Randomized Influenza Vaccine Evaluation of Immune Response

Marshfield Clinic Research Foundation366 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

366

Conditions

Influenza

Interventions

Standard inactivated influenza vaccine

RecombinantBIOLOGICAL

Influenza vaccine that uses a hemagglutinin protein manufactured in insect cells with a baculovirus vector

Cell-cultureBIOLOGICAL

inactivated influenza vaccine manufactured using mammalian cell lines; current vaccine uses a cell-propagated H3N2 strain.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States

Outcomes

Primary Outcomes

Post-vaccination titer

geometric mean titers (as measured by microneutralization) to cell-grown A(H3N2) vaccine reference virus

Time frame: 28 days

Data from ClinicalTrials.gov

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