# Production of a Nanoparticle Vaccine to Aid in Smoking Cessation

> **NIH NIH R43** · HAFION, LLC · 2020 · $220,093

## Abstract

SUMMARY
Antibody-mediated therapies are an attractive alternative to current smoking cessation strategies because
antibodies target the drug itself to prevent its crossing the blood brain barrier while exhibiting far fewer side
effects. To date, nicotine vaccines have met with limited success in clinical trials due to their low immunogenicity.
Like most subunit vaccines, they have historically suffered from poor efficacy due to their monomeric nature. Our
approach overcomes this limitation by using Hafion’s polyvalent adjuvant fusion technology (Haf) wherein
optimally sized hyaluronic acid (HA) is conjugated to a subunit vaccine to create a polyvalent HA-antigen
nanoparticle designed for uptake by dendritic cells and subsequent trafficking to germinal centers in the lymph
nodes to elicit maximum immunological memory. This proposal will bring together senior investigators from
Hafion LLC, Design-Zyme LLC, and the University of Kansas. Together, we will combine the recent successes
of a nicotine hapten, a self-adjuvating subunit antigen and the formation of nanoparticles to develop a nicotine
vaccine that provides long-term immunological memory. Our approach improves upon the current design of
nicotine vaccines by purposefully eliciting immunological memory to nicotine. To do this, Hafion is combining (1)
a customized nicotine hapten that will be (2) linked to our proprietary adjuvant + HA complex known to elicit
immunological memory (Design-Zyme LLC) by (3) the attachment of a carrier protein antigen that confers broad
protection against multiple Salmonella serotypes. The S. enterica carrier protein antigen is a subunit vaccine
developed by the Picking Laboratory. The goal of this SBIR is to create a safe, effective nicotine vaccine with
additional bacterial pathogen protection suitable for animal testing and eventual use in FDA clinical trials. This
project will demonstrate feasibility by assembling complete nicotine + Salmonella vaccine nanoparticles which
will then be tested for efficacy, antibody affinity and long-term immunogenicity against nicotine and Salmonella
in Phase I. Phase II of this proposal will involve studies to prepare the vaccine candidate for clinical trials as well
as address larger scale production using GLP and GMP practices.

## Key facts

- **NIH application ID:** 10006930
- **Project number:** 1R43DA050474-01A1
- **Recipient organization:** HAFION, LLC
- **Principal Investigator:** Sean K Whittier
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $220,093
- **Award type:** 1
- **Project period:** 2020-07-01 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10006930

## Citation

> US National Institutes of Health, RePORTER application 10006930, Production of a Nanoparticle Vaccine to Aid in Smoking Cessation (1R43DA050474-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10006930. Licensed CC0.

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