60 Participants Needed

Atorvastatin for Vaccine Response

DS
Overseen ByDaniel S. Graciaa, MD, MPH, MSc
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Trial Phase: Phase 4
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are currently using statins or any other lipid-lowering drugs. Also, if your medication interacts with statin therapy, you may not be eligible for the statin therapy group.

What data supports the effectiveness of the treatment Atorvastatin for Vaccine Response?

The research highlights the effectiveness of quadrivalent influenza vaccines (QIV) in preventing influenza, which is part of the treatment being studied. These vaccines are designed to protect against four different flu viruses, and studies show they are increasingly used in healthcare to prevent influenza.12345

Is the quadrivalent influenza vaccine generally safe for humans?

The quadrivalent influenza vaccine (QIV) is generally safe for humans, with most reported side effects being mild, such as injection site reactions, fever, headache, and nausea. Serious side effects are rare, and no new safety concerns have been identified in recent studies.36789

How is the quadrivalent seasonal influenza vaccine different from other flu vaccines?

The quadrivalent seasonal influenza vaccine (QIV) is unique because it includes two A strains and two B lineages, which helps prevent a mismatch with circulating flu strains, unlike the trivalent vaccine that only covers one B lineage.3481011

Research Team

NR

Nadine Rouphael, MD

Principal Investigator

Emory University

VP

Varun Phadke, MD

Principal Investigator

Emory University

VT

Vin Tangpricha, MD, PhD

Principal Investigator

Emory University

DS

Daniel S. Graciaa, MD, MPH, MSc

Principal Investigator

Emory University

Eligibility Criteria

Adults aged 18-50 who can consent and agree to use birth control if of childbearing potential. Excluded are those with impaired immunity, serious chronic conditions, BMI over 30, current or past statin use, pregnancy/breastfeeding intentions within study period, recent vaccine receipt or infection.

Inclusion Criteria

I understand the study and agree to participate.
I am between 18 and 50 years old.
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

You are currently taking or have taken Statin
I do not have severe health issues or recent major medical changes.
You are currently taking or have taken Statin
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Statin Therapy Initiation

Participants randomized to the Statin + QIV arm will start statin therapy one month prior to vaccination

4 weeks
1 visit (in-person)

Vaccination

Participants receive the seasonal quadrivalent influenza vaccine (QIV)

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination, including collection of blood and stool samples

29 days
Multiple visits (in-person)

Extended Follow-up

Participants are monitored for serious adverse events up to 181 days after vaccine administration

152 days

Treatment Details

Interventions

  • Atorvastatin
  • Quadrivalent seasonal influenza vaccine
Trial OverviewThe trial is investigating how Atorvastatin (a cholesterol-lowering drug) affects the immune response to a flu vaccine. It involves blood tests for antibodies and stool samples to study gut bacteria changes after vaccination.
Participant Groups
2Treatment groups
Active Control
Group I: statin therapy and a seasonal quadrivalent influenza vaccine (QIV)Active Control2 Interventions
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.
Group II: seasonal quadrivalent influenza vaccine (QIV)Active Control1 Intervention
Participants will receive the seasonal QIV

Quadrivalent seasonal influenza vaccine is already approved in United States, Canada, European Union, Japan for the following indications:

🇺🇸
Approved in United States as Fluarix Quadrivalent for:
  • Prevention of influenza A and B in individuals 6 months of age and older
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Approved in Canada as Flulaval Quadrivalent for:
  • Prevention of influenza A and B in individuals 6 months of age and older
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Approved in European Union as Fluzone Quadrivalent for:
  • Prevention of influenza A and B in individuals 6 months of age and older
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Approved in Japan as Quadrivalent seasonal influenza vaccine for:
  • Prevention of influenza A and B in individuals 6 months of age and older

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Findings from Research

The high-dose inactivated influenza vaccine quadrivalent (HD-IIV4) has been shown to be safe and effective in preventing influenza in adults aged 65 and older, with improved immunogenicity against additional B strains compared to standard vaccines.
Despite some increased adverse reactions like injection-site pain and myalgia, HD-IIV4 is recommended as the vaccine of choice for older adults due to its superior efficacy compared to other influenza vaccines.
High-Dose Inactivated Influenza Vaccine Quadrivalent for Older Adults.Chahine, EB.[2021]
The quadrivalent influenza vaccine (QIV) demonstrated similar efficacy to the trivalent influenza vaccine (TIV) for the three common strains, but showed superior immunogenicity for the additional B lineages not included in TIV, with significant increases in seroprotection and seroconversion rates.
Both QIV and TIV had comparable safety profiles, with no serious adverse events reported; however, QIV was associated with a slightly higher incidence of injection-site pain.
Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials.Moa, AM., Chughtai, AA., Muscatello, DJ., et al.[2018]
The Fluzone Intradermal (ID) vaccine was found to be as immunogenic as the standard intramuscular (IM) vaccine, showing no significant differences in antibody responses for all three viral strains tested.
While the ID vaccine had higher rates of local reactions like erythema and swelling compared to the IM vaccine, it was well-tolerated overall, with no serious adverse events reported, indicating it can be safely used for annual revaccination in adults.
Safety and immunogenicity of revaccination with reduced dose intradermal and standard dose intramuscular influenza vaccines in adults 18-64 years of age.Gorse, GJ., Falsey, AR., Johnson, CM., et al.[2013]

References

Immunogenicity and Safety of the Quadrivalent Adjuvant Subunit Influenza Vaccine in Seropositive and Seronegative Healthy People and Patients with Common Variable Immunodeficiency. [2023]
Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Seasonal Influenza Vaccine in Young Children at High Risk of Influenza-associated Complications: A Phase III, Randomized, Observer-blind, Multicenter Clinical Trial. [2022]
High-Dose Inactivated Influenza Vaccine Quadrivalent for Older Adults. [2021]
Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. [2018]
Safety and immunogenicity of revaccination with reduced dose intradermal and standard dose intramuscular influenza vaccines in adults 18-64 years of age. [2013]
Postmarketing safety surveillance of high-dose quadrivalent influenza vaccine: Reports to the Vaccine Adverse Event Reporting System. [2022]
Improved post-marketing safety surveillance of quadrivalent inactivated influenza vaccine in Mexico using a computerized, SMS-based follow-up system. [2022]
Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years. [2018]
Three seasons of enhanced safety surveillance of a cell culture-based quadrivalent influenza vaccine. [2023]
Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6-59 months of age: A phase 3, randomized, noninferiority study. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
From trivalent to quadrivalent influenza vaccines: Public health and economic burden for different immunization strategies in Spain. [2020]