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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02097589
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Healthy Controls Drug: Atorvastatin Drug: Pneumovax 23 Other: Placebo (lactose pill) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014


Arm Intervention/treatment
Experimental: Pneumovax-Atorvastatin
10-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days. Pneumovax 23 injected once, intramuscularly at Day 7.
Drug: Atorvastatin
10-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days.
Other Name: Lipitor

Drug: Pneumovax 23
Pneumovax 23 injected once, intramuscularly at Day 7.
Other Name: 23-valent pneumococcal polysaccharide vaccine

Placebo Comparator: Pneumovax-Placebo
10-person arm receiving treatment for 28 days: Placebo (lactose pill), taken orally, once daily for 28 days. Pneumovax 23 injected once, intramuscularly at Day 7.
Drug: Pneumovax 23
Pneumovax 23 injected once, intramuscularly at Day 7.
Other Name: 23-valent pneumococcal polysaccharide vaccine

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




Primary Outcome Measures :
  1. Determine the effect of atorvastatin treatment on pneumococcal antigen specific antibody production. [ Time Frame: approximately 49 days ]

    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.



Secondary Outcome Measures :
  1. Determine the effect of atorvastatin treatment on immunogenic cytokine levels following pneumococcal vaccination. [ Time Frame: approximately 49 days ]

    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.



Other Outcome Measures:
  1. Determine the effect of atorvastatin treatment on immune-regulatory gene expression. [ Time Frame: Approximately 49 days ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097589


Locations
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United States, Florida
University of Florida Clinical Translational Research Building
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Mark L Brantly, MD University of Florida
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02097589    
Other Study ID Numbers: IRB201400208
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015
Keywords provided by University of Florida:
Health Controls
Additional relevant MeSH terms:
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Atorvastatin
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors