NCT06848309 · Washington University School of Medicine
Dissecting Human Immune Responses to Infection With Influenza or SARS-CoV-2
(WU 437)
What this study is about
The purpose of this study is to evaluate the virus-specific immune response in people who are symptomatic with confirmed influenza or COVID-19. We will study the immune response of people who have and who have not been vaccinated with the seasonal influenza and COVID-19 vaccines within the past year.
View original scientific description
The purpose of this study is to evaluate the virus-specific immune response in people who are symptomatic with confirmed influenza or COVID-19. We will study the immune response of people who have and who have not been vaccinated with the seasonal influenza and COVID-19 vaccines within the past year. All participants will have data collected and blood, saliva, and nasal swabs performed at five separate visits; 1) at study enrollment, 2) on study day 7, 3) on or between study days 10 to 28, 4) on study day 90, and 5) on study day 180. For participants who agree to the optional sub-study, bronchoscopy with bronchoalveolar lavage (BAL) and endobronchial biopsy (EBBx) will be performed once between study days 10 and 28 and once at study day 180. As part of the bronchoscopy procedure, two chest x-rays will be performed. The bronchoscopy and chest x-ray procedures are not required for participation in the study.
Interventions
PROCEDURE
Bronchoscopy
Some participants in all 5 groups may undergo an optional bronchoscopy procedure with bronchoalveolar lavage and endobronchial biopsy collection if they choose.
Primary outcome measures
To measure the difference in the concentration of systemic and mucosal influenza-specific or SARS-CoV-2-specific IgG and IgA in the blood, saliva, nasopharynx, and lower airways and how these concentrations change over time following acute infection
Time frame: At study enrollment (day 0) which will occur during active symptomatic viral infection and at 6 months after study enrollment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must have presented with acute, symptomatic seasonal influenza or SARS-CoV-2 infection proven by an approved CLIA certified test and be enrolled in study while still symptomatic or within 72 hours of the resolution of viral respiratory illness symptoms.
- Alternatively, uninfected participants in the control cohort must have received an FDA-approved seasonal influenza and/or SARS-CoV-2 vaccine within the past 12 months and not experienced a documented influenza or SARS-CoV-2 infection since receiving that most recent vaccine dose.
- Participants must be able to understand and provide full written informed consent.
- Participants must be male or female between the ages of 18 and 60.
- Participants must be in stable health, as determined by medical history and targeted physical exam related to that history.
Exclusion criteria
- Co-infection with any respiratory virus in addition to the index influenza or SARS-CoV-2 infection on a multi-plex viral testing panel.
- Severe illness with anticipated need for hospitalization for the index infection.
- Current or previous diagnosis of an immunocompromising condition.
- Receipt of systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to screening or is anticipating the need for immunosuppressive treatment at any time during study participation.
- Current 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. Any known diagnosed chronic pulmonary, cardiovascular, renal, hepatic, hematologic, or metabolic disorder with the exception of isolated treated hypertension.
- Known chronic neurologic or neurodevelopmental condition including spinal cord injury with resultant weakness of any kind (this does not exclude patients with chronic back pain or previous disk herniation/back surgery, only patients with documented weakness, quadriplegia or paraplegia). This exclusion criterion does not exclude from the study individuals with recurrent migraine headaches as their only chronic neurologic condition.
- Active cancer diagnosis, including any cancer that has not been in remission for at least 1 year. Isolated basal or squamous cell skin cancers are not excluded.
- 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.
- Body Mass Index (BMI) \> 40
- Pregnant women and nursing mothers or women who are planning to become pregnant during the study interval.
- Have donated blood, blood products or bone marrow within 30 days before study entry or plan to donate blood at any time during the duration of study participation or up to 30 days after the last study 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 safe and proper conduct of the study. For participants willing to undergo bronchoscopy:
- Coagulopathy as defined by screening safety labs that reveal an INR \> 1.4, at PTT \> 40, or a platelet count \< 100,000 precludes participation in the bronchoscopy procedure.
- Evidence of ongoing 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 noted on an upright PA and lateral chest x-ray performed on the day of bronchoscopy.
- Allergy or contraindication to anesthesia for participants willing to undergo bronchoscopy.
Where
- St Louis, Missouri
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2026 · Source of record for eligibility and locations