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

March 14, 2024 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health Clinical Center
        • Contact:
        • Contact:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • Phone Number: TTY8664111010 800-411-1222
          • Email: prpl@cc.nih.gov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

NIH staff may include employees and contractors, fellows, and volunteers.

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Vaccinated
Received influenza and/or SARS-CoV-2 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year
Systemic anti-influenza antibodies
Time Frame: One year
Characterize the systemic anti-influenza humoral immune response to vaccination over 1 year.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year
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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Alison Han, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 13, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10000256
  • 000256-I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

.This is a small observational study, not an interventional trial. We will share data as currently outlined in the protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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