Status:
COMPLETED
Systems Biological Assessment of Statin Effect on Vaccine Responses
Lead Sponsor:
Emory University
Conditions:
Vaccine Response
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
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...
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 sys...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06024096
Start Date
September 20 2023
End Date
December 16 2024
Last Update
January 7 2025
Active Locations (1)
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1
Hope Clinic
Atlanta, Georgia, United States, 30322