Trial Outcomes & Findings for Improving the Efficacy of Anti-Nicotine Immunotherapy (NCT NCT01280968)
NCT ID: NCT01280968
Last Updated: 2014-03-05
Results Overview
There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
measured at week 1 and week 16
Results posted on
2014-03-05
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
7
|
|
Overall Study
COMPLETED
|
27
|
4
|
|
Overall Study
NOT COMPLETED
|
18
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
2
|
|
Overall Study
Unable to Follow Experimental Protocol
|
2
|
0
|
|
Overall Study
Commuting Problems
|
2
|
0
|
|
Overall Study
Anxiety
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Scheduling Conflicts
|
1
|
1
|
|
Overall Study
Pre-existing Neurological Condition
|
1
|
0
|
|
Overall Study
Unable to Smoke in Supine Position
|
1
|
0
|
Baseline Characteristics
Improving the Efficacy of Anti-Nicotine Immunotherapy
Baseline characteristics by cohort
| Measure |
NIC002 Vaccine in Aluminum Hydroxide
n=45 Participants
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
n=7 Participants
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
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
43 years
n=5 Participants
|
44 years
n=7 Participants
|
43 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
7 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Cigarettes Per Day
|
19 cigarettes per day
n=5 Participants
|
21 cigarettes per day
n=7 Participants
|
19 cigarettes per day
n=5 Participants
|
|
Pack-Years
|
22 pack-years
n=5 Participants
|
25 pack-years
n=7 Participants
|
22 pack-years
n=5 Participants
|
PRIMARY outcome
Timeframe: measured at week 1 and week 16There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
Outcome measures
| Measure |
NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects
n=29 Participants
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.
|
NIC002, Tertile With Highest Antibody Binding Capacity
n=10 Participants
|
Placebo Vaccine - Aluminum Hydroxide
n=4 Participants
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.
|
|---|---|---|---|
|
Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs
single cigarette puff
|
1 percentage of change
Standard Error 5
|
-15 percentage of change
Standard Error 7
|
-0.2 percentage of change
Standard Error 7.1
|
|
Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs
multiple cigarette puffs
|
0.1 percentage of change
Standard Error 5.7
|
-9 percentage of change
Standard Error 8
|
-1.1 percentage of change
Standard Error 9.6
|
PRIMARY outcome
Timeframe: measured at week 1 and week 16There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
Outcome measures
| Measure |
NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects
n=29 Participants
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.
|
NIC002, Tertile With Highest Antibody Binding Capacity
n=10 Participants
|
Placebo Vaccine - Aluminum Hydroxide
n=4 Participants
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.
|
|---|---|---|---|
|
Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs
single cigarette puff
|
1 percentage of change
Standard Error 4
|
-15 percentage of change
Standard Error 6
|
0 percentage of change
Standard Error 7.8
|
|
Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs
multiple cigarette puffs
|
-0.7 percentage of change
Standard Error 5.1
|
-6 percentage of change
Standard Error 9
|
-1.3 percentage of change
Standard Error 9.8
|
PRIMARY outcome
Timeframe: measured at week 1 and week 16There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
Outcome measures
| Measure |
NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects
n=29 Participants
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.
|
NIC002, Tertile With Highest Antibody Binding Capacity
n=10 Participants
|
Placebo Vaccine - Aluminum Hydroxide
n=4 Participants
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.
|
|---|---|---|---|
|
Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs
multiple cigarette puffs
|
-2 percentage of change
Standard Error 4
|
0 percentage of change
Standard Error 7
|
3.8 percentage of change
Standard Error 11.6
|
|
Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs
single cigarette puff
|
0 percentage of change
Standard Error 11
|
15 percentage of change
Standard Error 30
|
-4.4 percentage of change
Standard Error 9.6
|
PRIMARY outcome
Timeframe: measured at week 1 and week 16Outcome measures
| Measure |
NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects
n=29 Participants
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.
|
NIC002, Tertile With Highest Antibody Binding Capacity
n=10 Participants
|
Placebo Vaccine - Aluminum Hydroxide
n=4 Participants
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.
|
|---|---|---|---|
|
Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff
|
22.5 percentage of change
Standard Error 12.7
|
9 percentage of change
Standard Error 30
|
2.4 percentage of change
Standard Error 5.9
|
Adverse Events
NIC002 Vaccine in Aluminum Hydroxide
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo Vaccine - Aluminum Hydroxide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NIC002 Vaccine in Aluminum Hydroxide
n=36 participants at risk
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
n=5 participants at risk
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.
|
|---|---|---|
|
General disorders
Headache
|
8.3%
3/36 • Number of events 8
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.
|
20.0%
1/5 • Number of events 1
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.
|
|
General disorders
Weight Changes
|
2.8%
1/36 • Number of events 2
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.
|
20.0%
1/5 • Number of events 1
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.
|
|
General disorders
Back Pain
|
5.6%
2/36 • Number of events 2
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.
|
0.00%
0/5
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.
|
|
General disorders
Feeling Cold
|
8.3%
3/36 • Number of events 9
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.
|
0.00%
0/5
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.
|
|
General disorders
Feeling Hot
|
11.1%
4/36 • Number of events 5
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.
|
0.00%
0/5
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.
|
|
General disorders
Nasal Congestion
|
0.00%
0/36
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.
|
20.0%
1/5 • Number of events 1
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.
|
|
General disorders
Runny Nose
|
0.00%
0/36
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.
|
20.0%
1/5 • Number of events 1
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.
|
|
General disorders
Sore Throat
|
5.6%
2/36 • Number of events 2
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.
|
0.00%
0/5
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.
|
|
General disorders
Fatigue
|
11.1%
4/36 • Number of events 11
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.
|
20.0%
1/5 • Number of events 1
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.
|
|
General disorders
Tenderness at Injection Site
|
5.6%
2/36 • Number of events 2
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.
|
0.00%
0/5
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.
|
Additional Information
Alexey G Mukhin, M.D., Ph.D.
Duke University Medical Center
Phone: Telephone: 919-668-5055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place