Improving the Efficacy of Anti-Nicotine Immunotherapy (PETNic002)

This study has been completed.
Sponsor:
Collaborators:
Wake Forest School of Medicine
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Alexey Mukhin, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01280968
First received: November 16, 2010
Last updated: January 29, 2014
Last verified: January 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Basic Science
Condition: Nicotine Dependence
Interventions: Biological: NIC002 in Aluminum hydroxide (Alum)
Biological: Placebo Vaccine - Aluminum hydroxide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    NIC002 Vaccine in Aluminum Hydroxide     Placebo Vaccine - Aluminum Hydroxide  
STARTED     45     7  
COMPLETED     27     4  
NOT COMPLETED     18     3  
Lost to Follow-up                 8                 2  
Unable to Follow Experimental Protocol                 2                 0  
Commuting Problems                 2                 0  
Anxiety                 2                 0  
Adverse Event                 1                 0  
Scheduling Conflicts                 1                 1  
Pre-existing Neurological Condition                 1                 0  
Unable to Smoke in Supine Position                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    NIC002 Vaccine in Aluminum Hydroxide     Placebo Vaccine - Aluminum Hydroxide     Total  
Number of Participants  
[units: participants]
  45     7     52  
Age, Customized [1]
[units: years]
Mean ( Full Range )
  43  
  ( 23 to 56 )  
  44  
  ( 35 to 55 )  
  43  
  ( 23 to 56 )  
Gender  
[units: participants]
     
Female     22     4     26  
Male     23     3     26  
Region of Enrollment  
[units: participants]
     
United States     45     7     52  
Cigarettes Per Day [2]
[units: cigarettes per day]
Mean ( Full Range )
  19  
  ( 10 to 30 )  
  21  
  ( 16 to 30 )  
  19  
  ( 10 to 30 )  
Pack-Years [3]
[units: pack-years]
Mean ( Full Range )
  22  
  ( 4 to 45 )  
  25  
  ( 18 to 32 )  
  22  
  ( 4 to 45 )  
[1] One participant reported that she was 54 at the screening, but after she was consented, it was discovered that she was actually 56. However, the subject was discontinued after the first study visit because she could not use the smoking delivery device; therefore, she received no vaccinations. Safety Event #14 was submitted to Duke IRB to account for this Protocol Deviation in which the subject was out of the age range.
[2] average number of cigarettes participant smokes each day
[3] pack-years that each participant has smoked, calculated by multiplying the number of packs of cigarettes participant smokes each day by number of years participant has smoked



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs   [ Time Frame: measured at week 1 and week 16 ]

3.  Primary:   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 ]

4.  Primary:   Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff   [ Time Frame: measured at week 1 and week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alexey G Mukhin, M.D., Ph.D.
Organization: Duke University Medical Center
phone: Telephone: 919-668-5055
e-mail: amukhin@duke.edu


No publications provided


Responsible Party: Alexey Mukhin, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01280968     History of Changes
Other Study ID Numbers: Pro00019787
Study First Received: November 16, 2010
Results First Received: October 29, 2013
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration