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Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations

Primary Purpose

Influenza, COVID-19

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)
Sequential Vaccination (Influenza vaccine then mRNA COVID booster)
Sequential Vaccination (mRNA COVID booster then Influenza vaccine)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, COVID-19, Immunogencity, Health, Reactogenicity

Eligibility Criteria

6 Years - 64 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy children aged 6-11 years and healthy adults aged 18-64 years that have not received the current season's influenza vaccination or a mRNA COVID-19 vaccination in the past 6 months and have already completed at least a two-dose primary series of an mRNA COVID-19 vaccination English or Spanish literate Email or text message capability for weekly follow-up Intention of receiving influenza vaccine and mRNA COVID-19 vaccine based on ACIP-CDC guidelines Willing to provide written/electronic informed consent Intention of being available for entire study period and able to complete all relevant study procedures, including follow-up phone calls and clinic visits Exclusion Criteria: Self-reported COVID-19 infection within 3 months prior to enrollment Received COVID-19 vaccine within 6 months prior to enrollment Received influenza vaccine during the respective influenza season in which the participants are being enrolled < 9 years of age and recommended to receive two doses of IIV4 during the respective influenza season in which they are being enrolled History of severe allergic reaction after a previous dose of any influenza or COVID-19 mRNA vaccine; or to an influenza or COVID-19 mRNA vaccine component Receipt of any licensed vaccine within 6 weeks prior to enrollment in this study or planning receipt of any vaccines within 4 weeks after the receipt of the second vaccine dose administered during study procedures Has an immunocompromising condition or taking immunosuppressive medication* * Received oral, intramuscular or intravenous systemic immunosuppressants, or immune modifying drugs for >14 days in total within 6 months prior to any study vaccine dose (for corticosteroids ≥ 20 mg/day of prednisone equivalent). ** Note: Topical medications are allowed Received immunoglobulin, SARS-CoV-2 immunoglobulin, SARS-CoV-2 monoclonal antibody, or blood-derived products, within 3 months prior any study vaccine dose. History of Guillain-Barré syndrome History of myocarditis or pericarditis History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A) Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report or likely to be pregnant per screening criteria Bleeding disorder diagnosed by a healthcare provider or bleeding difficulties with intramuscular injections or blood draws. Has injury or other reason why deltoid site on both arms cannot be used for vaccinations Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives Temporary Delay Criteria: History of febrile illness (> 100.0°F or 37.8°C) within the past 72 hours prior to vaccine administration

Sites / Locations

  • Valleywise Health Comprehensive Health CenterRecruiting
  • ASU Biodesign InstituteRecruiting
  • Centers for Disease Control and Prevention
  • Washington University IDCRURecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • VA Northeast Ohio Healthcare System (VANEOHS)Recruiting
  • Senders Pediatrics
  • Department of Family Medicine, University of Pittsburgh School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group i

Group ii

Group iii

Arm Description

Simultaneous Vaccination (Influenza vaccine and mRNA COVID booster) at Visit 1

Sequential vaccination with Influenza vaccination at Visit 1 and mRNA COVID booster at Visit 2

Sequential vaccination with mRNA COVID booster at Visit 1 and Influenza vaccination at Visit 2

Outcomes

Primary Outcome Measures

Change in influenza antibody titer as measured by hemagglutination inhibition (HAI)
Baseline and post-vaccination influenza antibody titer for each ccIIV4 vaccine antigen by hemagglutination inhibition (HAI).
Change in influenza antibody titer as measured by microneutralization (MN)
Baseline and post-vaccination influenza antibody titer for each ccIIV4 vaccine antigen by microneutralization (MN).

Secondary Outcome Measures

Full Information

First Posted
August 30, 2023
Last Updated
October 19, 2023
Sponsor
Duke University
Collaborators
Centers for Disease Control and Prevention, Arizona State University, University Hospitals Cleveland Medical Center, University of Pittsburgh, Washington University School of Medicine, Valleywise Health, VA Northeast Ohio Health Care, Senders Pediatrics
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1. Study Identification

Unique Protocol Identification Number
NCT06020118
Brief Title
Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations
Official Title
Randomized Study of the Immunogenicity and Duration of Antibody Response Against Circulating SARS-CoV-2 Variant and Influenza Viruses Following Concomitant Versus Sequential Administration of mRNA COVID-19 Vaccine and Quadrivalent Cell Culture-based Influenza Vaccine Among Children and Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Centers for Disease Control and Prevention, Arizona State University, University Hospitals Cleveland Medical Center, University of Pittsburgh, Washington University School of Medicine, Valleywise Health, VA Northeast Ohio Health Care, Senders Pediatrics

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites.
Detailed Description
This study is a prospective, randomized comparative immunogenicity study in an enrolled cohort. During this study, eligible participants will be randomly assigned to receive an approved quadrivalent cell culture-based influenza vaccine (ccIIV4, Seqirus) and an approved mRNA COVID-19 vaccine (Moderna) either concomitantly or sequentially, 28 days apart. Participants (aged 6-11 years and 18-64 years) will be enrolled in the 2023-2024 influenza season. Demographic and health data (including influenza and COVID-19 vaccination and infection history) will be collected upon enrollment. Enrolled participants will be randomized to one of the following interventions (2:1:1) (i) concomitant administration of the mRNA COVID-19 vaccine (Moderna) and quadrivalent influenza vaccine (ccIIV4, Seqirus); (ii)sequential administration of the quadrivalent influenza vaccine (ccIIV4, Seqirus) at Visit 1 (day 0) and the mRNA COVID-19 vaccine(Moderna) at Visit 2 (day 28); (iii) sequential administration of the mRNA COVID-19 vaccine (Moderna) at Visit 1 (day 0) followed by the quadrivalent influenza vaccine (ccIIV4, Seqirus) at Visit 2 (day 28). Participants will not be blinded to vaccine group. Whole blood samples to isolate sera for immune assays will be collected prior to vaccination administration at Visit 1 (day 0), Visit 2 (day 28) Visit 3 (day 56; post-vaccination 2) and Visit 4 (day180; end of local flu circulation). Blood samples to isolate PBMC and plasma will be collected from a subset of 250 participants (200 adults and 50 children). If participants exhibit ARI during the study period, the participants may be asked to present for collection of a nasal swab for viral testing for acute influenza or SAR-CoV-2 infection (within 10 days after symptom onset), and blood specimen to isolate sera for immune assays. For participants with confirmed acute infection, the participants may be asked to present for collection of a convalescent-phase blood specimen approximately 28 days after acute visit for isolation of sera, PBMC and plasma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, COVID-19
Keywords
Influenza, COVID-19, Immunogencity, Health, Reactogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group i
Arm Type
Experimental
Arm Description
Simultaneous Vaccination (Influenza vaccine and mRNA COVID booster) at Visit 1
Arm Title
Group ii
Arm Type
Experimental
Arm Description
Sequential vaccination with Influenza vaccination at Visit 1 and mRNA COVID booster at Visit 2
Arm Title
Group iii
Arm Type
Experimental
Arm Description
Sequential vaccination with mRNA COVID booster at Visit 1 and Influenza vaccination at Visit 2
Intervention Type
Biological
Intervention Name(s)
Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)
Intervention Description
Influenza vaccination and mRNA COVID-19 booster will be given at Visit 1.
Intervention Type
Biological
Intervention Name(s)
Sequential Vaccination (Influenza vaccine then mRNA COVID booster)
Intervention Description
Influenza vaccine will be given at Visit 1 and mRNA COVID booster will be given at Visit 2.
Intervention Type
Biological
Intervention Name(s)
Sequential Vaccination (mRNA COVID booster then Influenza vaccine)
Intervention Description
mRNA COVID booster will be given at Visit 1 and Influenza vaccine will be given at Visit 2.
Primary Outcome Measure Information:
Title
Change in influenza antibody titer as measured by hemagglutination inhibition (HAI)
Description
Baseline and post-vaccination influenza antibody titer for each ccIIV4 vaccine antigen by hemagglutination inhibition (HAI).
Time Frame
Visit 1 (baseline), Visit 2 (day 28), and Visit 3 (day 56)
Title
Change in influenza antibody titer as measured by microneutralization (MN)
Description
Baseline and post-vaccination influenza antibody titer for each ccIIV4 vaccine antigen by microneutralization (MN).
Time Frame
Visit 1 (baseline), Visit 2 (day 28), and Visit 3 (day 56)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy children aged 6-11 years and healthy adults aged 18-64 years that have not received the current season's influenza vaccination or a mRNA COVID-19 vaccination in the past 6 months and have already completed at least a two-dose primary series of an mRNA COVID-19 vaccination English or Spanish literate Email or text message capability for weekly follow-up Intention of receiving influenza vaccine and mRNA COVID-19 vaccine based on ACIP-CDC guidelines Willing to provide written/electronic informed consent Intention of being available for entire study period and able to complete all relevant study procedures, including follow-up phone calls and clinic visits Exclusion Criteria: Self-reported COVID-19 infection within 3 months prior to enrollment Received COVID-19 vaccine within 6 months prior to enrollment Received influenza vaccine during the respective influenza season in which the participants are being enrolled < 9 years of age and recommended to receive two doses of IIV4 during the respective influenza season in which they are being enrolled History of severe allergic reaction after a previous dose of any influenza or COVID-19 mRNA vaccine; or to an influenza or COVID-19 mRNA vaccine component Receipt of any licensed vaccine within 6 weeks prior to enrollment in this study or planning receipt of any vaccines within 4 weeks after the receipt of the second vaccine dose administered during study procedures Has an immunocompromising condition or taking immunosuppressive medication* * Received oral, intramuscular or intravenous systemic immunosuppressants, or immune modifying drugs for >14 days in total within 6 months prior to any study vaccine dose (for corticosteroids ≥ 20 mg/day of prednisone equivalent). ** Note: Topical medications are allowed Received immunoglobulin, SARS-CoV-2 immunoglobulin, SARS-CoV-2 monoclonal antibody, or blood-derived products, within 3 months prior any study vaccine dose. History of Guillain-Barré syndrome History of myocarditis or pericarditis History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A) Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report or likely to be pregnant per screening criteria Bleeding disorder diagnosed by a healthcare provider or bleeding difficulties with intramuscular injections or blood draws. Has injury or other reason why deltoid site on both arms cannot be used for vaccinations Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives Temporary Delay Criteria: History of febrile illness (> 100.0°F or 37.8°C) within the past 72 hours prior to vaccine administration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel B Walter, MD, MPH
Phone
(919) 970-5720
Email
chip.walter@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Grace N Davis, MS
Phone
(919) 385-5786
Email
grace.davis@duke.edu
Facility Information:
Facility Name
Valleywise Health Comprehensive Health Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lora Nordstrom, BSN, PhD
Phone
602-344-2759
Email
Lora.Nordstrom@ValleywiseHealth.org
First Name & Middle Initial & Last Name & Degree
Mary Mulrow, RN, MSN
Phone
602-344-5058
Email
Mary.Mulrow@ValleywiseHealth.org
First Name & Middle Initial & Last Name & Degree
Michael White, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey Curtis, MD
Facility Name
ASU Biodesign Institute
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vel Murugan, PhD, MBA
Phone
480-727-0402
Email
Vel.murugan@asu.edu
First Name & Middle Initial & Last Name & Degree
Mario Islas, MD
Phone
480-965-7005
Email
mario.islas@asu.edu
First Name & Middle Initial & Last Name & Degree
Vel Murugan, PhD, MBA
Facility Name
Centers for Disease Control and Prevention
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30333
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendan Flannery, PhD
Phone
404-718-4276
Email
bflannery@cdc.gov
First Name & Middle Initial & Last Name & Degree
Kelsey Sumner, PhD, MSPH
Phone
404-639-0546
Email
rhq3@cdc.gov
Facility Name
Washington University IDCRU
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Presti, MD, PhD
Phone
314-454-0058
Email
prestir@wustl.edu
First Name & Middle Initial & Last Name & Degree
Michael Klebert, PhD, RNP
Phone
314-454-0058
Email
mklebert@wustl.edu
First Name & Middle Initial & Last Name & Degree
Michael Klebert, PhD, RNP
First Name & Middle Initial & Last Name & Degree
Luis Parra-Rodriguez
First Name & Middle Initial & Last Name & Degree
Adriana Rauseo
First Name & Middle Initial & Last Name & Degree
Shashwatee Bagchi
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheree White, BSN
Phone
216-286-7589
Email
sheree.white@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Kieran McKibben, BSN
Phone
216-286-7589
Email
kieran.mckibben@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Elie Saade, MD
First Name & Middle Initial & Last Name & Degree
Claudia Hoyen, MD
First Name & Middle Initial & Last Name & Degree
Robert Salata, MD
Facility Name
VA Northeast Ohio Healthcare System (VANEOHS)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy Lawrence
Phone
216-791-3800
Ext
65103
Email
Joy.Lawrence@va.gov
First Name & Middle Initial & Last Name & Degree
Martin Varghese
Phone
216-791-3800
Ext
64788
Email
Martin.Vaghese@va.gov
First Name & Middle Initial & Last Name & Degree
Curtis Donskey
Facility Name
Senders Pediatrics
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelly Senders, MD
Phone
216-291-9210
Email
ssenders@senderspediatrics.com
First Name & Middle Initial & Last Name & Degree
Timonthy Hudec, BA
Phone
216-658-2408
Email
thudec@sendersresearch.com
First Name & Middle Initial & Last Name & Degree
Shelly Senders, MD
Facility Name
Department of Family Medicine, University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Williams, MD, MPH
Phone
412-383-1979
Email
kvw3@pitt.edu
First Name & Middle Initial & Last Name & Degree
Tricia Nowalk, PhD, RDN
Phone
412-383-2355
Email
tnowalk@pitt.edu
First Name & Middle Initial & Last Name & Degree
Richard Zimmerman, MD,MPH
First Name & Middle Initial & Last Name & Degree
Tricia Nowalk, PhD, RDN

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations

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