About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Already received the current season s influenza vaccine and does not plan to receive an FDA-authorized or approved SARS CoV-2 vaccine.
Already received an FDA-authorized or approved SARS-CoV-2 vaccine and does not plan to receive the current season s influenza vaccine.
Not willing to receive the current influenza season's vaccine and not willing to receive an FDA-authorized or approved SARS-CoV-2 vaccine.
Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Trial population
NIH staff may include employees and contractors, fellows, and volunteers.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Systemic anti-SARS-CoV-2 antibodies
Characterize the systemic anti SARS-CoV-2 humoral immune response to vaccination over 1 year.
Systemic anti-influenza antibodies
Characterize the systemic anti-influenza humoral immune response to vaccination over 1 year.
Secondary outcomes
Mucosal anti-SARS-CoV-2 antibodies from nasal samples
Characterize the nasal mucosal anti SARS-CoV-2 humoral immune response to vaccination over 1 year.
Mucosal anti-influenza antibodies from nasal samples
Characterize the nasal mucosal anti-influenza humoral immune response to vaccination over 1 year.
Sponsors and contacts
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