Systems Biological Assessment of Statin Effect on Vaccine Responses

NCT06024096 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: STUDY000062392025P010158
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaccine Response

Keywords

Flu Vaccine; Statins; Immunization Response; seasonal quadrivalent influenza vaccine; antibody (Ab) response

Outcome Measures

Primary Outcomes (1)

• Magnitude of the Antibody (Ab) Response to QIV in Statin Recipients and Non-recipients.

  Magnitude of neutralizing antibody responses against influenza vaccine strains at 29 days after vaccination among participants.

  Up to 29 days after vaccine administration

Secondary Outcomes (3)

• Number of Adverse Events (AEs) Grade 2 or Higher

  Until day 29 after vaccine administration

• Number of Adverse Events (AEs)

  Until day 29 after vaccine administration

• Number of Participants With Serious Adverse Events (SAEs)

  Up to 181 days after vaccine administration

Study Arms (2)

seasonal quadrivalent influenza vaccine (QIV)

ACTIVE COMPARATOR

Participants will receive the seasonal QIV

Biological: Quadrivalent seasonal influenza vaccine

statin therapy and a seasonal quadrivalent influenza vaccine (QIV)

ACTIVE COMPARATOR

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.

Drug: Atorvastatin; Biological: Quadrivalent seasonal influenza vaccine

Interventions

Quadrivalent seasonal influenza vaccine BIOLOGICAL

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.

Also known as: Flu vaccine

seasonal quadrivalent influenza vaccine (QIV); statin therapy and a seasonal quadrivalent influenza vaccine (QIV)

Atorvastatin DRUG

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.

Also known as: Statin Therapy

statin therapy and a seasonal quadrivalent influenza vaccine (QIV)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand and give informed consent.
• 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.

You may not qualify if:

• History of allergy or serious adverse reaction, including Guillain-Barré syndrome, to a vaccine or vaccine products.
• History of a medical condition resulting in impaired immunity such as active solid tumors, leukemia, lymphoma, use of immunosuppressive drugs, chemotherapy, or radiation therapy. Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
• History of HIV, Hepatitis B, or Hepatitis C infection.
• Chronic clinically significant medical problems that could be considered active or unstable (i.e. diagnosed within the past 3 months or requiring a change in medication within the past 3 months). This includes (but is not limited to):
• Insulin-dependent diabetes
• Severe heart disease (including arrhythmias)
• Severe lung disease
• Severe liver disease
• Severe kidney disease
• Severe hypertension: defined as life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit).
• BMI \> 30
• Current or previous use of statins or any other lipid-lowering drug.
• Pregnancy or breastfeeding or plans to become pregnant in the first 3 months of study participation.
• History of influenza infection within the same influenza season.
• Receipt of blood products or immune globulin products within the prior 3 months.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Hope Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Atorvastatin; Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Daniel S. Graciaa, MD, MPH, MSc
• Organization: Emory University

dsgraci@emory.edu

404-712-1370

Study Officials

• Daniel S. Graciaa, MD, MPH, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Varun Phadke, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Vin Tangpricha, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: September 20, 2023
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The team will share the data immediately following the study publication.
• Access Criteria: Data will be available via NCBI GEO

Locations

US (1)