Randomized Influenza Vaccine Evaluation of Immune Response

Study Overview
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Brief Summary
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Licensed influenza vaccines are manufactured with a variety of technologies. The majority are split, inactivated vaccines derived from egg-adapted, high growth reassortant viruses. Two US licensed products do not use egg-adapted viruses: Flucelvax (mammalian cell culture) and FluBlok (recombinant). There is increasing evidence that egg propagation induces virus mutations that impair the immune responses to circulating viruses. However, the impact of egg-propagation on clinical vaccine effectiveness is uncertain, and there is no preferential recommendation for any specific influenza vaccine product or technology. A direct comparison of serologic response to egg based and non-egg based vaccines in adults has not been performed. This randomized trial will compare serologic responses to the egg- and non-egg A(H3N2) vaccine component. The study cohort will be followed for two influenza seasons to evaluate sequential vaccination effects on immune response.

Official Title
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Randomized Open-Label Trial to Compare Immunogenicity of Egg-Based and Non-Egg Based Quadrivalent Influenza Vaccines Among Adults 18-64 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2018-19 and 2019-20)

Conditions
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Influenza

Intervention / Treatment
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* Biological: Standard IIV4
* Biological: Recombinant
* Biological: Cell-culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-64 years Marshfield Clinic patients living in or around Marshfield, Wisconsin since July 2015 Willing and able to give informed consent and comply with study requirements Exclusion Criteria: Receipt of 2018-19 influenza vaccine prior to study enrollment Known to be pregnant at the time of enrollment Current participation or plans to participate in another clinical trial involving an experimental agent Presence of a contraindication to influenza vaccination Plans to relocate outside the geographic location in the next two years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant (RIV4) Influenza Vaccine<br>A single dose of licensed recombinant influenza vaccine will be given in each of two influenza seasons - one in 2018-19 and a second in 2019-20. | Biological: Recombinant<br>* Influenza vaccine that uses a hemagglutinin protein manufactured in insect cells with a baculovirus vector<br>* Other names: FluBlok Quadrivalent;|
| Experimental: Cell-culture (ccIIV4) Influenza Vaccine<br>A single dose of licensed cell-culture influenza vaccine will be given in each of two influenza seasons - one in 2018-19 and a second in 2019-20 | Biological: Cell-culture<br>* inactivated influenza vaccine manufactured using mammalian cell lines; current vaccine uses a cell-propagated H3N2 strain.<br>* Other names: Flucelvax Quadrivalent;|
| Active Comparator: Standard (IIV4) Influenza Vaccine<br>A single dose of licensed standard influenza vaccine will be given in each of two influenza seasons - one in 2018-19 and a second in 2019-20. | Biological: Standard IIV4<br>* Standard inactivated influenza vaccine<br>* Other names: Flulaval Quadrivalent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-vaccination titer | geometric mean titers (as measured by microneutralization) to cell-grown A(H3N2) vaccine reference virus | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza vaccine, adults, Immune response