Understanding Immunity to the Flu Vaccine in COVID-19 Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flu shot.
- Who it may be relevant to
- Registry conditions: Corona Virus Infection, Flu Vaccine, Immunity. Basic parameters: 9 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Biological Flu shot
All participants will receive a single shot of the flu vaccine
Primary outcome measures
- Testing immunity to the flu vaccine over time [Time frame: 1 week]
- Testing immunity to the flu vaccine over time [Time frame: 1 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Stanford University — Palo Alto
Identifiers
NCT: NCT04579588 · IRB-58356 · 5U19AI057229-17