DragonflyVaper: Please put a bug in this doctor's ear. It would be a tragedy if her vaccine were approved and we did not find out about potentially devastating effects until after it was approved and widely in use (think Chantix.)
Nicotine and nicotine derivatives are being studied as treatment of Attention Deficit Disorder, Alzheimer's, and several mood disorders (depression, anxiety, schizophrenia). It is suspected that a sizable percentage of smokers are--whether they realize it or not--keeping symptoms of these disorders under control with nicotine. This is called "self-medicating." The FDA-approved drugs for treatment of these problems often have very bad side effects, while the side effects for nicotine (if you get your nicotine without the smoke) are a temporary increase in heart rate and blood pressure.
The symptoms for nicotine withdrawal syndrome look remarkably like the DSM-IV diagnostic criteria for major depressive disorder. Supposedly these symptoms (if they appear at all) subside within a couple of weeks. But there are reports that these symptoms continue unabated indefinitely in a certain percentage of smokers (estimates range from 10% to 20%.)
Ask her if she would be willing to verify that taking the vaccine does not trigger permanent cognitive defects and/or mood disorders. This would not be a direct effect of the vaccine, but a secondary effect due to the fact that the beneficial effects of nicotine would be gone and blocked--perhaps forever. In other words, if the vaccine works well, it will be harmful to an unknown number of patients. If what I suspect will happen actually does happen, what I am going to suggest might help to identify the types of patients for whom the vaccine is contraindicated.
She would need to administer some standard tests to all subjects, and administer the same tests again a couple of weeks after the last dose of the vaccine is administered, and again at least 3 months later--even later if possible.
The tests might include:
The Test of Variables of Attention (T.O.V.A.®) is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder (ADHD). The T.O.V.A. is an objective, neurophysiological measure of attention, not a subjective rating of behavior. It is a 21.6 minute long, very simple "computer game" that measures your responses to either visual or auditory stimuli. These measurements are then compared to the measurements of a group of people without attention disorders who took the T.O.V.A.
A Continuous Performance Task/Test, or CPT, is a psychological test which measures a person's sustained and selective attention and impulsivity. Sustained attention is the ability to maintain a consistent focus on some continuous activity or stimuli, and is associated with impulsivity. Selective attention is the ability to focus on relevant stimuli and ignore competing stimuli. This skill is associated with distractibility.
The Stroop Task is a psychological test of our mental (attentional) vitality and flexibility. The task takes advantage of our ability to read words more quickly and automatically than we can name colors. If a word is printed or displayed in a color different from the color it actually names; for example, if the word "green" is written in blue ink (as shown in the figure to the left) we will say the word "green" more readily than we can name the color in which it is displayed, which in this case is "blue." The cognitive mechanism involved in this task is called directed attention, you have to manage your attention, inhibit or stop one response in order to say or do something else.
The minimental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is commonly used in medicine to screen for dementia. It is also used to estimate the severity of cognitive impairment at a given point in time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment.
The Minnesota Multiphasic Personality Inventory (MMPI) is one of the most frequently used personality tests in mental health. The test is used by trained professionals to assist in identifying personality structure and psychopathology. Actually, it's a take-home test, but it has over 500 questions so it takes hours to finish. For those interested in learning more about this one, here are some sample questions.
https://antipolygraph.org/cgi-bin/forums/YaBB.pl?num=1109032158
None of these tests is invasive. They are all performance tests. Conducting this testing in conjunction with administration of the vaccine would make her research invaluable.