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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04963166
Recruitment Status : Active, not recruiting
First Posted : July 15, 2021
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Description
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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

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Study Design
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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History of Systemic and Nasal Mucosal Immunity After Influenza Vaccination in a Pediatric Population
Actual Study Start Date : September 24, 2021
Actual Primary Completion Date : July 22, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Groups and Cohorts
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Group/Cohort
12-17 years of age
12-17 years of age
2-6 years of age
2-6 years of age
7-11 years of age
7-11 years of age


Outcome Measures
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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 ]
    Systemic anti-influenza antibodies

  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 ]
    Mucosal anti-influenza antibodies


Secondary Outcome Measures :
  1. post-vaccination systemic anti-influenza antibodies [ Time Frame: 24 weeks ]
    Systemic anti-influenza antibodies

  2. post-vaccination mucosal anti-influenza antibodies [ Time Frame: 24 weeks ]
    Mucosal anti-influenza antibodies


Eligibility Criteria
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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.


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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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


Locations
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United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Alison Han, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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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 13, 2023
Last Verified: May 18, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: .This is a small observational study, not an interventional trial, involving pediatric participants.

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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:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases