Background:Influenza (flu) vaccinations are required for all NIH staff members who have directcontact with patients. COVID-19 vaccines are recommended for persons 6 months of age andolder. Researchers want to learn about immunity in NIH staff members who get a flu and/orCOVID-19 vaccine.Objective:To understand what happens to the body s immune system throughout the year after gettingthe 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 vaccineand/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 asurvey 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 fluand SARS-COV-2 vaccines, their participation will be extended.Once a month, participants will be contacted. They will discuss any new medicines, recentvaccinations, 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 willbe placed in the nostril to soak up mucus. Participants will press against the outside oftheir nostril with their finger for 1 minute.Participants may be able to collect samples at home and mail them to NIH if they are notable to visit in person.Participation will last for about 12 13 months.
Study Description:
Yearly influenza vaccination is necessary due to short-lasting influenza immunity and
changing strains of circulating influenza. With limited effectiveness of yearly influenza
vaccines and the ongoing potential for an influenza pandemic, there is a need for a
better understanding of influenza immunity to develop improved vaccines. Severe acute
respiratory syndrome coronavirus 2 (SARS CoV-2) vaccines have been developed in response
to the coronavirus disease 2019 (COVID-19) pandemic. There is a critical need to also
understand the changes in long-term immunity in those who receive a SARS CoV-2 vaccine to
develop improved vaccines. We will investigate the changes in long-term immunity of NIH
workers after vaccination with influenza and/or SARS-CoV-2 and throughout the following
year via blood and nasal sampling.
Objectives:
Primary Objectives:
Characterize the systemic anti-influenza humoral immune response to vaccination over 1
year.
Characterize the systemic anti-SARS-CoV-2 humoral immune response to vaccination over 1
year.
Secondary Objectives:
Characterize the nasal mucosal anti-influenza humoral immune response to vaccination over
1 year.
Characterize the nasal mucosal anti-SARS-CoV-2 humoral immune response to vaccination
over 1 year.
Endpoints:
Primary Endpoints:
1. Systemic anti-influenza antibodies as measured by:
1. Hemagglutination inhibition (HAI) antibody titers
2. Neuraminidase inhibition (NAI) antibody titers
3. Anti-Hemagglutinin (HA) head antibody quantitative enzyme linked immunosorbent
assay (ELISA) (immunoglobulin [Ig] M, IgG, IgA)
4. Anti-HA stalk antibody quantitative ELISA (IgM, IgG, IgA)
5. Anti-Neuraminidase (NA) antibody quantitative ELISA (IgM, IgG, IgA)
2. Systemic anti-SARS-CoV-2 antibodies as measured by:
1. Anti-SARS-CoV-2 spike antibody quantitative ELISA (IgM, IgG, IgA)
2. Anti-SARS-CoV-2 receptor binding domain (RBD) antibody quantitative ELISA (IgM,
IgG, IgA)
Secondary Endpoints:
1. Mucosal anti-influenza antibodies from nasal samples as measured by:
1. Anti-HA head antibody quantitative ELISA (IgA, IgG)
2. Anti-HA stalk antibody quantitative ELISA (IgA, IgG)
3. Anti-NA antibody quantitative ELISA (IgA, IgG)
2. Mucosal anti-SARS-CoV-2 antibodies from nasal samples as measured by:
1. Anti-SARS-CoV-2 spike antibody quantitative ELISA (IgA, IgG)
2. Anti-SARS-CoV-2 RBD antibody quantitative ELISA (IgA, IgG)
Study Population:
NIH staff (N=100) who are 18 years and older. NIH staff may include employees and
contractors, fellows and volunteers. Accrual ceiling N=150.
Description of Sites/Facilities Enrolling Participants:
Participants will be enrolled at the NIH Clinical Center (CC).
Study Duration:
5 years
- 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.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Investigator: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Contact: 800-411-1222
prpl@cc.nih.gov
Rani S Athota, Ph.D.
Not Listed
NIAIDCSUflu@niaid.nih.gov
Alison Han, M.D.
(301) 496-2209
alison.han@nih.gov
Alison Han, M.D., Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)