Understanding Immunity to the Flu Vaccine in COVID-19 Patients

The purpose of this study is to measure immunity to the flu vaccine over time in patients who had COVID-19. Adults who have been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.

Study Overview

• Status: Recruiting
• Conditions: Corona Virus Infection; Immunity; Flu Vaccine
• Intervention / Treatment: Biological: Flu shot

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: SNP Center Inquiry; Phone Number: (650) 521-7237; Email: snpcenterallergy_inquiry@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: SNP Center Inquiry; Phone Number: 650-521-7237; Email: snpcenterallergy_inquiry@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults (18-64 years) diagnosed and not diagnosed (controls) with COVID-19

Description

Inclusion Criteria:

• Adults enrolled in study 55689 (NCT04373148) or the general population
• Adults diagnosed with severe or moderate COVID-19 at least 2 months prior enrollment
• Adults 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
• Immunodeficiency or autoimmune disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control participants	Biological: Flu shot; All participants will receive a single shot of the flu vaccine
COVID-19 participants	Biological: Flu shot; All participants will receive a single shot of the flu vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Testing immunity to the flu vaccine over time	2 months
Testing immunity to the flu vaccine over time	1 month

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Sayantani Sindher, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: IRB-58356; 5U19AI057229-17 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No