Atorvastatin for Vaccine Response

Palo Alto (17 mi)

Overseen byDaniel S. Graciaa, MD, MPH, MSc

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Approved in 5 jurisdictions

Trial Summary

What is the purpose of this trial?This study is being done to answer the question: Does the use of statin lipid-lowering medication change the effect of influenza vaccine? The research team will use the knowledge gained from answering this question to understand how this medication affects long-lasting immune responses to vaccines. The researchers will study the immune response to the influenza vaccine in the blood (where antibodies are). The team will also look at how statin therapy affects the bacteria that live in the gut by collecting stool samples. To be in this research, participants must be adults willing to receive vaccines.

Eligibility Criteria

Adults aged 18-50 who can consent and agree to use birth control if of childbearing potential. Excluded are those with impaired immunity, serious chronic conditions, BMI over 30, current or past statin use, pregnancy/breastfeeding intentions within study period, recent vaccine receipt or infection.

Inclusion Criteria

I am between 18 and 50 years old.

Women of childbearing potential must agree to use effective birth control for the first 3 months of the study. A negative urine pregnancy test must be documented prior to vaccination

Exclusion Criteria

You are currently taking or have taken Statin

Treatment Details

The trial is investigating how Atorvastatin (a cholesterol-lowering drug) affects the immune response to a flu vaccine. It involves blood tests for antibodies and stool samples to study gut bacteria changes after vaccination.

2Treatment groups

Active Control

Group I: statin therapy and a seasonal quadrivalent influenza vaccine (QIV)Active Control2 Interventions

Participants randomized to the Statin + QIV arm will be asked to come back for an extra visit one month prior to the date of vaccination to start statin therapy.

Group II: seasonal quadrivalent influenza vaccine (QIV)Active Control1 Intervention

Participants will receive the seasonal QIV

Quadrivalent seasonal influenza vaccine is already approved in United States, Canada, European Union, Japan, Australia for the following indications:

🇺🇸 Approved in United States as Fluarix Quadrivalent for: