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The purpose of the FLU-VACS research study is to compare the 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 names Fluzone or Fluvirin) which is given as an injection (“flu shot”), and the other is the new 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. We do not know whether these vaccines will work equally well, or whether one will work better than the other, for example, in terms of how long protection lasts. Our research study will help to determine how the vaccines will be used to control influenza outbreaks, and will contribute to future studies when the FluMist vaccine is tested in the elderly and those with chronic health conditions.

Briefly, the study is to go on for three years. In the first two years, participants will receive either one of the two licensed vaccines or a placebo (a preparation similar to the vaccines but with no active ingredients) during the fall (October or November) vaccination period. Which preparation you receive will be assigned by chance, but you will have an 83% chance of receiving one of the vaccines (5 out of every 6 participants will receive vaccine) and a 17% chance of receiving a placebo (1 out of every 6 participants will receive placebo). A blood specimen (10 ml or 2 teaspoons) will be collected when vaccine or placebo is given and then again 4 weeks later; this is to determine how your body has responded to the vaccine by producing antibodies, substances in the blood which fight infection. During the influenza season (November – April), you will be asked to report any respiratory illnesses and to come in to have a throat swab specimen collected if influenza is suspected. This specimen will be used to identify the cause of your illness. At the end of the influenza season in the spring (April or May), a third blood specimen will be collected.

In the third year, we will collect only two blood specimens, one before and one after the influenza season, and continue to follow participants for respiratory illness, but no vaccine or placebo will be given. This will be to determine if vaccine needs to be given each year.

1,980 persons are expected to participate; 83% (approximately 1,650) of participants will receive one of the two licensed influenza vaccines and 17% (approximately 330) will receive placebo. Participants will be enrolled at 6 study sites in Michigan.

Participants will be compensated for all study visits, including illness visits. Participants who complete the three annual study visits - enrollment/vaccination visit, follow-up visit and end of season visit – will receive at least $100 ($30 for the first two visits and $40 for the final visit; additional compensation ($25 per visit) will be received in the event of influenza-like illness with specimen collection (throat culture) for virus identification.