NCT04794829 Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination
| NCT ID | NCT04794829 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Influenza |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-08-19 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2021-08-19 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. NIH staff members, at the time of enrollment. 2. Able to provide informed consent. 3. \>=18 years of age. 4. Planning to receive the current influenza season s vaccine and/or an FDA-authorized or approved SARS-CoV-2 vaccine. 5. Willing and able to undergo blood draws or home blood samplings and nasal sampling procedures. 6. Willing and able to undergo at least one blood draw and one nasal sampling prior to receiving vaccine. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Already received the current season s influenza vaccine and does not plan to receive an FDA-authorized or approved SARS CoV-2 vaccine. 2. Already received an FDA-authorized or approved SARS-CoV-2 vaccine and does not plan to receive the current season s influenza vaccine. 3. Not willing to receive the current influenza season's vaccine and not willing to receive an FDA-authorized or approved SARS-CoV-2 vaccine. 4. Any condition that, in the opinion of the investigator, contraindicates participation in this study. Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.
Contact & Investigator
Alison Han, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT04794829 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Influenza. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04794829 currently recruiting?
Yes, NCT04794829 is actively recruiting participants. Contact the research team at NIAIDCSUflu@niaid.nih.gov for enrollment information.
Where is the NCT04794829 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04794829 clinical trial?
NCT04794829 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Alison Han, M.D. at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 150 participants.