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

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Recruiting
• CT.gov ID: NCT04794829
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 64.4
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

Background:

Influenza (flu) vaccinations are required for all NIH staff members who have direct contact with patients. SARS-CoV-2 vaccines are available to NIH staff. These vaccines are shown to be effective. Researchers want to learn about immunity in NIH staff members who get a flu and/or SARS-CoV-2 vaccine.

Objective:

To understand what happens to the body s immune system throughout the year after getting the flu and/or SARS-CoV-2 vaccine.

Eligibility:

Adults ages 18 and older who work at NIH and plan to get the current season s flu vaccine and/or SARS-CoV-2 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.

Condition or Disease	Intervention/Treatment	Phase
Influenza; COVID-19

Detailed Description

Title:

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

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:

2. Hemagglutination inhibition (HAI) antibody titers

3. Neuraminidase inhibition (NAI) antibody titers

4. Anti-Hemagglutinin (HA) head antibody quantitative enzyme linked immunosorbent assay (ELISA) (immunoglobulin [Ig] M, IgG, IgA)

5. Anti-HA stalk antibody quantitative ELISA (IgM, IgG, IgA)

6. Anti-Neuraminidase (NA) antibody quantitative ELISA (IgM, IgG, IgA)

7. Systemic anti-SARS-CoV-2 antibodies as measured by:

8. Anti-SARS-CoV-2 spike antibody quantitative ELISA (IgM, IgG, IgA)

9. 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:

2. Anti-HA head antibody quantitative ELISA (IgA, IgG)

3. Anti-HA stalk antibody quantitative ELISA (IgA, IgG)

4. Anti-NA antibody quantitative ELISA (IgA, IgG)

5. Mucosal anti-SARS-CoV-2 antibodies from nasal samples as measured by:

6. Anti-SARS-CoV-2 spike antibody quantitative ELISA (IgA, IgG)

7. 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

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination
• Actual Study Start Date: Aug 19, 2021
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Vaccinated Received influenza and/or SARS-CoV-2 vaccine

Outcome Measures

Primary Outcome Measures

1. Systemic anti-SARS-CoV-2 antibodies [One year]

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

2. Systemic anti-influenza antibodies [One year]

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

Secondary Outcome Measures

1. Mucosal anti-SARS-CoV-2 antibodies from nasal samples [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 [One year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NIH Clinical Center Detailed Web Page

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.
• 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.
• 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. Epub 2012 Jul 25.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT04794829
• Other Study ID Numbers: 10000256; 000256-I
• First Posted: Mar 12, 2021
• Last Update Posted: Jul 7, 2022
• Last Verified: Jan 31, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Flu; Antibody; Immunization; Pandemic; COVID-19; Natural History
• Additional relevant MeSH terms: COVID-19; Influenza, Human

Study Results

No Results Posted as of Jul 7, 2022