Understanding immunity to flu and COVID-19 vaccines in NIH staff

Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination

This study looks at how the immune systems of NIH staff respond to the flu and COVID-19 vaccines over a year to better understand their protection against these viruses.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT04794829 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the immune responses of NIH staff members who receive the flu and/or COVID-19 vaccines. Participants, aged 18 and older, will undergo monthly visits for one year, during which blood and nasal samples will be collected to assess their immune responses. The study will focus on characterizing both systemic and nasal mucosal immunity to influenza and SARS-CoV-2 over time. Participants will not receive any vaccines as part of the study but will be monitored for their vaccination history and immune response.

Who should consider this trial

Good fit: Ideal candidates for this study are NIH staff members aged 18 and older who plan to receive the current season's flu and/or COVID-19 vaccine.

Not a fit: Patients who have already received the current season's influenza vaccine or the SARS-CoV-2 vaccine and do not plan to receive the other will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved vaccine formulations and strategies for better protection against influenza and COVID-19.

How similar studies have performed: While this study focuses on a specific population, similar studies have shown success in understanding vaccine-induced immunity, making this approach promising.

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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Alison Han, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Rani S Athota, Ph.D.

Conditions: Influenza, COVID-19, Flu, Antibody, Immunization, Pandemic, Natural History