“It is difficult to predict whether the H7N9 virus will cause a pandemic, but there is great concern that the H7N9 virus may gain the ability to transmit easily from person-to-person. If that happens, then rapid spread around the world could occur, as almost all people are susceptible to the virus. If a pandemic develops, then we need to be prepared to deliver effective vaccines rapidly to the entire population,” says Dr. Wendy Keitel, the principal investigator of the BCM VTEU and a member of the BCM Vaccine Research Center.
Funded by the National Institutes of Health, the study being conducted at Baylor will recruit up to 1,000 adults nationally who are 19 to 64 years old and in good health. Study participants will receive different dosages of an investigational vaccine given with or without one of two adjuvants, which are substances added to a vaccine to increase the body’s immune response. Researchers at each site will gather safety information, risks and benefits of vaccinations and the effectiveness of the vaccines to trigger an immune response.
“We are grateful to the members of our community for their willingness to participate in research studies,” Keitel said. “This H7N9 clinical trial will provide critical information about what it will take to stimulate immune responses that could protect against infection or disease caused by this and related viruses. Without gathering such information before a potential pandemic, precious time would be lost as the virus spreads around the world.”
The new avian influenza strain was first detected in China last spring. More than 130 people, most of whom had contact with poultry, were diagnosed with the illness and suffered from severe respiratory infections. Forty four people died. While most of those stricken with the H7N9 flu were adults, four cases were confirmed in children.
Health authorities are preparing for possible H7N9 flu re-emergence during the normal flu season when the weather turns cooler and for further virus mutation, making it more easily transmitted between people.
The spread of flu becomes a pandemic when people don’t have immunity to new strains and it spreads quickly. The last pandemic occurred in 2009 with the spread of swine H1N1 influenza, which originated in pigs and spread to people.
Fighting the virus
Vaccines are one of the most effective ways to protect against the flu. They work by triggering the body’s immune response by making antibodies that fight the flu virus. Those who are vaccinated may not get sick or may have a much milder case of the illness.
Eight VTEUs, which are funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, will participate in trials to investigate an experimental H7N9 influenza vaccine. In addition to the BCM VTEU, other sites include Saint Louis University, St. Louis; Children’s Hospital Medical Center, Cincinnati; Emory University, Atlanta; Group Health Cooperative, Seattle; University of Iowa, Iowa City; University of Maryland, Baltimore; and Vanderbilt University, Nashville. Additionally, the University of Texas Medical Branch in Galveston will be conducting the trial as a subcontractor to Baylor College of Medicine.
Further information about both clinical trials can be found at ClinicalTrials.gov using the identifiers: NCT01938742 and NCT01942265.
For more information on how to take part in the H7N9 study, please contact the BCM Vaccine Research Center at 713-798-4912.