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Table 1 Scheduled clinical procedures

From: The efficacy and safety of a nicotine conjugate vaccine (NicVAX®) or placebo co-administered with varenicline (Champix®) for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial

Visits

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

Study Week

-4 to -2

-2

-1

0

1

2

4

6

7

8

9

10

11

12

13

14

16

18

24

26

28

34

40

46

52/ET

Study Day

-28 to -14

-14

-7

0

7

14

28

42

49

56

63

70

77

84

91

98

112

126

168

182

196

238

280

322

364

Visit Window (Days)

 

±1

±1

±1

±2

±2

±2

±2

±2

±2

±2

±2

±2

±2

±2

±4

±4

±4

±4

±4

±5

±5

±5

±5

±5

Informed Consent

X

                        

Inclusion/Exclusion Criteria

X

                        

Medical History1

X

X

                       

Tobacco Use History1

X

X

                       

Randomize & Assign SID

 

X

                       

Physical Exam1

X

X

                      

X

Vital signs and weight2

X

X

 

X

X

X

X

X

 

X

 

X

 

X

 

X

 

X

X

 

X

X

X

X

X

Exhaled Carbon Monoxide

X

  

X

X

X

X

X

 

X

 

X

 

X

 

X

 

X

X

 

X

X

X

X

X

Anti-Nicotine Antibody

 

X

   

X

 

X

   

X

 

X

 

X

 

X

X

 

X

X

X

X

X

Laboratory tests: Hematology,

Chemistry

X

      

X

     

X

          

X

Urine Pregnancy Test

X3

X3

   

X

 

X

   

X

   

X

  

X

      

Urinalysis

X

      

X

     

X

          

X

QUIT DAY

    

X

                    

Quit Re-Challenge

             

X

  

X

  

X

     

Clinic Counseling

 

X

 

X

X

X

X

X

 

X

 

X

 

X

 

X

 

X

X

 

X

X

X

X

 

Telephone Counseling

  

X

     

X

 

X

 

X

 

X

 

X

  

X

     

NicVAX or Placebo

 

X

   

X

 

X

   

X

   

X

  

X

      

Varenicline

   

X

X

X

X

X

X

X

X

X

X

X

           

Nicotine Exposure Report Form4

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Minnesota Nicotine Withdrawal Questionnaire5

X

X

           

X

X

X

   

X

X

   

X

Reactogenicity Assessment6

 

X

   

X

 

X

   

X

   

X

  

X

      

Fagerström Test for Nicotine Dependence (FTND)

X

X

                

X

     

X

Adverse Events7

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Concomitant Medications8

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

  1. 1 Medical History, Physical Exam and Tobacco Use History must be performed prior to randomization.
  2. 2Vital signs include blood pressure, heart rate, respiration, temperature, and weight. Vital signs will be taken immediately before injection and 30 ±5 minutes post injection.
  3. 3A negative urine pregnancy test is required for all females of childbearing potential within 3 days prior to IP injection. Females who have menstruated in the past 12 months (even if irregularly) or are not surgically sterile are considered to be of childbearing potential.
  4. 4 The Nicotine Use Report Form will be completed weekly for entire study. Blank Nicotine Use Report Forms should be provided to the subject at each visit.
  5. 5The Minnesota Nicotine Withdrawal Questionnaire is completed weekly during weeks 12–15, weeks 26–29 and weeks 49–52.
  6. 6Reactogenicity will be collected for 7 days after each injection. Blank MNWS forms should be provided prior to each collection period.
  7. 7Adverse Events will be collected thru day 364.
  8. 8Concomitant medications will be collected thru day 364.
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