Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults Afte… (NCT04794829) | Clinical Trial Compass
RecruitingNot Applicable
Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination
United States150 participantsStarted 2021-08-19
Plain-language summary
Background:
Influenza (flu) vaccinations are required for all NIH staff members who have direct contact with patients. COVID-19 vaccines are recommended for persons 6 months of age and older. Researchers want to learn about immunity in NIH staff members who get a flu and/or COVID-19 vaccine.
Objective:
To understand what happens to the body s immune system throughout the year after getting the flu and/or COVID-19 vaccine.
Eligibility:
Adults ages 18 and older who work at NIH and plan to get the current season s flu vaccine and/or COVID-19 vaccine.
Design:
Participants will not get any vaccines as part of this study.
Participants will be screened with a medical history and medicine review. They will get a survey via email. It will ask about their flu and SARS-CoV-2 history and vaccinations.
Participants will have 12 monthly visits at NIH. If during that year they get both flu and SARS-COV-2 vaccines, their participation will be extended.
Once a month, participants will be contacted. They will discuss any new medicines, recent vaccinations, or changes in medical history.
Once a month, participants will have blood drawn.
Once a month, participants will have nasal sampling. A small, flat absorptive strip will be placed in the nostril to soak up mucus. Participants will press against the outside of their nostril with their finger for 1 minute.
Participants may be able to collect samples at home and mail them to NIH if they are not able to visit in person.
Participation will last for about 12 13 months.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. NIH staff members, at the time of enrollment.
. Able to provide informed consent.
. \>=18 years of age.
. Planning to receive the current influenza season s vaccine and/or an FDA-authorized or approved SARS-CoV-2 vaccine.
. Willing and able to undergo blood draws or home blood samplings and nasal sampling procedures.
. Willing and able to undergo at least one blood draw and one nasal sampling prior to receiving vaccine.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Systemic anti-SARS-CoV-2 antibodies
Timeframe: One year
2
Systemic anti-influenza antibodies
Timeframe: One year
Trial details
NCT IDNCT04794829
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)