Clinical trial NCT02097589: The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23
Official title: The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Controls
Keywords: Health Controls
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research study is to: Improve the effectiveness of vaccinations by identifying the effect of cholesterol medication, statins, on immune responses.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the effect of atorvastatin treatment on pneumococcal antigen specific antibody production.
timeFrame: approximately 49 days
Secondary outcomes:
measure: Determine the effect of atorvastatin treatment on immunogenic cytokine levels following pneumococcal vaccination.
timeFrame: approximately 49 days
Other outcomes:
measure: Determine the effect of atorvastatin treatment on immune-regulatory gene expression.
timeFrame: Approximately 49 days
Locations:
city: Gainesville
country: United States
facility: University of Florida Clinical Translational Research Building
state: Florida
Study officials:
affiliation: University of Florida
name: Mark L Brantly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wildes TJ, Grippin A, Fasanya H, Dyson KA, Brantly M. Effect of atorvastatin on humoral immune response to 23-valent pneumococcal polysaccharide vaccination in healthy volunteers: The StatVax randomized clinical trial. Vaccine. 2019 Feb 28;37(10):1313-1324. doi: 10.1016/j.vaccine.2019.01.023. Epub 2019 Jan 25.