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

NCT ID: NCT02097589

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-09-30

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.

Conditions

Healthy Controls

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

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

Pneumovax 23

Intervention Type: DRUG

Pneumovax 23 injected once, intramuscularly at Day 7.

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.

Group Type: PLACEBO_COMPARATOR

Pneumovax 23

Intervention Type: DRUG

Pneumovax 23 injected once, intramuscularly at Day 7.

Placebo (lactose pill)

Intervention Type: OTHER

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

Interventions

Atorvastatin

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

Intervention Type: DRUG

Pneumovax 23

Pneumovax 23 injected once, intramuscularly at Day 7.

Intervention Type: DRUG

Placebo (lactose pill)

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

Intervention Type: OTHER

Other Intervention Names

Lipitor; 23-valent pneumococcal polysaccharide vaccine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark L Brantly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida Clinical Translational Research Building

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30686636 (View on PubMed)

Other Identifiers

IRB201400208

Identifier Type: -

Identifier Source: org_study_id