Randomized Influenza Vaccine Evaluation of Immune Response (RIVER)

Marshfield Clinic Research Foundation

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Recombinant; Biological: Cell-culture; Biological: Standard IIV4

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03598439

MCL10218

Details and patient eligibility

About

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.

Enrollment: 366 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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366 participants in 3 patient groups

Recombinant (RIV4) Influenza Vaccine

Experimental group

Description:

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.

Treatment:

Biological: Recombinant

Cell-culture (ccIIV4) Influenza Vaccine

Experimental group

Description:

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

Treatment:

Biological: Cell-culture

Standard (IIV4) Influenza Vaccine

Active Comparator group

Description:

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.

Treatment:

Biological: Standard IIV4