Understanding Immunity to the Flu Vaccine in COVID-19 Patients

NCT ID: NCT04579588

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-29

Study Completion Date

2026-04-30

Brief Summary

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The purpose of this study is to measure immunity to the flu vaccine over time in patients who have had COVID-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term COVID-19 symptoms. Adults and children (age 9 to 64) who had been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.

Detailed Description

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Conditions

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Corona Virus Infection Flu Vaccine Immunity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 participants

Flu shot

Intervention Type BIOLOGICAL

All participants will receive a single shot of the flu vaccine

Control participants

Flu shot

Intervention Type BIOLOGICAL

All participants will receive a single shot of the flu vaccine

Interventions

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Flu shot

All participants will receive a single shot of the flu vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age 9 through 64 years
* Diagnosed with COVID-19 at least 2 months prior enrollment
* Patients with or without obesity, diabetes, chronic fatigue and/or long term COVID-19 symptoms
* Patients without COVID-19 diagnosis for controls

Exclusion Criteria

* Received the influenza vaccine less than 4 months ago
* Pregnant or lactating
* Patients with special risks attendant to venipuncture
* Use of immunomodulatory medications that may impact vaccine immune response per clinician's judgment
* Contraindication to the flu vaccine
* Immunodeficiency or autoimmune disease that may impact vaccine immune responses per clinician's judgement
Minimum Eligible Age

9 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sayantani B. Sindher

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sayantani Sindher, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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SNP Center Inquiry

Role: CONTACT

Phone: (650) 521-7237

Email: [email protected]

Facility Contacts

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SNP Center Inquiry

Role: primary

Other Identifiers

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5U19AI057229-17

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-58356

Identifier Type: -

Identifier Source: org_study_id