NCT02097589

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Atorvastatin	10-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days.
DRUG	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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-03-27
• Last updated: 2015-09-28

Locations

1 site across 1 country: United States