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

NCT02097589 | Completed Phase 1 DMC

• 1 other identifier: IRB201400208
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Controls

Keywords

Health Controls

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Determine the effect of atorvastatin treatment on immunogenic cytokine levels following pneumococcal vaccination.

  approximately 49 days

Other Outcomes (1)

• Determine the effect of atorvastatin treatment on immune-regulatory gene expression.

  Approximately 49 days

Study Arms (2)

Pneumovax-Atorvastatin

EXPERIMENTAL

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; Drug: Pneumovax 23

Pneumovax-Placebo

PLACEBO COMPARATOR

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; Other: Placebo (lactose pill)

Interventions

Atorvastatin DRUG

10-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days.

Also known as: Lipitor

Pneumovax-Atorvastatin

Pneumovax 23 DRUG

Pneumovax 23 injected once, intramuscularly at Day 7.

Also known as: 23-valent pneumococcal polysaccharide vaccine

Pneumovax-Atorvastatin; Pneumovax-Placebo

Placebo (lactose pill) OTHER

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

Pneumovax-Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant, planning to become pregnant, breastfeeding
• 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
• Taking any immunosuppressive drugs including azathioprine, methotrexate, TNF inhibitors, cyclophosphamide, antimalarials, or sulfasalazine
• 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
• 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
• Latex allergy or previous allergic reaction or severe side effects from any vaccine
• 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
• BMI over 30, abnormal values on lipid panel or liver function test
• Failure to pass pre-study medical screening

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Clinical Translational Research Building

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• 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.

  PMID: 30686636 DERIVED

MeSH Terms

Interventions

Atorvastatin; 23-valent pneumococcal capsular polysaccharide vaccine; Lactose

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Mark L Brantly, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 27, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

US (1)