Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel
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| ClinicalTrials.gov Identifier: NCT04523324 |
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Recruitment Status :
Completed
First Posted : August 21, 2020
Last Update Posted : October 7, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Influenza | Biological: Flublok™ Quadrivalent by Sanofi, Inc. Biological: VaxigripTetra™ by Sanofi, Inc. | Phase 4 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 572 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Masking Description: | Open-label trial. 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 |
| Actual Study Completion Date : | August 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: RIV4 (Flublok Quadrivalent)
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain
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Biological: Flublok™ Quadrivalent by Sanofi, Inc.
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
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Biological: VaxigripTetra™ by Sanofi, Inc.
0.5 mL intramuscular dose of Vaxigrip |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
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
| Israel | |
| Soroka Medical Center | |
| Be'er Sheva, Israel | |
| Rabin Medical Center-Beilinson | |
| Petah Tikva, Israel | |
| Principal Investigator: | Mark G Thompson, PhD | Centers for Disease Control and Prevention |
| 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: | October 7, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | No current plans |
| 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 |
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Influenza Healthcare personnel Immunogenicity Repeat vaccination |
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Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |