- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06024096
Systems Biological Assessment of Statin Effect on Vaccine Responses
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Daniel S. Graciaa, MD, MPH, MSc
- Phone Number: 404-712-9018 or 404-712-1370
- Email: dsgraci@emory.edu
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Recruiting
- Hope Clinic
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Contact:
- Daniel Graciaa, MD, MPH, MSc
- Phone Number: 404-712-9018
- Email: dsgraci@emory.edu
-
Principal Investigator:
- Daniel Graciaa, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: seasonal quadrivalent influenza vaccine (QIV)
Participants will receive the seasonal QIV
|
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.
Other Names:
|
Active Comparator: statin therapy and a seasonal quadrivalent influenza vaccine (QIV)
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.
|
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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Magnitude of the antibody (Ab) response to QIV in statin recipients and non-recipients.
Time Frame: Up to 29 days after vaccine administration
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Magnitude of neutralizing antibody responses against influenza vaccine strains at 29 days after vaccination among participants.
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Up to 29 days after vaccine administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of adverse events (AEs)
Time Frame: Until day 29 after vaccine administration
|
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.
|
Until day 29 after vaccine administration
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Severity of adverse events (AEs)
Time Frame: Until day 29 after vaccine administration
|
Adverse events (AE) will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0
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Until day 29 after vaccine administration
|
Frequency of serious adverse events (SAEs)
Time Frame: Up to 181 days after vaccine administration
|
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.
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Up to 181 days after vaccine administration
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Severity of serious adverse events
Time Frame: Up to 181 days after vaccine administration
|
SAE will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0.
|
Up to 181 days after vaccine administration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vin Tangpricha, MD, PhD, Emory University
- Principal Investigator: Nadine Rouphael, MD, Emory University
- Principal Investigator: Daniel S. Graciaa, MD, MPH, MSc, Emory University
- Principal Investigator: Varun Phadke, MD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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