Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 2 Single Center, Open-label Study to Assess Immunogenicity and Safety of 6 Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®)in Smokers
Brief Summary: Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.


Options:
A: Inclusion Criteria:

* Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
* Written informed consent
* Negative urine pregnancy test, and willing to use birth control during the study, if applicable

Exclusion Criteria:

* Prior exposure to nicotine vaccine
* Clinically significant allergic reactions, especially to components of the vaccine
* Serious or unstable clinical disease within the past 6 months
* Use of any smoking cessation therapy within 30 days preceding 1st dose
* Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
* Use of any vaccine other than influenza vaccine within 30 days prior to each study dose
* Use of another IND drug or device within 30 days preceding 1st dose
* Inability to follow the protocol, or illicit drug use in the past 12 months, or psychiatric disorder in the past 3 months
B: Inclusion Criteria:

* Smokes at least 15 cigarettes per day
* Wants to quit smoking
* Good general health
* Negative pregnancy test prior to study entry
* Carbon monoxide level greater than 10 ppm

Exclusion Criteria:

* Prior exposure to NicVAX or any other nicotine vaccine
* Known allergic reaction to alum or any of the components of the vaccine
* Use of steroids, immunosuppressive agents or other medication that might interfere with an immune response
C: Inclusion Criteria:

* Written informed consent
* Age 18 to 70 years
* Smokers: \> 10 and ≤ 40 cigarettes per day and smoking history of more than 3 years
* Fageström Test for Nicotine Dependence (FTND) score ≥ 5
* Female participant must meet one of the following criteria: a) no reproductive potential due to menopause, hysterectomy, bilateral oophorectomy, or tubal ligation; b) agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 additional months after the last immunization

Exclusion Criteria:

* Pregnant or nursing
* History of severe allergy or immunological disorders
* Blood donation within previous 30 days
* Surgery within previous 30 days
* Use of investigational drugs within previous 60 days
* Significant cardiovascular disease:

  * angina pectoris
  * congestive heart failure
  * clinically significant murmurs
  * previous angioplasty or coronary artery bypass surgery
* Active infectious disease:

  * WBC \> 12 000 cells/µL
  * Seropositivity for Hepatitis B and C
  * History of risk behavior to acquire HIV
* Significant hepatic disease
* Significant renal disease
* Significant hematological disorder
* Significant pulmonary disease
* History of malignancy
* Autoimmune disease
* Organic neurological disorder or significant psychiatric disorder
* Use of psychoactive drug within one month before enrolment
* Abuse of drugs or alcohol
* Subjects using any concomitant medications due to chronic illness which bears a high risk of fluctuation in disease activity or exacerbations during a 12-months period such as coronary heart disease, asthma, severe COPD, chronic rheumatoid disease, diabetes, etc. should be excluded.
* Obesity: BMI \> 35 kg/m2
* Use of concomitant nicotine replacement treatment (NRT) at screening or visit 1
* Any planned surgical intervention during the study period
D: Inclusion Criteria:

* Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking.
* Smokers who are in good general health.

Exclusion Criteria:

* Prior exposure to NicVAX or any other nicotine vaccine.
* Use of systemic steroids.
* Cancer or cancer treatment in last 5 years.
* HIV infection.
* History of drug or alcohol abuse or dependence within 12 months.
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
* Inability to fulfill all visits for approximately 52 weeks.

Answer: A