FLU-VACS
Comparative Study of Influenza Vaccines in Adults

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Enrollment Begins in Fall 2007

Who and what we are ...

The FLU-VACS research study is being conducted by investigators from the University of Michigan School of Public Health in cooperation with Central Michigan University, Eastern Michigan University and Western Michigan University.

The purpose of the FLU-VACS research study is to compare two licensed influenza vaccines to each other and to placebo (a preparation similar to vaccine but with no active ingredients). Influenza is a serious respiratory illness caused by a group of viruses. Influenza outbreaks occur every year usually in the winter months. Vaccination is the first line of defense against influenza. People who are vaccinated are usually protected because their bodies respond to the material included in the vaccine by making antibodies which fight infection – this is known as the immune response. Two vaccines are licensed for use in the prevention of influenza – one is the inactivated (killed) influenza vaccine (product name Fluzone) which is given as an injection (“flu shot”), and the other is the newer live-attenuated (weakened) influenza vaccine (product name FluMist) which is given by nasal spray. Both are approved and licensed by the U.S. Food and Drug Administration for use in healthy adults under age 50 years. While both vaccines appear to be effective in most years, there may be variation in effectiveness from year to year. We are trying to identify reasons for this variation. In order to test the vaccines, we will need to perform laboratory tests on blood specimens from you to measure your immune response to vaccination. We will also need to perform laboratory tests on throat swab specimens from you if you have a respiratory illness. Our research study will help to determine how the vaccines will be used to control influenza outbreaks, and assist in pandemic planning.

Study details...

Detailed descriptions of the study procedures will be given in a consent form, which should be read carefully at the enrollment visit. Only those persons who are eligible (see inclusion criteria) for the study will be allowed to participate.

The study will be conducted among healthy adult participants aged 18-49 years and is expected to last approximately one year. Participants will be assigned by chance to receive one of the two, licensed influenza vaccines (83% chance) or placebo (17% chance), given either as nasal spray (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo). Participants and staff will not be able to select or change the medication assignment, nor will they know whether vaccine or placebo is given. Blood specimens will be collected at each of three scheduled visits in order to measure how your body responds to vaccination and/or how well you were protected from influenza infection. During the influenza season, participants with influenza-like illness will provide information on symptoms and come in for collection of a throat culture (swab) specimen for virus identification.

Compensation...

Study participants who complete the three scheduled study visits - enrollment/vaccination visit, one month follow-up visit and end of season visit – will receive at least $100 ($30 for each of the first two visits and $40 for the third visit); additional compensation ($25 per visit) will be received in the event of influenza-like illness with specimen collection (throat swab) for virus identification. Compensation for the first two study visits (enrollment and follow-up) will be distributed at the time of the follow-up visit. Compensation for any illness visits and the end of season visit will be distributed at the time of the end of season visit. Participants with influenza-like illness, who attend an illness visit will be given $10 (check or pharmacy coupon) at the time of the illness visit, to purchase relief medications of their choice.

Enrollment Appointments...

To make an enrollment appointment,

in Ann Arbor, call (734) 615-8331 or toll free (877) 452-0012.
in Kalamazoo, call (269) 365-3833.
in Mount Pleasant, call (989) 774-4446 or toll free (800) 819-7850.
in Ypsilanti, call (734) 487-3065.

(Click any of the above city links for study center locations.)

Study centers are available in Ann Arbor, Kalamazoo, Mount Pleasant and Ypsilanti for enrollment and participation of interested persons.

A study center is open in the UM School of Public Health (SPH) building II, Room M5157 (Fifth Floor), 1420 Washington Heights. Parking is limited to metered street parking and nearby pay, deck parking in the Taubman Structure, located on E. Medical Center drive, just northeast of the School of Public Health building I. For more information, see UM parking map.

For those in the Kalamazoo area, a study center is in the Western Michigan University Sindecuse Health Center located on Gilkison St. in the center of campus. Parking is limited.

For those in the Mount Pleasant area, a study center is in the Central Michigan University Health Service in 104 Foust Hall, located on Preston St. just west of East Campus Dr. Parking is limited to metered street parking.

For those in the Ypsilanti area, a study center is in the Eastern Michigan University Snow Health Service just off East Circle Drive (building 30 on below map). Parking is limited. For more information, see the EMU building locator.

Influenza surveillance update... Earth Icon

For those interested, influenza surveillance information is posted by the Center for Disease Control (CDC).

This page was last updated on July 11, 2007.

fluvacs@umich.edu