InfluenzaNCT04794829
Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination
An observational study of Influenza and COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Type of treatment
- Vaccines
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 28 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NIH staff may include employees and contractors, fellows, and volunteers.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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:
- 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
- Keywords
- Flu, Antibody, Immunization, Pandemic, COVID-19, Natural History
- Medical subject headings
- Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | Received influenza and/or SARS-CoV-2 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic anti-SARS-CoV-2 antibodies
Characterize the systemic anti SARS-CoV-2 humoral immune response to vaccination over 1 year.
Measured: One year
Systemic anti-influenza antibodies
Characterize the systemic anti-influenza humoral immune response to vaccination over 1 year.
Measured: One year
Secondary outcomes (2)
Mucosal anti-SARS-CoV-2 antibodies from nasal samples
Characterize the nasal mucosal anti SARS-CoV-2 humoral immune response to vaccination over 1 year.
Measured: One year
Mucosal anti-influenza antibodies from nasal samples
Characterize the nasal mucosal anti-influenza humoral immune response to vaccination over 1 year.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start19 Aug 2021
- Primary completion28 Jul 2026
- Study completion28 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alison Han, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794829
- Sponsor's protocol ID
- 10000256
- Other IDs
- 000256-I
- Status last verified
- 28 Jul 2026
- First submitted
- 11 Mar 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small observational study, not an interventional trial. We will share data as currently outlined in the protocol.
Publications
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.
PubMed 30260944Ferdinands 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.
PubMed 28039340Treanor 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.
PubMed 22843783
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination
- ClinicalTrials.gov ID
- NCT04794829
- Acronym / sponsor ID
- 10000256
- Keywords
- Flu, Antibody, Immunization, Pandemic, COVID-19, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | – | –Received influenza and/or SARS-CoV-2 vaccine |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NIH staff may include employees and contractors, fellows, and volunteers.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Systemic anti-influenza antibodies
Time frame: One year
Characterize the systemic anti-influenza humoral immune response to vaccination over 1 year.
2 secondary outcomes
Mucosal anti-SARS-CoV-2 antibodies from nasal samples
Time frame: One year
Mucosal anti-influenza antibodies from nasal samples
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 30260944Black 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.
- Background: PubMed 28039340Ferdinands 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.
- Background: PubMed 22843783Treanor 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is a small observational study, not an interventional trial. We will share data as currently outlined in the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Han, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic anti-SARS-CoV-2 antibodies (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04794829, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.