Participants Needed for Investigational Flu Vaccine Study

Saint Louis University’s Center for Vaccine Development is conducting a study with an investigational flu vaccine.

Background

Infection with a flu virus is a major public health threat, because it is able to spread rapidly through populations and affect large numbers of people. It is responsible for about 36,000 deaths each year in the US. Many deaths occur among older people. Current flu vaccines protect older people against flu, but not as well as desired.

Study Information

This study is split into two parts. The first part (Part 1, which has already been completed), was to test four different doses of the flu vaccine, so that the right dose can be tested in this second part of the study (Part 2, that volunteers may be included in), in older adults.

The new flu vaccine contains an “adjuvant,” which is something that is mixed with the normal flu vaccine before it is given to a patient. This adjuvant helps the body to have a better immune response to the vaccine, so it is more likely to stop you getting flu. Volunteers who participate in this second part of the study receive either the adjuvanted vaccine dose picked in Part 1 or unadjuvanted, high-dose flu vaccine. The vaccine in this study has a new type of adjuvant; it is not yet approved for use by the Food and Drug Administration (FDA). The FDA approval process for the new flu vaccine starts with this study.

Key Points

• To participate, volunteers must be 65 years of age or older
• Participants cannot get the flu from the vaccine
• Participation is strictly voluntary
• A complimentary seasonal flu vaccine will be offered to all volunteers

Participants will be compensated for participating: $75 per visit and $10 per phone call
There are about eight visits and about two phone calls over approximately 12 months.

To discuss volunteering, contact a nurse at 1-866-410-6333 (toll free), email vaccine@slu.edu, or visit http://vaccine.slu.edu. Refer to study #311B , IRB #25821