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

NCT04794829 | Recruiting

• 2 other identifiers: 10000256000256-I
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza; COVID-19

Keywords

Flu; Antibody; Immunization; Pandemic; COVID-19; Natural History

Outcome Measures

Primary Outcomes (2)

• Systemic anti-SARS-CoV-2 antibodies

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

  One year

• Systemic anti-influenza antibodies

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

  One year

Secondary Outcomes (2)

• Mucosal anti-SARS-CoV-2 antibodies from nasal samples

  One year

• Mucosal anti-influenza antibodies from nasal samples

  One year

Study Arms (1)

Vaccinated

Received influenza and/or SARS-CoV-2 vaccine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• Black CL, Yue X, Ball SW, Fink RV, de Perio MA, Laney AS, Williams WW, Graitcer SB, Fiebelkorn AP, Lu PJ, Devlin R. Influenza Vaccination Coverage Among Health Care Personnel - United States, 2017-18 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018 Sep 28;67(38):1050-1054. doi: 10.15585/mmwr.mm6738a2.

  PMID: 30260944 BACKGROUND

• Ferdinands JM, Fry AM, Reynolds S, Petrie J, Flannery B, Jackson ML, Belongia EA. Intraseason waning of influenza vaccine protection: Evidence from the US Influenza Vaccine Effectiveness Network, 2011-12 through 2014-15. Clin Infect Dis. 2017 Mar 1;64(5):544-550. doi: 10.1093/cid/ciw816. Epub 2016 Dec 29.

  PMID: 28039340 BACKGROUND

• Treanor JJ, Talbot HK, Ohmit SE, Coleman LA, Thompson MG, Cheng PY, Petrie JG, Lofthus G, Meece JK, Williams JV, Berman L, Breese Hall C, Monto AS, Griffin MR, Belongia E, Shay DK; US Flu-VE Network. Effectiveness of seasonal influenza vaccines in the United States during a season with circulation of all three vaccine strains. Clin Infect Dis. 2012 Oct;55(7):951-9. doi: 10.1093/cid/cis574. Epub 2012 Jul 25.

  PMID: 22843783 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Influenza, Human; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Study Officials

• Alison Han, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rani S Athota, Ph.D.

CONTACT

Not Listed; NIAIDCSUflu@niaid.nih.gov

Alison Han, M.D.

CONTACT

(301) 827-9089; alison.han@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 12, 2021
• Study Start: August 19, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2025-09-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)