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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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.

Locations
United States
Missouri
Washington University in Saint Louis Department of Emergency Medicine, Emergency Care Research Core
RECRUITING
St Louis
Contact Information
Primary
Jamie Mills
jamiem@wustl.edu
314-305-1054
Time Frame
Start Date: 2025-03-07
Estimated Completion Date: 2029-10
Participants
Target number of participants: 300
Treatments
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.
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.
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.
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov