Smoking, Vaccines
Conditions
Keywords
Smoking cessation, vaccine, Phase 1
Brief summary
The purpose of this study is to determine the safety and tolerability of multiple doses of PF-05402536 and PF-06413367 in healthy adult smokers.
Interventions
BIOLOGICALNIC7-001
Intramuscular, multiple dose
BIOLOGICALNIC7-003
Intramuscular, multiple dose
BIOLOGICALSaline
Saline (0.9% sodium chloride)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Current cigarette smokers * Males or females of non-child bearing potential, who are between the minimum legal age for smoking (approximately 18 or 19 years, depending on local jurisdiction) and 55 years, inclusive, and who are motivated to stop smoking. * Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the prescreening assessment for entry, with no period of abstinence greater than 3 months in the past year.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, or neurologic disease that may compromise their ability to safely participate in the study. * Active suicidal ideation or history of suicidal behaviors within the past 5 years prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of solicited local reactions (erythema, induration, and pain) and severity of the local reactions as self-reported on electronic diaries (e-diaries) for 7 days following vaccination. | Within 7 days after dose |
| Frequency of solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and severity of solicited systemic events as self-reported on e-diaries for 7 days following vaccination. | Within 7 days after dose |
| Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment | Baseline up to Day 364 |
| Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment | Baseline up to Day 364 |
Secondary
| Measure | Time frame |
|---|---|
| Antibody titers against nicotine. | Up to Day 364 |
| smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges) | Up to Day 364 |
| Avidity of antibodies against nicotine. | Up to Day 364 |
| 7-day point prevalence of smoking abstinence | Up to Day 364 |
| 4-week continuous abstinence rate from smoking | Up to Day 364 |
Countries
Canada
Outcome results
None listed