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Improving the Efficacy of Anti-Nicotine Immunotherapy (PETNic002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01280968
Recruitment Status : Completed
First Posted : January 21, 2011
Results First Posted : December 18, 2013
Last Update Posted : March 5, 2014
Sponsor:
Collaborators:
Wake Forest University Health Sciences
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Alexey Mukhin, Duke University

Tracking Information
First Submitted Date  ICMJE November 16, 2010
First Posted Date  ICMJE January 21, 2011
Results First Submitted Date  ICMJE October 29, 2013
Results First Posted Date  ICMJE December 18, 2013
Last Update Posted Date March 5, 2014
Study Start Date  ICMJE December 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2014)
  • Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs [ Time Frame: measured at week 1 and week 16 ]
    There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
  • Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs [ Time Frame: measured at week 1 and week 16 ]
    There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
  • Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs [ Time Frame: measured at week 1 and week 16 ]
    There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
  • Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff [ Time Frame: measured at week 1 and week 16 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2011)
Kinetics of nicotine distribution during cigarette smoking: Initial rate and T1/2 of nicotine washout from the lungs; and initial rate T1/2 maximal concentration and area under curve for nicotine accumulation in brain and muscles [ Time Frame: Two weeks after last vaccination ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2011)
  • Binding properties of vaccination-induced anti-nicotine antibodies [ Time Frame: Two weeks after last vaccination ]
  • Side effects of vaccination [ Time Frame: After first vaccination until study completion ]
  • Efficacy of vaccine for smoking cessation [ Time Frame: One, two and six months after quit day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving the Efficacy of Anti-Nicotine Immunotherapy
Official Title  ICMJE Improving the Efficacy of Anti-Nicotine Immunotherapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE
  • Biological: NIC002 in Aluminum hydroxide (Alum)
    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.
    Other Names:
    • CYT002-NicQb (Nicotine-Qbeta)
    • Anti-Nicotine Vaccine
  • Biological: Placebo Vaccine - Aluminum hydroxide
    Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.
Study Arms  ICMJE
  • Experimental: NIC002 Vaccine in Aluminum hydroxide
    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.
    Intervention: Biological: NIC002 in Aluminum hydroxide (Alum)
  • Placebo Comparator: Placebo Vaccine - Aluminum hydroxide
    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.
    Intervention: Biological: Placebo Vaccine - Aluminum hydroxide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2013)
52
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2011)
65
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-55 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.

Exclusion Criteria:

  1. 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.
  2. Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).
  3. 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.
  4. Coronary heart disease or other cardiovascular disorder;
  5. Lifetime history of heart attack;
  6. Cardiac rhythm disorder (irregular heart rhythm);
  7. Chest pains (unless history, exam, and Electrocardiogram (ECG) clearly indicate a non-cardiac source);
  8. Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
  9. Liver or kidney disorder (except kidney stones, gallstones);
  10. Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
  11. Active ulcers in the past 30 days;
  12. Lung disorder (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
  13. Brain abnormality or other neurological disorder (including but not limited to stroke, brain tumor, and seizure disorder);
  14. Recent, unexplained fainting spells;
  15. Problems giving blood samples;
  16. Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
  17. Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
  18. Skin disorder;
  19. Autoimmune disease;
  20. Human immunodeficiency virus (HIV) or HIV risk behavior;
  21. Severe allergies;
  22. Other major medical condition;
  23. Current psychiatric disease including major depressive episode, panic attack, psychosis, bipolar disorder or eating disorder;
  24. Pregnant or nursing mothers;
  25. Use (within the past 30 days) of:

    • Illegal drugs (or if the urine drug screen is positive),
    • Experimental (investigational) drugs;
    • Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
    • Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed)
    • Smokeless tobacco (chewing tobacco, snuff), cigars, pipes or e-cigarettes;
    • Nicotine replacement therapy or any other smoking cessation aid.
  26. Alcohol abuse - The AUDIT (Alcohol Use Disorders Identification Test) questionnaire will be used to assess alcohol abuse.
  27. Previous history of negative experiences with "flu" vaccine or any other vaccine.
  28. High chronic exposure to aluminum (occupational or medical);
  29. Pulmonary function test results < 60% of predicted value for FEV1 and FVC;
  30. Body Mass Index > 38kg/m2;
  31. History of psychosis or bipolar disorder;
  32. Prior exposure to CTY002- NicQ or any other nicotine vaccine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01280968
Other Study ID Numbers  ICMJE Pro00019787
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexey Mukhin, Duke University
Study Sponsor  ICMJE Alexey Mukhin
Collaborators  ICMJE
  • Wake Forest University Health Sciences
  • Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Alexey G Mukhin, M.D., Ph.D. Duke University
PRS Account Duke University
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP