Vaccine ResponsePhase 4NCT06024096
Systems Biological Assessment of Statin Effect on Vaccine Responses
A Phase 4 study testing Atorvastatin and Quadrivalent seasonal influenza vaccine in people with Vaccine Response, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Response
- What is being tested?
- Atorvastatin and Quadrivalent seasonal influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 16 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
- History of excessive alcohol consumption, drug use, psychiatric conditions, social conditions, or occupational conditions that in the opinion of the investigator would preclude compliance with the trial.
- Receipt of any live vaccines 30 days before or plans to receive any live vaccines 30 days after vaccination.
- Receipt of any inactivated vaccines 14 days before or plans to receive any inactivated vaccines 14 days after vaccination.
- For participants randomized to the statin therapy + QIV group:
- The participant is currently taking any medication that has known interactions with statin therapy.
- History of renal or hepatic impairment.
- Abnormal Safety lab results >1.5 upper limit normal (ULN)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Statins are widely used for their lipid-lowering and cardiovascular protective effects. Additional research has shown that statins can be anti-inflammatory and play a part in modulating the immune system. These effects are called into action in events such as pneumonia, influenza infection, and sepsis. This study will include a screening visit, a statin therapy initiation visit (if the participant is in the statin therapy group), a vaccination visit, and a series of follow-up visits. The statin medication will be dispensed by the study staff with clear instructions on how to take the medication for two months (one month prior to vaccination, and one month after vaccination). Other study procedures include a collection of medical history and medications taken, a urine pregnancy test for participants who are biologically able to become pregnant, a recording of vital signs, and a collection of any adverse events that the participant experiences during their participation in the study. The stool will be collected in one screening visit, at the vaccination visit, and one follow-up visit. Safety tests to evaluate muscle health and liver function will be obtained as well at screening and for participants selected to receive the statin therapy, at two follow-up visits. Memory Aid will be completed by the participant after vaccination.
The blood and stool samples collected during this study will be stored and tested to evaluate how the immune system responds to statin therapy and vaccination over time. The remaining unused samples will be stored for use in future research.
This research will help advance the knowledge that researchers have on how the immune system reacts to a vaccine if previously exposed to a statin therapy regimen. This will, in turn, enable us to identify the factors that help predict the extent of durability of protection gained from a specific vaccine. This may impact the way future vaccines are developed to provide long-lasting immunity against infections.
- Conditions
- Vaccine Response
- Being tested
- Atorvastatin, Quadrivalent seasonal influenza vaccine
- Keywords
- Flu Vaccine, Statins, Immunization Response, seasonal quadrivalent influenza vaccine, antibody (Ab) response
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Statin Therapy
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.
Quadrivalent seasonal influenza vaccineBiological
Also called Flu 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.
| Study group | Role | What they receive |
|---|---|---|
| seasonal quadrivalent influenza vaccine (QIV) | Active comparator | Participants will receive the seasonal QIV Receives: 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. Receives: Drug: Atorvastatin; Biological: Quadrivalent seasonal influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 29 days after vaccine administration
Secondary outcomes (3)
Number of Adverse Events (AEs) Grade 2 or Higher
Adverse events of grade 2 or higher (AE, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the vaccine, without any judgment about causality) will be identified during questioning or examination of participants during study visits or receiving a safety contact from a participant.
Measured: Until day 29 after vaccine administration
Number of Adverse Events (AEs)
Adverse events (AE) will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0
Measured: Until day 29 after vaccine administration
Number of Participants With Serious Adverse Events (SAEs)
Serious adverse events (SAE, defined as an AE that in the view of the investigator results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect) will be identified during questioning or examination of participants during study visits or receiving a safety contact from a participant any time during the study.
Measured: Up to 181 days after vaccine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start20 Sep 2023
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaccine ResponseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel S. Graciaa, MD, Emory University
- Investigators
- Daniel S. Graciaa, MD, MPH, MSc, Principal investigator, Emory UniversityNadine Rouphael, MD, Principal investigator, Emory UniversityVarun Phadke, MD, Principal investigator, Emory UniversityVin Tangpricha, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024096
- Sponsor's protocol ID
- STUDY00006239
- Other IDs
- 2025P010158
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2023
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share de-identified participant data (including data dictionaries) and Transcriptomics data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biological Assessment of Statin Effect on Vaccine Responses
- ClinicalTrials.gov ID
- NCT06024096
- Acronym / sponsor ID
- STUDY00006239
- Conditions
- Vaccine Response
- Keywords
- Flu Vaccine, Statins, Immunization Response, seasonal quadrivalent influenza vaccine, antibody (Ab) response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Statins are widely used for their lipid-lowering and cardiovascular protective effects. Additional research has shown that statins can be anti-inflammatory and play a part in modulating the immune system. These effects are called into action in events such as pneumonia, influenza infection, and sepsis. This study will include a screening visit, a statin therapy initiation visit (if the participant is in the statin therapy group), a vaccination visit, and a series of follow-up visits. The statin medication will be dispensed by the study staff with clear instructions on how to take the medication for two months (one month prior to vaccination, and one month after vaccination). Other study procedures include a collection of medical history and medications taken, a urine pregnancy test for participants who are biologically able to become pregnant, a recording of vital signs, and a collection of any adverse events that the participant experiences during their participation in the study. The stool will be collected in one screening visit, at the vaccination visit, and one follow-up visit. Safety tests to evaluate muscle health and liver function will be obtained as well at screening and for participants selected to receive the statin therapy, at two follow-up visits. Memory Aid will be completed by the participant after vaccination.
The blood and stool samples collected during this study will be stored and tested to evaluate how the immune system responds to statin therapy and vaccination over time. The remaining unused samples will be stored for use in future research.
This research will help advance the knowledge that researchers have on how the immune system reacts to a vaccine if previously exposed to a statin therapy regimen. This will, in turn, enable us to identify the factors that help predict the extent of durability of protection gained from a specific vaccine. This may impact the way future vaccines are developed to provide long-lasting immunity against infections.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| seasonal quadrivalent influenza vaccine (QIV) | Active comparator | Biological: Quadrivalent seasonal influenza vaccineParticipants will receive the seasonal QIV |
| statin therapy and a seasonal quadrivalent influenza vaccine (QIV) | Active comparator | Drug: Atorvastatin, Biological: Quadrivalent seasonal influenza vaccineParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (22 listed)
- 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):
- BMI > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Statin TherapyAtorvastatin 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. | Drug | statin therapy and a seasonal quadrivalent influenza vaccine (QIV) |
| Quadrivalent seasonal influenza vaccineAlso: Flu vaccineThe 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. | Biological | seasonal quadrivalent influenza vaccine (QIV), statin therapy and a seasonal quadrivalent influenza vaccine (QIV) |
Primary outcome
Magnitude of the Antibody (Ab) Response to QIV in Statin Recipients and Non-recipients.
Time frame: Up to 29 days after vaccine administration
Magnitude of neutralizing antibody responses against influenza vaccine strains at 29 days after vaccination among participants.
3 secondary outcomes
Number of Adverse Events (AEs) Grade 2 or Higher
Time frame: Until day 29 after vaccine administration
Number of Adverse Events (AEs)
Time frame: Until day 29 after vaccine administration
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 181 days after vaccine administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The research team will share de-identified participant data (including data dictionaries) and Transcriptomics data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel S. Graciaa, MD, MPH, MSc principal investigator
Emory University
Nadine Rouphael, MD principal investigator
Emory University
Varun Phadke, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin and Quadrivalent seasonal influenza vaccine in people with Vaccine Response, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of the Antibody (Ab) Response to QIV in Statin Recipients and Non-recipients. (time frame: Up to 29 days after vaccine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.