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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
You are currently taking or have taken Statin
Timeline
Screening 1 day
Treatment 2 months
Follow Up 6 months
Awards & highlights
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 belowSelect...
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
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 moreTrial 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
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,686 Previous Clinical Trials
2,599,585 Total Patients Enrolled
Daniel S. Graciaa, MD, MPH, MScPrincipal InvestigatorEmory University
Nadine Rouphael, MDPrincipal InvestigatorEmory University
16 Previous Clinical Trials
843 Total Patients Enrolled
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