Flu Vaccine Study Seeks Volunteers
Saint Louis University’s Center for Vaccine Development is conducting a study with an investigational flu vaccine.
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.
This study is split into two parts. The first part has already been completed and was to test four different doses of the flu vaccine. Part 2 of the study will test to determine the right dosage in older adults. This second study part is seeking volunteers.
The new flu vaccine contains something called an “adjuvant,”which 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 a person from getting flu. 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.
Those participating in this second part of the study will receive either the adjuvanted vaccine dose that was previously determined in the study’s Part 1 or unadjuvanted high dose flu vaccine.
To participate and key points:
- A volunteer must be 65 years-old or older.
- A person cannot get the flu from the vaccine.
- Participation is strictly voluntary.
Study volunteers will be compensated for participating at a rate of $75 per visit and $10 per phone call.
There are about 8 visits and about 2 phone calls over approximately 12 months.
To discuss volunteering, please contact a nurse by phone at 1-866-410-6333 (toll free), by email or visit the Vaccine Center.
The Institutional Review Board study number assigned to this project is #311B and its protocol number if #25821. The study was approved on Aug. 1, 2017, and is under the direction of Geoffrey J. Gorse, M.D.
Refer to study # 311B , IRB # 25821.