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Vaccine

Atorvastatin for Vaccine Response

Phase 4
Recruiting
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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Magnitude of the antibody (Ab) response to QIV in statin recipients and non-recipients.
Secondary outcome measures
Frequency of adverse events (AEs)
Frequency of serious adverse events (SAEs)
Severity of adverse events (AEs)
+1 more

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

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
1,640 Previous Clinical Trials
2,560,597 Total Patients Enrolled
Daniel S. Graciaa, MD, MPH, MScPrincipal InvestigatorEmory University
Nadine Rouphael, MDPrincipal InvestigatorEmory University
16 Previous Clinical Trials
843 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I satisfy the criteria to join this research project?

"Potential participants should demonstrate a vaccine response and be in the 18 - 50 age range to qualify for this clinical trial. 60 individuals are slated to be accepted into the study."

Answered by AI

Is the age prerequisite for this trial limited to those under 40 years of age?

"According to the prerequisites for participation in this study, applicants cannot be younger than 18 or older than 50."

Answered by AI

Is the seasonal quadrivalent influenza vaccine (QIV) safe for human consumption?

"Seasonal quadrivalent influenza vaccine (QIV) is given a score of 3 due to the fact that its approval has reached Phase 4, demonstrating sufficient evidence for safety and efficacy."

Answered by AI

Is this experiment still open to recruitment?

"This trial, which was posted on September 11th 2023 and last modified in August of the same year is no longer looking for participants. However, 5 other medical experiments are currently enrolling patients at this stage."

Answered by AI

Who else is applying?

What site did they apply to?
Hope Clinic
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Hope Clinic: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Systems Biological Assessment of Statin Effect on Vaccine Responses
Daniel S. Graciaa, MD 2023. "Systems Biological Assessment of Statin Effect on Vaccine Responses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06024096.
All > Lipitor
~40 spots leftby Mar 2026
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