- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523324
Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel
Randomized Comparison of the Immunogenicity of Recombinant and Egg-based Influenza Vaccines Among Healthcare Personnel in Israel
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, open-label study design. Starting in July 2019, approximately 550 to 700 HCP from two hospitals (275-350 per hospital site) in Israel will be enrolled. Following completion of a written consent form, participants will complete an enrollment survey and grant permission for review of information collected during the SHIRI study, including vaccination status and immune response during the SHIRI study years. Participants will complete an enrollment survey and grant permission to include and integrate information collected during the SHIRI study into the current study's data, including health history, influenza vaccination history, and immune response to vaccination during the SHIRI study years. HCP will be randomly assigned 1:1 to receive a single dose of IIV4 licensed in Israel (expected to be Vaxigrip® Quadrivalent, 15µg of HA per strain) or RIV4 (Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain) during August-October of 2019. Adverse events following vaccination will be monitored and documented. Blood specimens will be collected prior to vaccination and approximately 28 days after to evaluate immune responses to vaccination.
Eligible HCP who were already vaccinated with Vaxigrip, the vaccine that is routinely available in Israel, at the time they are approached to join the study, will be invited to join the study as part of the Vaxigrip arm. Like randomized participants, participants who were vaccinated with Vaxigrip outside the study will complete a written consent form, an enrollment survey and grant permission for review of information collected during the SHIRI study, including vaccination status and immune response during the SHIRI study years. As part of the consent form, participants will record the estimated date that they received the vaccine, and the location, and will authorize study staff to verify the date of current-year Vaxigrip vaccination in the Clalit EMR and with the hospital vaccination staff. Participants will complete an enrollment survey and grant permission to include and integrate information collected during the SHIRI study into the current study's data, including health history, influenza vaccination history, and immune response to vaccination during the SHIRI study years. Blood specimens will be collected approximately 28 days after to evaluate immune responses to vaccination.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Be'er Sheva, Israel
- Soroka Medical Center
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Petah Tikva, Israel
- Rabin Medical Center-Beilinson
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged ≥18
- Current member of Clalit Health Services
- Consent to randomized receipt of influenza vaccination with either RIV4 or IIV4, or, if already vaccinated in the current year outside of the study, consent to receive a post-vaccination blood draw
- Participated in the SHIRI study and received influenza vaccination during the 2018-19 influenza season (Group 1)
- Participated in any year of the SHIRI study, not vaccinated in 2018-2019, but vaccinated in at least one study year (Group 1 supplemental)
- Participated in the SHIRI study during all three years, regardless of vaccination status (Group 1 supplemental)
- Participated in any year of the SHIRI study and had PCR-confirmed influenza virus infection during any of the three study years (Group 2)
Exclusion Criteria:
- Already received an influenza vaccine during the current influenza season
- Not willing or able to get the flu vaccines being used in this study;
- Previous hypersensitivity reaction to the study vaccines, or any vaccine, as reported by the subject
- Received any non-influenza vaccine (e.g., Hepatitis B or other vaccine recommended for HCP) in the 4 weeks prior to the first study visit or plans to receive a vaccine in the 4 weeks following the first study visit
- Currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication), or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive an experimental agent during participation in this study.
- Any condition or employment status that the potential participant or local study site principle investigator (PI) believes may interfere with successful completion of the study prior to December 2019, including being currently pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: RIV4 (Flublok Quadrivalent)
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain
|
0.5 mL intramuscular dose of Flublok
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Active Comparator: IIV4 (Vaxigrip Quadrivalent)
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based
|
0.5 mL intramuscular dose of Vaxigrip
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-vaccination Geometric Mean Titer Against Influenza Virus A/H1N1
Time Frame: Day 28 days after vaccination
|
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for influenza virus A/H1N1
|
Day 28 days after vaccination
|
Geometric Mean Titer Ratio (GMR) Against Influenza Virus A/H1N1
Time Frame: 0 to 28 days after vaccination
|
The ratio of the pre- vs. post-vaccination titer against influenza virus A/H1N1 following a single dose of RIV4 versus IIV4.
|
0 to 28 days after vaccination
|
Post-vaccination Geometric Mean Titer Against Egg-grown Influenza Virus A/H3N2
Time Frame: Day 28 days after vaccination
|
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for egg-grown influenza virus A/H3N2
|
Day 28 days after vaccination
|
Geometric Mean Titer Ratio (GMR) Against Egg-grown Influenza Virus A/H3N2
Time Frame: 0 to 28 days after vaccination
|
The ratio of the pre- vs. post-vaccination titer against egg-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4.
|
0 to 28 days after vaccination
|
Post-vaccination GMT Against Cell-grown Influenza Virus A/H3N2
Time Frame: Day 28 days after vaccination
|
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for cell-grown influenza virus A/H3N2
|
Day 28 days after vaccination
|
Geometric Mean Titer Ratio (GMR) Against Cell-grown Influenza Virus A/H3N2
Time Frame: 0 to 28 days after vaccination
|
The ratio of the pre- vs. post-vaccination titer against cell-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4.
|
0 to 28 days after vaccination
|
Post-vaccination Geometric Mean Titer Against Influenza B(Victoria)
Time Frame: Day 28 days after vaccination
|
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Victoria)
|
Day 28 days after vaccination
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Geometric Mean Titer Ratio (GMR) Against Influenza B(Victoria)
Time Frame: 0 to 28 days after vaccination
|
The ratio of the pre- vs. post-vaccination titer against Influenza B(Victoria) following a single dose of RIV4 versus IIV4.
|
0 to 28 days after vaccination
|
Post-vaccination Geometric Mean Titer Against Influenza B(Yamagata)
Time Frame: Day 28 days after vaccination
|
The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Yamagata)
|
Day 28 days after vaccination
|
Geometric Mean Titer Ratio (GMR) Against Influenza B(Yamagata)
Time Frame: 0 to 28 days after vaccination
|
The ratio of the pre- vs. post-vaccination titer against Influenza B(Yamagata) following a single dose of RIV4 versus IIV4.
|
0 to 28 days after vaccination
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum antibody responses to cell-grown wild-type influenza viruses
Time Frame: 28 days after vaccination
|
GMT, SCR, GMR, MFR, and elevated post-vaccination titers following a single dose of RIV4 versus IIV4 as measured by HI and MN, as appropriate.
|
28 days after vaccination
|
GMT as measured by neuraminidase inhibition assay (NAI) pre- and post-vaccination
Time Frame: 28 days after vaccination
|
GMT as measured by NAI pre- and post-vaccination following a single dose of RIV4 versus IIV4.
|
28 days after vaccination
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark G Thompson, PhD, Centers for Disease Control and Prevention
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7250
- 200-2016-91806 (Other Grant/Funding Number: Centers for Disease Control and Prevention)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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