Systems Biological Assessment of Statin Effect on Vaccine Responses

PHASE4CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

September 20, 2023

Primary Completion Date

December 16, 2024

Study Completion Date

December 16, 2024

Conditions
Vaccine Response
Interventions
DRUG

Atorvastatin

"Atorvastatin is a lipid-lowering agent of the statin family that functions by blocking a rate-limiting enzyme, Hydroxymethylglutaryl-CoA (HMG-CoA) reductase, in lipid metabolism. This agent is commonly used for primary and secondary prevention of dyslipidemia. Participants will be asked to take Atorvastatin 80 mg daily at night, for 4 weeks prior to the vaccination, and continue the statin therapy for 4 weeks after vaccination.~The 80mg dose of atorvastatin allows for evaluation of the immunologic effects of statin medication with a short duration of therapy prior to vaccination."

BIOLOGICAL

Quadrivalent seasonal influenza vaccine

The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.

Trial Locations (1)

30322

Hope Clinic, Atlanta

All Listed Sponsors
lead

Emory University

OTHER

NCT06024096 - Systems Biological Assessment of Statin Effect on Vaccine Responses | Biotech Hunter | Biotech Hunter