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New treatment option for Healthy Young Adults
Official title Characterizing the Human Airway Immune Response to FluMist Vaccination
ClinicalTrials.gov ID: NCT07177417
What this study is testing
What is FluMist?
FluMist is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for healthy young adults.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to measure the immune response in the blood, nose, and lungs after participants receive either the FDA-approved inactivated influenza vaccine or the FDA-approved intranasal FluMist vaccine. The study will evaluate immune responses in groups of healthy, non-pregnant, volunteers between the ages of 18 and 40.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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 people 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...
See the full eligibility 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
- 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 people 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Allergy or contraindication to anesthesia for participants willing to have bronchoscopy done.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.