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Improving the Efficacy of Anti-Nicotine Immunotherapy (PETNic002)

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Condition Nicotine Dependence
Interventions Biological: NIC002 in Aluminum hydroxide (Alum)
Biological: Placebo Vaccine - Aluminum hydroxide
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NIC002 Vaccine in Aluminum Hydroxide Placebo Vaccine - Aluminum Hydroxide
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 45 7
Completed 27 4
Not Completed 18 3
Reason Not Completed
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
Arm/Group Title NIC002 Vaccine in Aluminum Hydroxide Placebo Vaccine - Aluminum Hydroxide Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 45 7 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants 7 participants 52 participants
43
(23 to 56)
44
(35 to 55)
43
(23 to 56)
[1]
Measure Description: 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.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 7 participants 52 participants
Female
22
  48.9%
4
  57.1%
26
  50.0%
Male
23
  51.1%
3
  42.9%
26
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 7 participants 52 participants
45 7 52
Cigarettes Per Day   [1] 
Mean (Full Range)
Unit of measure:  Cigarettes per day
Number Analyzed 45 participants 7 participants 52 participants
19
(10 to 30)
21
(16 to 30)
19
(10 to 30)
[1]
Measure Description: average number of cigarettes participant smokes each day
Pack-Years   [1] 
Mean (Full Range)
Unit of measure:  Pack-years
Number Analyzed 45 participants 7 participants 52 participants
22
(4 to 45)
25
(18 to 32)
22
(4 to 45)
[1]
Measure Description: 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
1.Primary Outcome
Title Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs
Hide Description There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
Time Frame measured at week 1 and week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects NIC002, Tertile With Highest Antibody Binding Capacity Placebo Vaccine - Aluminum Hydroxide
Hide Arm/Group Description:
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.
[Not Specified]
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.
Overall Number of Participants Analyzed 29 10 4
Mean (Standard Error)
Unit of Measure: percentage of change
single cigarette puff 1  (5) -15  (7) -0.2  (7.1)
multiple cigarette puffs 0.1  (5.7) -9  (8) -1.1  (9.6)
2.Primary Outcome
Title Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs
Hide Description There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
Time Frame measured at week 1 and week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects NIC002, Tertile With Highest Antibody Binding Capacity Placebo Vaccine - Aluminum Hydroxide
Hide Arm/Group Description:
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.
[Not Specified]
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.
Overall Number of Participants Analyzed 29 10 4
Mean (Standard Error)
Unit of Measure: percentage of change
single cigarette puff 1  (4) -15  (6) 0  (7.8)
multiple cigarette puffs -0.7  (5.1) -6  (9) -1.3  (9.8)
3.Primary Outcome
Title Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs
Hide Description There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
Time Frame measured at week 1 and week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects NIC002, Tertile With Highest Antibody Binding Capacity Placebo Vaccine - Aluminum Hydroxide
Hide Arm/Group Description:
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.
[Not Specified]
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.
Overall Number of Participants Analyzed 29 10 4
Mean (Standard Error)
Unit of Measure: percentage of change
single cigarette puff 0  (11) 15  (30) -4.4  (9.6)
multiple cigarette puffs -2  (4) 0  (7) 3.8  (11.6)
4.Primary Outcome
Title Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff
Hide Description [Not Specified]
Time Frame measured at week 1 and week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects NIC002, Tertile With Highest Antibody Binding Capacity Placebo Vaccine - Aluminum Hydroxide
Hide Arm/Group Description:
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.
[Not Specified]
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.
Overall Number of Participants Analyzed 29 10 4
Mean (Standard Error)
Unit of Measure: percentage of change
22.5  (12.7) 9  (30) 2.4  (5.9)
Time Frame [Not Specified]
Adverse Event Reporting Description The number of participants at risk is different from the number of enrolled participants because not all participants who were randomized to a vaccine or placebo received treatment. Of the 52 participants who were assigned to a treatment group, only 41 received at least one vaccination. Therefore, 41 participants were at risk.
 
Arm/Group Title NIC002 Vaccine in Aluminum Hydroxide Placebo Vaccine - Aluminum Hydroxide
Hide Arm/Group Description 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. 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.
All-Cause Mortality
NIC002 Vaccine in Aluminum Hydroxide Placebo Vaccine - Aluminum Hydroxide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NIC002 Vaccine in Aluminum Hydroxide Placebo Vaccine - Aluminum Hydroxide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NIC002 Vaccine in Aluminum Hydroxide Placebo Vaccine - Aluminum Hydroxide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/36 (36.11%)      3/5 (60.00%)    
General disorders     
Headache  [1]  3/36 (8.33%)  8 1/5 (20.00%)  1
Weight Changes  [1]  1/36 (2.78%)  2 1/5 (20.00%)  1
Back Pain  [1]  2/36 (5.56%)  2 0/5 (0.00%)  0
Feeling Cold  [1]  3/36 (8.33%)  9 0/5 (0.00%)  0
Feeling Hot  [1]  4/36 (11.11%)  5 0/5 (0.00%)  0
Nasal Congestion  [1]  0/36 (0.00%)  0 1/5 (20.00%)  1
Runny Nose  [1]  0/36 (0.00%)  0 1/5 (20.00%)  1
Sore Throat  [1]  2/36 (5.56%)  2 0/5 (0.00%)  0
Fatigue  [1]  4/36 (11.11%)  11 1/5 (20.00%)  1
Tenderness at Injection Site  [1]  2/36 (5.56%)  2 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
At each of 8 visits following first vaccination visit, participants filled out Side Effects Questionnaire and rated severity of side effect from 1 (not at all) to 7 (extremely). Adverse events represent side effects rated as 5 (a lot) or higher.
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
Responsible Party: Alexey Mukhin, Duke University
ClinicalTrials.gov Identifier: NCT01280968     History of Changes
Other Study ID Numbers: Pro00019787
First Submitted: November 16, 2010
First Posted: January 21, 2011
Results First Submitted: October 29, 2013
Results First Posted: December 18, 2013
Last Update Posted: March 5, 2014