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

Description

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