Clinical trial NCT06024096: Systems Biological Assessment of Statin Effect on Vaccine Responses
Official title: Systems Biological Assessment of Statin Effect on Vaccine Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccine Response
Keywords: Flu Vaccine
Statins
Immunization Response
seasonal quadrivalent influenza vaccine
antibody (Ab) response
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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):

  1. Insulin-dependent diabetes
  2. Severe heart disease (including arrhythmias)
  3. Severe lung disease
  4. Severe liver disease
  5. Severe kidney disease
  6. 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)

Primary outcomes:
measure: Magnitude of the antibody (Ab) response to QIV in statin recipients and non-recipients.
timeFrame: Up to 29 days after vaccine administration
Secondary outcomes:
measure: Frequency of adverse events (AEs)
timeFrame: Until day 29 after vaccine administration
measure: Severity of adverse events (AEs)
timeFrame: Until day 29 after vaccine administration
measure: Frequency of serious adverse events (SAEs)
timeFrame: Up to 181 days after vaccine administration
measure: Severity of serious adverse events
timeFrame: Up to 181 days after vaccine administration
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Hope Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Daniel S. Graciaa, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Nadine Rouphael, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Varun Phadke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Vin Tangpricha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: