The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23

Due to the anti-inflammatory action of statins, it was proposed that statin treatment would
decrease the efficacy of vaccination. This response has yet to be explored following a
primary vaccination such as pneumococcal pneumonia. In this study, healthy volunteers will
be divided into 2 arms receiving treatment for 28 days: 40 mg atorvastatin or placebo.

Antibody titer for 23 serotypes, complete blood count (CBC), high-sensitivity c-reactive
protein (hsCRP), erythrocyte sedimentation rate (ESR), lipids, cytokines (TNF-alpha,
IFN-gamma, interleukins, etc.) and key membrane receptors (toll-like receptors, etc.) will
be measured for baseline before statin or placebo treatment. On day 7 of treatment,
pre-vaccination measures of the above parameters will be taken and an immune response will
be induced in all groups using Pneumovax 23 at Day 7. On days 8, 14, 21, and 28
post-vaccination measures will be compared to baseline and between groups.

Inclusion Criteria:

24 subjects are healthy volunteers between the ages of 21 and 40.

Exclusion Criteria:

1. Pregnant, planning to become pregnant, breastfeeding

2. Taking any of the following medications at time of study: antacids, antifungals,
antioxidants, colestipol, cyclosporine, digoxin, erythromycin, fibric acid
derivatives, niacin, oral contraceptives containing norethindrone or ethinyl
estradiol, statins, steroids

3. Taking any immunosuppressive drugs including azathioprine, methotrexate, TNF
inhibitors, cyclophosphamide, antimalarials, or sulfasalazine

4. Currently have or history of cardiovascular disease, diabetes, diphtheria, high blood
pressure, high cholesterol, immunodeficiencies, kidney disease, liver disease, low
blood pressure, muscular disease, seizure disorders, systemic lupus erythematosus or
other systemic autoimmune disorders

5. Not immunized in childhood against streptococcus pneumoniae; received pneumovax
vaccine within past year, or received 2 or more pneumovax boosters within the past 5
years

6. Latex allergy or previous allergic reaction or severe side effects from any vaccine

7. Heavy drinking (more than 15 drinks/week), illegal drug use within past six months,
unwillingness to abstain from alcohol, unwillingness to abstain from tobacco products
(dip, cigarettes, cigars, electronic cigarettes, etc.), illegal drugs, or grapefruit
juice for duration of study

8. BMI over 30, abnormal values on lipid panel or liver function test

9. Failure to pass pre-study medical screening