Egg-based vs. Non-egg-based Flu Vaccines for Influenza

(RIVER Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Marshfield Clinic Research Foundation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 18-64 who are patients at the Marshfield Clinic in Wisconsin and have been living there since July 2015. Participants must be able to consent and follow study rules. Pregnant individuals, those already vaccinated for flu this season, or involved in another clinical trial with an experimental agent cannot join.

Inclusion Criteria

Marshfield Clinic patients living in or around Marshfield, Wisconsin since July 2015

Willing and able to give informed consent and comply with study requirements

You are between 18 and 64 years old.

Exclusion Criteria

Plans to relocate outside the geographic location in the next two years

Known to be pregnant at the time of enrollment

Current participation or plans to participate in another clinical trial involving an experimental agent

Treatment Details

Interventions

• Cell-culture (Inactivated Vaccine)
• Recombinant (Recombinant Vaccine)
• Standard IIV4 (Inactivated Vaccine)

Trial Overview The study compares immune responses to two types of flu vaccines: one grown in eggs (Standard IIV4) and two not grown in eggs (Flucelvax from cell culture & FluBlok recombinant). It aims to see if non-egg-based vaccines produce a better immune response over two flu seasons.

Participant Groups

Group I: Recombinant (RIV4) Influenza Vaccine Experimental Treatment 1 Intervention

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.

Group II: Cell-culture (ccIIV4) Influenza Vaccine Experimental Treatment 1 Intervention

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

Group III: Standard (IIV4) Influenza Vaccine Active Control 1 Intervention

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Marshfield Clinic - Marshfield Center Marshfield, WI

Who Is Running the Clinical Trial?

Marshfield Clinic Research Foundation Lead Sponsor

Centers for Disease Control and Prevention Collaborator

References