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 : December 1, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 detailed description
| 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 : | December 6, 2021 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
| Group/Cohort |
|---|
|
Cohort 1
2 - 6 year olds
|
|
Cohort 2
7 - 11 year olds
|
|
Cohort 3
12 - 17 year olds
|
- 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.
- 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.
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.
| Ages Eligible for Study: | 2 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- 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.
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
| Contact: Alison Han, M.D. | (301) 480-5722 | alison.han@nih.gov |
| 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 | |
| Principal Investigator: | Alison Han, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
| 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: | December 1, 2021 |
| Last Verified: | August 19, 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Flu Flu Shot Children |
|
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |