Ask The Expert: Dr. Thomas Kosten Discusses Anti-Drug Vaccines

Featuring Thomas Kosten, MD,
Professor and the Jay H. Waggoner Endowed Chair in the Menninger Department of Psychiatry and Behavioral Sciences at Baylor College of Medicine
Dr. Mark Gold and Dr. Thomas Kosten discuss anti-drug vaccines to treat substance use and addiction.

Q – Congratulations on your career to date and most recent work. Can you explain the idea behind your anti-drug vaccines? Are there any of your papers you’d suggest the reader look at?
A – Abused drugs are far too small to produce antibody responses. The vaccines work by covalently attaching the abused drug to 20 to 30 exposed amino acids on a carrier protein such as tetanus toxoid and then injecting this vaccine into humans to produce antibodies to both the tetanus toxoid and to the abused drug, because the drug now “looks like” part of this toxoid.

Q – Is the idea to block the drug’s reinforcing effects? What about overdose effects? Are each of the vaccines specific to a single drug or class of drugs?
A – Yes, the antibodies block reinforcing effects, but a slower process like overdose is still possible unless the drug is typically taken in very small quantities when abused – such drugs include PCP and fentanyl. These vaccines are highly specific to a class of drugs and have limited cross-reactivity.

Q – What happens if the drug abused is cocaine? Heroin? How would this be preferable to methadone or buprenorphine? Naltrexone?
A – For opiates, naltrexone is a better choice as a broad-spectrum blocker, but it does not effectively block the super-agonists related to fentanyl. However, these high potency agents are ideal targets for vaccine development, which is underway.

Q – How long would a single antidrug vaccine treatment last?
A – These antibodies persist at high levels for about three months and then require a booster vaccination about every three months.

Q – Are there risks that would prevent vaccination of women? Other risks? Adverse effects?
A – There are no specific risks from these tetanus toxoid based vaccines for women, since tetanus vaccine is even given to pregnant women. The antibodies cross over the placenta so that the fetus would also be protected.

Q – Are any approved for use? Why?
A – None are approved for use by the FDA because they have not met the criteria set for efficacy with either cocaine or nicotine. There have been no safety concerns, and a cocaine vaccine, particularly combined with the enhanced cholinesterase, would be the most likely to meet FDA efficacy standards relatively easily.

Q – Many experts think that the current opioid epidemic will be followed by a cocaine epidemic. What treatments exist for a cocaine-dependent patient or those presenting to an ED with a cocaine overdose? Are you developing for cocaine overdose? Cocaine addictions?
A – As suggested above, yes, we have a new and much more potent cocaine vaccine than we previously tested, but we need funds to move it forward. This vaccine combined with the Teva or other enhanced cholinesterases (Indivior also has one) would prevent overdoses.

Q – What about methamphetamine?
A – We have a methamphetamine vaccine and hope to have it in humans within a year or so, if our funding continues from NIDA.

Q – What kinds of studies are you doing right now? Planning?
A – The studies are all in animals with methamphetamine, cocaine, nicotine and fentanyl vaccines using a highly effective new adjuvant that has been used in humans at 50 times the dose needed for raising our antibody levels up to sevenfold higher than our previous cocaine vaccine.

Q – Anything else to add?
A – You covered it all, just send money. This is a difficult area for getting venture capital as well as NIDA funds to manufacture and get initial FDA approval to use these vaccines in humans.

Source: Email from Mark Gold, MD <>  September 2017

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