URMC Enrolling Subjects to Test H7N9 Pandemic Bird Flu Vaccines
October 14, 2013
URMC researchers are recruiting 48 participants for an isolation-style study testing live-virus bird flu vaccines later this fall.
The project will test two different schedules of nasal vaccine and boosters, hoping to shed light on which approach does a better job priming the immune system against H7N9, a new strain of bird flu identified in China in April this year.
“In a pandemic, time is of the essence,” said study investigator John Treanor, M.D., an internationally known flu expert who heads the University’s Vaccine Research Unit. “While no cases of H7N9 have yet been identified in the U.S., the Centers for Disease Control is following the situation closely and taking precautionary action, developing and testing a candidate vaccine in case it was ever needed.”
For the study, participants will be assigned to one of two groups. The first will receive intranasal vaccine (containing a live, weakened version of the H7N9 virus) and spend 12 days in a local isolation facility. Several weeks later, they would receive a booster shot of inactivated H7N9 in an outpatient setting.
The second group would follow a similar schedule, but would receive an additional dose of intranasal vaccine—requiring an additional 12-day isolation stay—just 28 days after the initial dose. Then, several weeks later, they also would receive a booster of live, inactivated H7N9 in an outpatient clinic.
Scientists in the lab will watch how strongly each of the two vaccine schedules triggers the production of protective proteins, called antibodies, in participants. Treanor and his team hope that the findings will shed light on whether one schedule or the other produces more favorable immune response—information that could guide CDC officials charged with shaping clinical recommendations in the face of a pandemic.
The research is funded by the National Institutes of Health, using experimental vaccines manufactured by MedImmune (makers of seasonal FluMist®) and Sanofi.
Volunteers must be between 18 and 49, in good health, not pregnant, not asthmatic, and not allergic to eggs. Volunteers who have participated in previous avian flu vaccine trials will not be eligible; participants must agree to not travel to the southern hemisphere in the two weeks prior to their initial vaccination.
During the trial, all participants will receive one or two doses of H7N9 vaccine at the group’s isolation unit at Unity’s St. Mary’s campus, where they’ll be required to stay for 12 days (or two 12-day stays, if receiving two doses) as they have their health monitored and their blood drawn. For their time, participants who complete all study components will be paid between $2,475 and $3,990, depending on how many live vaccine doses/isolations stays are completed.
To see if you qualify for a study screening (involving a mini-physical, health questionnaire, and blood work), please call 585-273-3990 or fill out this form.