Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Natural History of Systemic and Nasal Mucosal Immunity After Influenza Vaccination in a Pediatric Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04963166
Recruitment Status : Recruiting
First Posted : July 15, 2021
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Background:

The influenza (flu) virus infects millions around the world every year. Children are at increased risk of complications from the flu. The flu vaccine protects against influenza, but the vaccine can be improved. Researchers want to learn more about children s mucosal and systemic immunity after flu vaccination. This could help to develop more effective flu vaccines in the future.

Objective:

To learn what happens in kids immune systems after receiving a flu vaccine.

Eligibility:

Children ages 2-17 who have received a flu vaccine in the past and plan to get the current seasonal flu vaccine given by injection.

Design:

All study visits will take place at home and communication with the study team will be done via phone or videoconference.

Participants will review medical history and flu vaccination history with the study team.

Participants will get the flu vaccine at their local doctor s office or pharmacy. They will not be given the vaccine in this study.

Participants will complete an electronic survey to give details about the date and type of flu vaccine received.

Participants will collect nasal and fingerstick samples at home. They will collect 4 nasal samples and 3 fingerstick samples over 6 months: once before they get the flu vaccine and 2-3 times after they get the vaccine. They will use collection kits that include instructions, sample collection supplies, and shipping materials. They will ship all samples back to NIH with all costs covered by NIH.

Participation will last for 6 months.

Compensation is provided.


Condition or disease
Influenza Immunity

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History of Systemic and Nasal Mucosal Immunity After Influenza Vaccination in a Pediatric Population
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Cohort 1
2 - 6 year olds
Cohort 2
7 - 11 year olds
Cohort 3
12 - 17 year olds


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Baseline and post-vaccination (6 weeks) systemic anti-influenza antibodies as measured by: 1. Anti-HA head antibody quantitative ELISA IgM, IgG, IgA 2. Anti-HA stalk antibody quantitative ELISA IgM, IgG, IgA 3. Anti-NA antibody quantitative ELIS... [ Time Frame: 6 weeks ]
    HA and NA antibodies are known correlates of protection.

  2. Baseline and post-vaccination (6 weeks) 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 quantitati... [ Time Frame: 6 weeks ]
    HA and NA antibodies are known correlates of protection.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children receiving their first ever influenza vaccine require two doses of the vaccine one month apart and will not be included in this study. Only participants who have already received a flu vaccine series in the past will be eligible for this study. Evaluation of immunity after the first ever influenza vaccination series is an important question that should be explored separately. We will enroll participants into one of three cohorts by age: 2 6 years old, 7 11 years old, and 12 17 years old. We will aim to enroll similar numbers of participants into each group to ensure a diverse age range in our population.
Criteria
  • INCLUSION CRITERIA:

In order to be eligible to enroll in this study, an individual must meet all of the following criteria:

  • >= 2 years of age and < 18 years of age at the time of enrollment.
  • Completed a previous influenza series in the past and therefore requires only one seasonal influenza vaccine every year.
  • Planning to receive the current seasonal inactivated influenza vaccine given by injection.
  • Parent or guardian willing and able to provide verbal consent.
  • Willing and able to undergo home blood micro-sampling and nasal sampling.
  • Willing to have samples stored for future research.
  • Parent/guardian able to proficiently speak, read, and write English.

EXCLUSION CRITERIA:

Any individual who meets any of the following criteria will be excluded from participation in this study:

  • Already received the current season s influenza vaccine.
  • Planning to receive the current seasonal live attenuated influenza vaccine (LAIV).
  • Self-reported pregnancy or breastfeeding.
  • Any condition that, in the opinion of the investigator, would compromise the safety of the study participant or staff, or would prevent proper conduct of the study.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963166


Contacts
Layout table for location contacts
Contact: Alison Han, M.D. (301) 480-5722 alison.han@nih.gov

Locations
Layout table for location information
United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID) Recruiting
Bethesda, Maryland, United States, 20892
Contact: Rani Athota, Ph.D.    301-594-0803    rani.athota@nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Principal Investigator: Alison Han, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04963166    
Other Study ID Numbers: 10000488
000488-I
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: August 19, 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Flu
Flu Shot
Children
Natural History
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases