Dissecting Human Immune Responses to Infection With Influenza or SARS-CoV-2

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06848309
Status
Recruiting
Apply to this trial

Conditions

  • Immune Response of Host
  • Influenza
  • SARS-CoV-2 (COVID-19) Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Bronchoscopy — PROCEDURE
    Some participants in all 5 groups may undergo an optional bronchoscopy procedure with bronchoalveolar lavage and endobronchial biopsy collection if they choose.

Study Details

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.

Key Dates

Start date
Mar 7, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Uninfected Cohort
    Subjects that 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 the vaccine dose.
  • Arm: Seasonal Influenza Infected, Not Recently Vaccinated Cohort
    CLIA-approved influenza test positive in participants with an acute illness and active symptoms of a respiratory viral infection that triggered the clinical testing. Participants in this group have not received a seasonal influenza vaccine within the last 12 months.
  • Arm: Seasonal Influenza Infected, Recently Vaccinated Cohort
    CLIA-approved influenza test positive in participants with an acute illness and active symptoms of a respiratory viral infection that triggered the clinical testing. Participants in this group received a seasonal influenza vaccine within the last 12 months.
  • Arm: SARS-CoV-2 Infected, Not Recently Vaccinated Cohort
    CLIA-approved SARS-CoV-2 test positive in participants with an acute illness and active symptoms of a respiratory viral infection that triggered the clinical testing. Participants in this group have not received a COVID-19 vaccine within the last 12 months.
  • Arm: SARS-CoV-2 Infected, Recently Vaccinated Cohort
    CLIA-approved SARS-CoV-2 test positive in participants with an acute illness and active symptoms of a respiratory viral infection that triggered the clinical testing. Participants in this group received a COVID-19 vaccine within the last 12 months.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in Saint Louis Department of Emergency Medicine, Emergency Care Research CoreSt LouisMissouri63110
Jamie Mills
[email protected]
314-305-1054

Find similar trials in St Louis, MO

By research site
Washington University in Saint Louis Department of Emergency Medicine, Emergency Care Research Core· St Louis, MO

Related Studies