RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-19
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04794829

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.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. NIH staff members, at the time of enrollment.
  2. 2. Able to provide informed consent.
  3. 3. \>=18 years of age.
  4. 4. Planning to receive the current influenza season s vaccine and/or an FDA-authorized or approved SARS-CoV-2 vaccine.
  5. 5. Willing and able to undergo blood draws or home blood samplings and nasal sampling procedures.
  6. 6. Willing and able to undergo at least one blood draw and one nasal sampling prior to receiving vaccine.
  1. 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. 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. 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. 4. Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Contacts and Locations

Study Contact

Rani S Athota, Ph.D.
CONTACT
Not Listed
NIAIDCSUflu@niaid.nih.gov
Alison Han, M.D.
CONTACT
(301) 496-2209
alison.han@nih.gov

Principal Investigator

Alison Han, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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

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 Registration Dates

Study Start Date2021-08-19
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-08-19
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Influenza
  • COVID-19