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Trial record 2 of 12 for:    flublok | influenza | Phase 4

Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel

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ClinicalTrials.gov Identifier: NCT04523324
Recruitment Status : Active, not recruiting
First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Sponsor:
Collaborators:
Abt Associates
Clalit Research Institute
Soroka University Medical Center
Rabin Medical Center
University of Michigan
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Brief Summary:
This randomized, single-blind, active-controlled trial will assess humoral immune responses to a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4) compared with standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among healthcare personnel (HCP) vaccinated during the previous 2018-19 season with IIV4. The trial will be conducted at two hospital sites in Israel during the 2019-20 influenza season among HCP who were enrolled in the Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI).

Condition or disease Intervention/treatment Phase
Influenza Biological: Flublok™ Quadrivalent by Sanofi, Inc. Biological: VaxigripTetra™ by Sanofi, Inc. Phase 4

Detailed Description:

This is a randomized, single-blind 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. Participants will be blinded to the vaccine that they vaccine, but study staff will be aware of the vaccine. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 572 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single-blind trial: participants will be blinded to the vaccine that they receive, study staff will not be blinded. Eligible HCP who report already having been vaccinated with Vaxigrip at the time they are approached to join the study will be eligible to participate.
Primary Purpose: Basic Science
Official Title: Randomized Comparison of the Immunogenicity of Recombinant and Egg-based Influenza Vaccines Among Healthcare Personnel in Israel
Actual Study Start Date : October 31, 2019
Actual Primary Completion Date : January 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: RIV4 (Flublok Quadrivalent)
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain
Biological: Flublok™ Quadrivalent by Sanofi, Inc.
0.5 mL intramuscular dose of Flublok

Active Comparator: IIV4 (Vaxigrip Quadrivalent)
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based
Biological: VaxigripTetra™ by Sanofi, Inc.
0.5 mL intramuscular dose of Vaxigrip




Primary Outcome Measures :
  1. Geometric Mean Titers (GMT) Pre- and Post-vaccination [ Time Frame: Day 0 and 28 days after vaccination ]
    The geometric mean of antibody titers before and following a single dose of RIV4 versus IIV4 as measured by hemagglutination inhibition (HI) for egg-grown influenza viruses A/H1N1, B/Yamagata, and B/Victoria, and egg-grown and cell-grown A/H3N2, and microneutralization (MN) for egg-grown and cell-grown A/H3N2 viruses.

  2. Geometric Mean Titer Ratio (GMR) for Each Virus Strain [ Time Frame: 28 days after vaccination ]
    The ratio of the post-vaccination titer for each virus strain following a single dose of RIV4 versus IIV4.

  3. Seroconversion Rate (SCR) Difference for Each Virus Strain [ Time Frame: 28 days after vaccination ]
    The proportion of participants with paired samples that achieved ≥4-fold rises comparing post- versus pre-vaccination titers, and post vaccination titers ≥40 for each virus strain following a single dose of RIV4 versus IIV4.

  4. Geometric Mean Fold Rise (MFR) of Each Virus Strain [ Time Frame: 28 days after vaccination ]
    The ratio of the post-vaccination titer value to the pre-vaccination value for each virus strain following a single dose of RIV4 versus IIV4.

  5. Elevated Post-vaccination Titer [ Time Frame: 28 days after vaccination ]
    Elevated post-vaccination serum titers at thresholds greater than 1:40, 1:80, 1:160 for each virus strain following a single dose of RIV4 versus IIV4.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523324


Locations
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Israel
Soroka Medical Center
Be'er Sheva, Israel
Rabin Medical Center-Beilinson
Petah Tikva, Israel
Sponsors and Collaborators
Centers for Disease Control and Prevention
Abt Associates
Clalit Research Institute
Soroka University Medical Center
Rabin Medical Center
University of Michigan
Investigators
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Principal Investigator: Mark G Thompson, PhD Centers for Disease Control and Prevention
Publications:
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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT04523324    
Other Study ID Numbers: 7250
200-2016-91806 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plans

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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
Keywords provided by Centers for Disease Control and Prevention:
Influenza
Healthcare personnel
Immunogenicity
Repeat vaccination
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases