FluMist versus injected flu shot: immune responses in the nose and lungs of young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a randomized trial, 30 healthy adults aged 18–40 will be assigned to receive either the FDA-approved intranasal FluMist or the standard injected inactivated influenza vaccine. Blood and nasopharyngeal swabs will be collected before vaccination and at days 3, 7, 14, 28, and 90 to measure antibody and cellular responses; up to 16 participants (8 per arm) may undergo optional bronchoscopies with bronchoalveolar lavage and endobronchial biopsy before vaccination and at days 14 and 90. The main outcome is the change in influenza vaccine-specific antibodies in the lower lungs and nose around 14 days after vaccination. Participants will be followed for about four months each within a two-year enrollment period at Washington University in St. Louis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Healthy adults aged 18-40 years
* Able to understand and give written informed consent
* In stable health, as determined by medical history and targeted physical exam related to the history

Exclusion Criteria:

* Prisoners
* Anyone unable to provide full written informed consent
* Pregnant women and nursing mothers or women who are planning to become pregnant during the study interval
* Female subjects who are sexually active with male partners who are not actively on hormonal contraception or who do not have an IUD in place
* Vaccination with a seasonal influenza vaccine or documented infection with seasonal influenza in the past 9 months
* Receipt of any vaccine in the 28 days prior to the pre-vaccination study visit or planned receipt of any non-study vaccine before completion of study day 28 visit
* Current smokers
* BMI \> 40
* Individuals with an immunocompromising medical condition or who have received systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to screening (for corticosteroids ≥ 10 mg/day of prednisone equivalent for \> 14 days total) or is anticipating the need for immunosuppressive treatment at any time during participation in the study
* Individuals who currently have symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator
* History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study
* Have donated blood, blood products, or bone marrow within 30 days before study entry, plan to donate blood at any time during the duration of study participation, or plan to donate blood within 30 days after the last blood draw.
* Current ongoing participation in a clinical trial evaluating an investigational agent unless the trial is in follow up only and the last dose of the investigational agent was taken \>30 days or \>5 half-lives prior to enrollment, whichever is greater.
* Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.

For participants willing to undergo bronchoscopy:

* Any known chronic pulmonary, cardiovascular, neurologic or hematologic disorder that could, in the opinion of the physician bronchoscopist or the principal investigator, put the subject at unnecessary risk from the sedation and bronchoscopy procedures. These conditions may include, but are not limited to, the following: asthma, COPD, obstructive sleep apnea, pulmonary fibrosis, cystic fibrosis, pulmonary hypertension, heart failure, previous myocardial infarction, hypertrophic cardiomyopathy, supraventricular tachycardia, paraplegia, quadriplegia, epilepsy, sickle cell disease, hemophilia, chronic anemia or active cancer.
* Coagulopathy (primary or iatrogenic) which would contraindicate bronchoscopy for participants willing to have those procedures done. Any participant with an INR\>1.4, PTT\>40 or platelet count \<100,000 at study screening will not be eligible for bronchoscopy.
* Evidence of significant pulmonary disease on the day of bronchoscopy, including pulse oximetry with oxygen saturation of 92% or less on room air, or infiltrate or pleural effusion on an upright PA and lateral chest x-ray performed on the day of bronchoscopy.
* Allergy or contraindication to anesthesia for participants willing to have bronchoscopy done.

Where it's running

• Washington University in Saint Louis School of Medicine Emergency Care and Research Core
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Philip A. Mudd, M.D., Ph.D. — Washington University in Saint Louis School of Medicine
• Study coordinator: Philip A. Mudd, M.D., Ph.D.
• Email: pmudd@wustl.edu
• Phone: 314-273-1576

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.