Study of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation

Summary

Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers; but for smokers who can quit there is an immediate and significant beneficial impact on their health and life expectancy. Cigarette smoking remains the leading preventable cause of death in the United States (US), accounting for approximately 1 of every 5 deaths (438,000 people) each year.

This Phase 2 study will investigate the efficacy and tolerability of 2 doses of TA-NIC compared to placebo as an aid to smoking cessation in smokers who are motivated to quit.

Conditions

• Smoking

Interventions

BIOLOGICAL

TA-NIC

TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.

BIOLOGICAL

Placebo

Placebo will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.

Sponsors & Collaborators

• Celtic Pharma Development Services

  lead INDUSTRY

Principal Investigators

• Krefetz · CNS Research Institute, P.C

• Gruener · CRI Worldwide, LLC

• Coats · Benchmark Research

• Rarick · Benchmark Research

• Seger · Benchmark Research - Fort Worth

• Jeanfreau · Benchmark Research

• Geller · Centennial Medical Group

• Saway · Columbia Medical Practice

• Dale · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-05-31

Primary Completion

2008-12-31

Completion

2009-02-28

Countries

• United States

Study Locations