URMC Receives $15.5M for Live Virus Vaccine Isolation Studies
This week, the University of Rochester Medical Center (URMC) announced plans to begin a cluster of bird flu vaccine trials, many of which will contain live, weakened viruses and require participants to remain in isolation for several days a time. Slated to start this summer, the studies are funded by a National Institutes of Health grant amounting to more than $15.5 million over five years.
Because the U.S. Food and Drug Administration (FDA) has not yet approved the vaccines, research subjects would be quarantined in URMC’s new Vaccine Research Isolation Unit to reduce any hypothetical risk of transmitting the virus to the general public. Historically, similar trials have been conducted in hotels, but URMC’s new isolation space – thanks to an agreement to lease an unoccupied floor of Unity St. Mary’s Campus – affords a more “permanent” and clinically appropriate research setting. URMC hopes to conduct about five trials a year in the new space, which features smoke-free, dormitory-style private rooms equipped with internet access, televisions and windows.
For the first study, scientists are seeking nearly two dozen adults to receive an investigational bird flu vaccine and spend at least 12 days on the isolation unit. Developed by the National Institute of Allergy and Infectious Disease, the vaccine primes the body to fight a strain of bird flu known as H7N3, and was well-tolerated and produced a fair immune response in humans who received two doses of it in a 2007 Johns Hopkins trial. Picking up where Hopkins’ research left off, this Rochester trial seeks to learn if a single dose is safe and sufficient to trigger a protective germ-fighting response – a critical next hurdle before the vaccine can secure FDA endorsement.
H7 Viruses, Public Threat?
H7 influenza viruses (strains of flu are named for the different protein coats they “wear”) typically infect birds. Only recently have they become more problematic for humans, said URMC flu expert John Treanor, M.D., who serves as the new grant’s principal investigator and as chief of URMC’s Infectious Disease Division.
“The first H7 virus we’ll study has sickened people in Canada, Italy, the UK and the Netherlands,” he said. “While in most cases those who were infected only had mild symptoms, like red or watery eyes, flu is known for its power to morph. We simply can’t predict how severe these infections might prove in the future.”
No licensed vaccine is currently available to protect people against this particular stain of bird flu. Thankfully, while H7 viruses can occasionally spread from birds to humans, they’ve not yet acquired the ability to then jump from human to human – the “X-factor” that elevated last year’s H1N1 swine flu situation to pandemic proportions.
“If the virus were to become transmissible between humans, we’d have a lot of illness – maybe mild, maybe not – on our hands, just like we saw with H1N1 flu last year,” he said. “That’s another reason we’re so interested in seeing if a single dose is protective; in the throes of a pandemic, there are big logistical and manufacturing advantages if you can achieve a healthy immune response with less product.”
The investigational vaccine to be tested in this first isolation trial is similar to FluMist, the licensed nasal spray vaccine for seasonal flu, except that it contains two genes that help it mimic the H7N3 strain.
To participate, study volunteers must be between 18 and 49 years old and must not be pregnant, have an allergy to eggs, or have another medical condition that compromises their immune system and thereby would make live-virus vaccinations unsafe. If selected, study volunteers must stay a minimum of 12 days (two days before receiving vaccine, or “day -2” and “day -1;” the day of the vaccine, or “day 0;” and at least nine days following the vaccine, “day 1” through “day 9”). While on the unit, they will undergo daily physical examinations (e.g., vital signs) and nasal washes (to see how long the weakened virus remains in the nasal cavity, where vaccine is initially sprayed), and provide several blood samples. To be discharged, volunteers must go two consecutive days (after day 7) with no febrile or flu-like symptoms, including a negative nasal culture. Three separate outpatient follow-up visits, each requiring a nasal wash and blood sample, will be scheduled for one, two and six months after initially receiving vaccine. (Note: As part of this study and/or other studies linked to this new grant, URMC will partner with colleagues at Dartmouth who will help analyze samples to gauge participants’ immune responses.)
Volunteers could receive up to $2,025 for completing this study – including a $50 honorarium for a screening visit, $125 per day spent on the isolation unit, $75 per follow-up outpatient visit, and a $250 bonus for completing all study visits on time. As the isolation unit does not offer cooking facilities, food and beverages will be provided.
For further information or to enroll, please call the Vaccine Research Unit at (585) 273-3990.