll spiked last year to 4,157 overdose deaths. Nationally, the epidemic caused more than 72,000 overdose deaths in 2017.

Dr. Thomas contacted the institute about the heroin vaccine to see if the university could be a part of the research and a human trial base.

He said with any drug or vaccine developed there will be both risks and benefits. For this vaccine, one of the downsides is though it is directed toward heroin, it's possible it could cross-react with another opioid.

"Hypothetically, we could say this prevents you not only from euphoria of heroin, it could also work on fentanyl, which is safe and effective when used for legitimate medical reasons," Dr. Thomas said. "If you get the vaccine, it's possible you could no longer receive fentanyl if needed."

Dr. Thomas also said he's unsure if withdrawal symptoms will occur or be prevented if an addict takes the vaccine.

The human trial results, ranging from 30 to 100 volunteers who vary from people without histories of substance abuse, people recovering from addiction and people still using heroin, may answer these questions. He said his research team is trying to minimize these risks by finding the optimal person to receive the vaccine during the human trials.

The vaccine would likely be used in a rehabilitation setting, combined with other types of treatment, Dr. Thomas said. Unlike other vaccines, he doesn't believe it'll be put to use as a precautionary measure.

"This is not going to be a magic bullet," Dr. Thomas said. "People who use heroin, it's a symptom of a much deeper problem which requires counseling, behavioral health interventions and suboxone. This will only be one tool in a much larger toolbox."

If the FDA approves the human trial phase, Dr. Thomas said the research plans will go before an ethical review committee to answer both ethical and regulatory questions regarding these types of vaccines.

"There aren't a lot of human trials that have been done with vaccines like this, so we plan on having a multi-perspective course on this to talk, deliberate and have a very informed first step into human testing," he said.

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