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

Healthy Controls Clinical Trial

— StatVax  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097589
• Other study ID #: IRB201400208
• Status: Completed
• Phase: Phase 1
• First received: March 24, 2014
• Last updated: September 25, 2015
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy Controls

Intervention

Drug:
• Atorvastatin
10-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days.
• Pneumovax 23
Pneumovax 23 injected once, intramuscularly at Day 7.

Other:
• Placebo (lactose pill)
10-person arm receiving treatment for 28 days: Placebo (lactose pill), taken orally, once daily for 28 days.

Locations

Country	Name	City	State
United States	University of Florida Clinical Translational Research Building	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine the effect of atorvastatin treatment on immune-regulatory gene expression.	The 24 subjects will be randomized into 2 groups of 12 individuals (6 per gender) and will be assigned to receive either atorvastatin treatment (40mg/day) or placebo (lactose pill) control.; Subjects will be asked to fast after midnight prior to any morning blood draws. On day 1 of treatment, blood will be drawn for a baseline. Treatment with either atorvastatin or placebo will begin on day one and will continue until day 28. Subjects will be instructed to take the study medication once a day at the same time each day.; On day seven of treatment, subjects will be immunized with Pneumovax 23, administered intramuscularly into the arm. Blood will be drawn at several time points following Pneumovax 23 administration. Measurements on blood will be made to determine the effect of statins on immune factor gene expression, serum protein levels, as well as at the cellular level.	Approximately 49 days	No
Primary	Determine the effect of atorvastatin treatment on pneumococcal antigen specific antibody production.	The 24 subjects will be randomized into 2 groups of 12 individuals (6 per gender) and will be assigned to receive either atorvastatin treatment (40mg/day) or placebo (lactose pill) control.; Subjects will be asked to fast after midnight prior to any morning blood draws. On day 1 of treatment, blood will be drawn for a baseline. Treatment with either atorvastatin or placebo will begin on day one and will continue until day 28. Subjects will be instructed to take the study medication once a day at the same time each day.; On day seven of treatment, subjects will be immunized with Pneumovax 23, administered intramuscularly into the arm. Blood will be drawn at several time points following Pneumovax 23 administration. Measurements on blood will be made to determine the effect of statins on immune factor gene expression, serum protein levels, as well as at the cellular level.	approximately 49 days	No
Secondary	Determine the effect of atorvastatin treatment on immunogenic cytokine levels following pneumococcal vaccination.	The 24 subjects will be randomized into 2 groups of 12 individuals (6 per gender) and will be assigned to receive either atorvastatin treatment (40mg/day) or placebo (lactose pill) control.; Subjects will be asked to fast after midnight prior to any morning blood draws. On day 1 of treatment, blood will be drawn for a baseline. Treatment with either atorvastatin or placebo will begin on day one and will continue until day 28. Subjects will be instructed to take the study medication once a day at the same time each day.; On day seven of treatment, subjects will be immunized with Pneumovax 23, administered intramuscularly into the arm. Blood will be drawn at several time points following Pneumovax 23 administration. Measurements on blood will be made to determine the effect of statins on immune factor gene expression, serum protein levels, as well as at the cellular level.	approximately 49 days	No