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Vaccine

Atorvastatin for Vaccine Response

Phase 4

Waitlist Available

Led By Daniel S. Graciaa, MD, MPH, MSc

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-50 years

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

Must not have

You are currently taking or have taken Statin

Timeline

Screening 1 day

Treatment 2 months

Follow Up 6 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is researching how statins affect the immune response to the influenza vaccine to understand how the drug affects long-term immunity. Participants must be adults willing to get vaccinated.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of statins like Atorvastatin include muscle pain, digestive problems, and increased liver enzymes. Flu vaccines may cause soreness at injection site, feverish feelings or muscle aches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 1 day1 visit

Treatment ~ 2 months2 visits

Follow Up ~ 6 months7 visits

Screening ~ 1 day

Treatment ~ 2 months

Follow Up ~6 months

This trial's timeline: 1 day for screening, 2 months for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Magnitude of the antibody (Ab) response to QIV in statin recipients and non-recipients.

Secondary study objectives

Frequency of adverse events (AEs)

Frequency of serious adverse events (SAEs)

Severity of adverse events (AEs)

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 4Eligibility criteria met