Vanderbilt University Medical Center is recruiting volunteers to participate in a national study of an investigational vaccine against the H7N9 influenza virus, also known as “bird flu.”
This is one of two Phase 2 studies currently being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to test the safety of the investigational vaccine and its ability to cause an immune response.
Bird flu epidemics have occurred each year in China since the first human cases were reported in that country in 2013. No human cases have been reported in the United States. But in the epidemics reported in China to date, 39 percent of those infected died.
Currently H7N9 is not spread through person-to-person transmission but in rare cases can arise through direct exposure to infected poultry or contaminated environments. However, if the virus mutates and becomes easily transmissible between humans, it could create a worldwide pandemic.
“As we see every year with seasonal flu and periodically with bird flu, influenza is constantly changing. Our job is to stay one step ahead of it,” said Buddy Creech, MD, MPH, director of the Vanderbilt Vaccine Research Program and principal investigator for the VUMC trial.
“Over the last few years several new vaccines have been developed to stop bird flu,” Creech added, “but as flu changes so does the need to change the vaccine.”
The study will test the experimental A/H7N9 inactivated influenza vaccine developed by Sanofi Pasteur.
The vaccine will be given with an additive (adjuvant) designed to further boost the immune response and in combination with the seasonal flu vaccine to healthy adults age 19 to 64 who have not been vaccinated this year. The adjuvant, AS03, is produced by GlaxoSmithKline Biologicals.
Volunteers will receive two doses of vaccine and will be monitored for seven days following each vaccination to assess any side effects. Blood samples will be tested for antibodies to the 2017 H7N9 virus and seasonal influenza. Volunteers will be followed for up to a year after their last vaccination.
VUMC began enrolling volunteers last month under NIAID contract number HHSN272201300023I. For more information about the current trial, visit ClinicalTrials.gov using the identifier NCT03318315.
Those interested in learning more about the VUMC trial should contact the Vanderbilt Vaccine Research Program at vaccineresearch@vanderbilt.edu.
VUMC participated in a previous H7N9 bird flu vaccine trial in 2013 as part of the NIAID-funded Vaccine and Treatment Evaluation Unit (VTEU) network.
That trial and other studies found that H7N9 vaccines made from inactivated viruses were safe and generated an immune response. However, since that time the virus has evolved and the previous vaccine is not as effective as it needs to be to protect people should human-to-human transmission begin to occur.