Improving the Efficacy of Anti-Nicotine Immunotherapy

NCT01280968 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00019787
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to find out how vaccine-induced antibodies change the way the body processes nicotine from cigarettes. These antibodies absorb nicotine and can reduce nicotine levels in the brain. In this way, the vaccination may help to quit smoking. The central hypothesis is that anti-nicotine antibodies change kinetics of brain nicotine accumulation and distribution of nicotine between the brain and other body tissues. This vaccine is investigational which means that it is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) to help people quit smoking.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (4)

• Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs

  There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.

  measured at week 1 and week 16

• Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs

  There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.

  measured at week 1 and week 16

• Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs

  There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.

  measured at week 1 and week 16

• Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff

  measured at week 1 and week 16

Study Arms (2)

NIC002 Vaccine in Aluminum hydroxide

EXPERIMENTAL

4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.

Biological: NIC002 in Aluminum hydroxide (Alum)

Placebo Vaccine - Aluminum hydroxide

PLACEBO COMPARATOR

4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.

Biological: Placebo Vaccine - Aluminum hydroxide

Interventions

NIC002 in Aluminum hydroxide (Alum) BIOLOGICAL

Fifty-five subjects will receive 4 subcutaneous injections of 0.1 mg Nicotine-QB (NIC002) in Alum vaccine with a 4-week interval between injections.

Also known as: CYT002-NicQb (Nicotine-Qbeta), Anti-Nicotine Vaccine

NIC002 Vaccine in Aluminum hydroxide

Placebo Vaccine - Aluminum hydroxide BIOLOGICAL

Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.

Placebo Vaccine - Aluminum hydroxide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Smoked an average of at least 10 cigarettes per day for the past year
• Have an expired air Carbon Monoxide (CO) reading of at least 15 ppm
• Express a desire to quit smoking in the next three to four months.
• Potential subjects must agree to use acceptable contraception during their participation in this study.
• Potential subjects must agree to avoid the following during their participation in this study:
• participation in any other nicotine-related modification strategy outside of this protocol
• use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chewing tobacco
• use of experimental (investigational) drugs or devices;
• use of illegal drugs;
• use of psychiatric medications;
• use of opiate medications;
• use of systemic steroids or other immunosuppressive agents.

You may not qualify if:

• Hypertension (systolic \>140 mm Hg, diastolic \>100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
• Hypotension with symptoms (systolic \<90 mm Hg, diastolic \<60 mm Hg).
• Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
• Coronary heart disease or other cardiovascular disorder;
• Lifetime history of heart attack;
• Cardiac rhythm disorder (irregular heart rhythm);
• Chest pains (unless history, exam, and Electrocardiogram (ECG) clearly indicate a non-cardiac source);
• Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
• Liver or kidney disorder (except kidney stones, gallstones);
• Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
• Active ulcers in the past 30 days;
• Lung disorder (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
• Brain abnormality or other neurological disorder (including but not limited to stroke, brain tumor, and seizure disorder);
• Recent, unexplained fainting spells;
• Problems giving blood samples;

Sponsors & Collaborators

• Alexey Mukhin: lead
• Wake Forest University Health Sciences: collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (2)

Duke Center for Nicotine & Smoking Cessation Research

Durham, North Carolina, 27705, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Aluminum Hydroxide; aluminum sulfate; nicotine Qbeta vaccine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Results Point of Contact

• Title: Alexey G Mukhin, M.D., Ph.D.
• Organization: Duke University Medical Center

amukhin@duke.edu

Telephone: 919-668-5055

Study Officials

• Alexey G Mukhin, M.D., Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Science

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: January 21, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: April 1, 2013
• Last Updated: March 5, 2014
• Results First Posted: December 18, 2013

Record last verified: 2014-01

Locations

US (2)