Cholesterol drug may alter flu Shot's power
NCT ID NCT06024096
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether taking the statin drug atorvastatin changes the body's immune response to the flu vaccine. 63 adults took either a statin or a placebo for four weeks before and after getting the flu shot. Researchers measured antibody levels and checked for side effects, and also looked at gut bacteria from stool samples. The goal is to understand if common cholesterol medications can influence how well vaccines protect us.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Atorvastatin (a statin drug used to lower cholesterol)
- What this could lead to
- If it works, this could help doctors understand whether statins affect vaccine effectiveness, potentially guiding vaccination strategies for people on statins.
- What could go wrong
- This is a small, completed Phase 4 study with only 63 participants, so results may not apply to everyone. It looks at immune markers, not real-world infection rates, so the practical impact is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
63 people
The number who actually took part.
- Started
-
Sep 2023
- Finished
-
Dec 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Vaccine response are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hope Clinic
Atlanta, Georgia, 30322, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.