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OpenTrials
Completed

NCT Number: NCT04794829

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

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.

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Key information

Conditions

Influenza COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza, Human Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

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:

  • Systemic anti-influenza antibodies as measured by:
  • Hemagglutination inhibition (HAI) antibody titers
  • Neuraminidase inhibition (NAI) antibody titers
  • Anti-Hemagglutinin (HA) head antibody quantitative enzyme linked immunosorbent assay (ELISA) (immunoglobulin [Ig] M, IgG, IgA)
  • Anti-HA stalk antibody quantitative ELISA (IgM, IgG, IgA)
  • Anti-Neuraminidase (NA) antibody quantitative ELISA (IgM, IgG, IgA)
  • Systemic anti-SARS-CoV-2 antibodies as measured by:
  • Anti-SARS-CoV-2 spike antibody quantitative ELISA (IgM, IgG, IgA)
  • Anti-SARS-CoV-2 receptor binding domain (RBD) antibody quantitative ELISA (IgM, IgG, IgA)

Secondary Endpoints:

  • Mucosal anti-influenza antibodies from nasal samples as measured by:
  • Anti-HA head antibody quantitative ELISA (IgA, IgG)
  • Anti-HA stalk antibody quantitative ELISA (IgA, IgG)
  • Anti-NA antibody quantitative ELISA (IgA, IgG)
  • Mucosal anti-SARS-CoV-2 antibodies from nasal samples as measured by:
  • Anti-SARS-CoV-2 spike antibody quantitative ELISA (IgA, IgG)
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • 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.
  • Willing and able to undergo blood draws or home blood samplings and nasal sampling procedures.
  • 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:

  • 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.

Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.

Treatment and study plan

Primary outcomes

  1. Systemic anti-SARS-CoV-2 antibodies

    Time frame: One year

    Characterize the systemic anti SARS-CoV-2 humoral immune response to vaccination over 1 year.

  2. Systemic anti-influenza antibodies

    Time frame: One year

    Characterize the systemic anti-influenza humoral immune response to vaccination over 1 year.

Secondary outcomes

  1. Mucosal anti-SARS-CoV-2 antibodies from nasal samples

    Time frame: One year

    Characterize the nasal mucosal anti SARS-CoV-2 humoral immune response to vaccination over 1 year.

  2. Mucosal anti-influenza antibodies from nasal samples

    Time frame: One year

    Characterize the nasal mucosal anti-influenza humoral immune response to vaccination over 1 year.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2021
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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