Safety and immunogenicity of a nicotine conjugate vaccine in current smokers
Abstract
Immunotherapy is a novel potential treatment for nicotine addiction. The aim of this study was to assess the safety and immunogenicity of a nicotine conjugate vaccine, NicVAX, and its effects on smoking behavior. Smokers (N = 68) were recruited for a noncessation treatment study and assigned to 1 of 3 doses of the nicotine vaccine (50, 100, or 200 microg) or placebo. They were injected on days 0, 28, 56, and 182 and monitored for a period of 38 weeks. Results showed that the nicotine vaccine was safe and well tolerated. Vaccine immunogenicity was dose-related (P < .001), with the highest dose eliciting antibody concentrations within the anticipated range of efficacy. There was no evidence of compensatory smoking or precipitation of nicotine withdrawal with the nicotine vaccine. The 30-day abstinence rate was significantly different across the 4 doses (P = .02), with the highest rate of abstinence occurring with 200 microg. The nicotine vaccine appears to be a promising medication for tobacco dependence.
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Early phase 1/2 clinical trials in humans have demonstrated drug safety, effective immunogenicity, and promising increases in abstinence rates, especially among individuals with higher levels of anti-nicotine IgGs.
“Early phase 1/2 clinical trials in humans have demonstrated drug safety, effective immunogenicity, and promising increases in abstinence rates, especially among individuals with higher levels of anti-nicotine IgGs [253–256].”
From Mechanistic insights into nicotine withdrawal (2011) · cites this paper as [254]
Early phase 1/2 clinical trials in humans have demonstrated drug safety, effective immunogenicity, and promising increases in abstinence rates, especially among individuals with higher levels of anti-nicotine IgGs.
“Early phase 1/2 clinical trials in humans have demonstrated drug safety, effective immunogenicity, and promising increases in abstinence rates, especially among individuals with higher levels of anti-nicotine IgGs [253–256].”
From Mechanistic insights into nicotine withdrawal (2011) · cites this paper as [255]
Anti-nicotine vaccination in rats prolongs the half-life of nicotine by 3 to 6 fold.
“Furthermore, anti-nicotine vaccination in rats has been found to prolong the half-life of nicotine by 3 to 6 fold (133)”
From Tobacco addiction (2008) · cites this paper as [133]
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References 20 · Cited by 194
- Authors
- HATSUKAMI, D., RENNARD, S., JORENBY, D., FIORE, M., KOOPMEINERS, J., DEVOS, A., HORWITH, G., & PENTEL, P.
- Affiliations
- University of Minnesota (US)
- ORCID
- Venue
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2005-11
- Volume
- 78
- Issue
- 5
- Pages
- 456-467
- ISSN
- 0009-9236 (ISSN-L)
- OpenAlex
- W2017295068
- Cited by
- 194
- References
- 20
- Citations by year
- 2025: 4 · 2024: 2 · 2023: 7 · 2022: 3 · 2021: 4 · 2020: 2 · 2019: 5 · 2018: 5 · 2017: 2 · 2016: 9 · 2015: 8 · 2014: 8 · 2013: 15 · 2012: 15
- FWCI
- 11.63
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5p50da013333-10, 1u19da013327-01)
- National Institute on Drug Abuse (U19 DA13327, P50- DA013333)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Keywords
- nicotine dependence, tobacco dependence, smoking cessation, vaccine immunogenicity, vaccine safety, dose-response relationship, smoking abstinence, nicotine withdrawal, compensatory smoking
- MeSH terms
- Smoking Prevention, Adult, Antibodies, Dose-Response Relationship, Drug, Double-Blind Method, Female, Haptens, Humans, Immunotherapy, Male, Middle Aged, Nicotine, Smoking, Substance Withdrawal Syndrome, Tobacco Use Disorder, Vaccines, Survival Analysis, Smoking Cessation
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