MedDataX Logo

Trial Outcomes & Findings for Nicotine Vaccination and Nicotinic Receptor Occupancy (NCT NCT00996034)

NCT ID: NCT00996034

Last Updated: 2015-12-24

Results Overview

nAchR levels from baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

3 months

Results posted on

2015-12-24

Participant Flow

Enrollment in to the study ended in Feb. 2011. Subjects were screened and recruited from the VA West Haven, CT.

Several possible subject were not enrolled in to the study because of the exclusion/inclusion criteria, such as allergies to medications, high blood pressure, or SCID II diagnosis

Participant milestones

Participant milestones
Measure
Healthy Smoker
Healthy smokers with nicotine dependence Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days \[123I\]5-IA-85380 : up to 10 mCi of \[123I\]5-IA-85380, I.V. on each of two SPECT Scan days NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies
Overall Study
STARTED
14
Overall Study
COMPLETED
11
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Healthy Smoker
Healthy smokers with nicotine dependence Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days \[123I\]5-IA-85380 : up to 10 mCi of \[123I\]5-IA-85380, I.V. on each of two SPECT Scan days NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies
Overall Study
Lost to Follow-up
2
Overall Study
withdrawn by PI
1

Baseline Characteristics

Nicotine Vaccination and Nicotinic Receptor Occupancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Healthy Smoker
n=14 Participants
Healthy smokers with nicotine dependence Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days \[123I\]5-IA-85380 : up to 10 mCi of \[123I\]5-IA-85380, I.V. on each of two SPECT Scan days NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
31.15 years
STANDARD_DEVIATION 8.33 • n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
Region of Enrollment
United States
14 participants
n=5 Participants

PRIMARY outcome

Timeframe: 3 months

nAchR levels from baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2.

Outcome measures

Outcome measures
Measure
Healthy Smoker
n=11 Participants
Healthy smokers with nicotine dependence Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days \[123I\]5-IA-85380 : up to 10 mCi of \[123I\]5-IA-85380, I.V. on each of two SPECT Scan days NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies
Mean of the Average Nicotine Binding % at Scan 1 and Scan 2
Scan 1
54.9 percentage of average nicotine binding
Standard Deviation 8.7
Mean of the Average Nicotine Binding % at Scan 1 and Scan 2
Scan 2
49.1 percentage of average nicotine binding
Standard Deviation 10.1

Adverse Events

Healthy Smoker

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Irina Esterlis, Ph.D.

Yale University

Phone: 203-932-5711

Results disclosure agreements

  • Principal investigator is a sponsor employee The sponsor has 30 days to approve anything that PI would like to publish and/or present
  • Publication restrictions are in place

Restriction type: OTHER