URMC Enrolling Patients to Test Live Pandemic Flu Vaccines

Apr. 8, 2013
In Study, Scientists Learn to Sort ‘Dud’ Vaccines from Workable Ones

This spring, infectious disease researchers at URMC will recruit 20 volunteers for a 12-day isolation research study testing live-virus bird flu vaccines. Their hope: Turning up a “marker” of sorts that would let future scientists know – fast – which vaccines are likely to work, and which are bound to fail. 

“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. “Being able to develop, test, and bring an effective vaccine to the market faster, even a couple weeks sooner, could make a big difference in terms of lives saved and illness avoided.”

Compared to traditional flu shots, live-virus vaccines, squirted into the nose, have the potential to produce a more robust immune response; after all, they challenge the body to beat back real virus, not just pieces of a “dead” one. For a pandemic scenario, this makes them particularly attractive: It could mean fewer doses are needed to protect a population. The problem is that, while some live-virus vaccines absolutely flourish in the human nose, others fail to thrive.

“That’s important, because you need the virus to take root and start replicating first before the body can learn how to fight it,” Treanor said. “If we want to leverage these new vaccines in pandemic situations, we need to understand which ones grow best, and why.”

The upcoming study specifically looks at two strains of pandemic vaccine (H2N3 and H9N2) – one known to blossom in the nasal cavity, the other, not as much. Treanor’s team will be watching closely to see precisely how and why the “dud” vaccine fails.

To do that, scientists will be carefully studying blood samples from study volunteers, along with the occasional nose cells that stick around on nasal swabs, for clues. In the lab, they’ll closely inspect the cellular-level system response, to learn more about how cells go about manufacturing (or rather, not manufacturing) the kinds of proteins that actively defend against disease. Treanor and his team hope that, by better understanding what goes wrong, and when, they’ll be able to identify a marker of sorts – an early warning sign that a particular vaccine is doomed to flop.

Both study vaccines, given as nasal spray or drops, aim to protect against still-novel strains of pandemic flu, and contain live but weakened virus originating from birds. Today’s health care providers typically reserve nasal flu vaccines (only the seasonal variety is FDA-approved) for kids, since they work best in a naive immune system that hasn’t weathered the winter-after-winter barrage of flu germs. But Treanor says they’re also an exciting prospect for pandemic flu. After all, when it comes to pandemic viruses – which are highly contagious, in big part, because so few people have residual antibodies against them – everyone’s immune system is a “kid at heart.”

The upcoming study – a Cooperative Research and Development Agreement, or CRADA, a mechanism used by federal laboratories to engage in collaborative efforts with non-federal partners – is funded by the National Institutes of Health, with experimental vaccine donated by MedImmune, maker of seasonal FluMist®. URMC is the only institution in the country to trial this live, weakened pandemic vaccine technology.

To Participate

Volunteers must be between 18 and 42, in good health, not pregnant, and not allergic to eggs. During the trial, all participants will receive either vaccine against H2N3 or H9N2, or placebo, at the group’s isolation unit at Unity’s St. Mary’s campus, where they’ll be required to stay for 12 days as they have their health monitored and their blood drawn. For their time, participants are paid up to $1,710.

To see if you qualify for a study screening (involving a mini-physical, health questionnaire, and blood work), please call 585-273-3990.