Understanding Immunity to the Flu Vaccine in COVID-19 Patients

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04579588
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 37
• Location: 1
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Infection; Flu Vaccine; Immunity	Biological: Flu shot

Study Design

• Study Type: Observational
• Actual Enrollment: 37 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Understanding Immunity to the Flu Vaccine in COVID-19 Patients
• Actual Study Start Date: Oct 29, 2020
• Actual Primary Completion Date: Mar 15, 2021
• Actual Study Completion Date: Mar 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Testing immunity to the flu vaccine over time [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adults enrolled in study 55689 (NCT04373148)

• Adults diagnosed with severe or moderate COVID-19 at least 2 months prior enrollment

• Adults without COVID-19 diagnosis for healthy controls

• Healthy controls may also be recruited outside of IRB#55689

Exclusion Criteria:

• Received the influenza vaccine less than 4 months ago

• Pregnant or lactating

• Patients with special risks attendant to venipuncture

• Adults who test positive for COVID-19 (pcr test)

• Use of immunomodulatory medications

• Immunodeficiency or autoimmune disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University, Hospital, and Clinics	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Kari Nadeau, MD, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kari Christine Nadeau, MD, PhD, Professor of Medicine, Stanford University
• ClinicalTrials.gov Identifier: NCT04579588
• Other Study ID Numbers: IRB-58356; 5U19AI057229-17
• First Posted: Oct 8, 2020
• Last Update Posted: Sep 20, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Coronavirus Infections

Study Results

No Results Posted as of Sep 20, 2021