Atorvastatin for Vaccine Response
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you are currently using statins or any other lipid-lowering drugs. Also, if your medication interacts with statin therapy, you may not be eligible for the statin therapy group.
Is the quadrivalent influenza vaccine generally safe for humans?
How is the quadrivalent seasonal influenza vaccine different from other flu vaccines?
What data supports the effectiveness of the treatment Atorvastatin for Vaccine Response?
The research highlights the effectiveness of quadrivalent influenza vaccines (QIV) in preventing influenza, which is part of the treatment being studied. These vaccines are designed to protect against four different flu viruses, and studies show they are increasingly used in healthcare to prevent influenza.3791011
Who Is on the Research Team?
Nadine Rouphael, MD
Principal Investigator
Emory University
Varun Phadke, MD
Principal Investigator
Emory University
Vin Tangpricha, MD, PhD
Principal Investigator
Emory University
Daniel S. Graciaa, MD, MPH, MSc
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Statin Therapy Initiation
Participants randomized to the Statin + QIV arm will start statin therapy one month prior to vaccination
Vaccination
Participants receive the seasonal quadrivalent influenza vaccine (QIV)
Follow-up
Participants are monitored for safety and effectiveness after vaccination, including collection of blood and stool samples
Extended Follow-up
Participants are monitored for serious adverse events up to 181 days after vaccine administration
What Are the Treatments Tested in This Trial?
Interventions
- Atorvastatin
- Quadrivalent seasonal influenza vaccine
Quadrivalent seasonal influenza vaccine is already approved in United States, Canada, European Union, Japan for the following indications:
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Who Is Running the Clinical Trial?
Emory University
Lead Sponsor