Health officials are calling for 1,700 healthy adult volunteers to enroll in a study of an experimental vaccine to fight bird flu (H7N9 avian influenza), according to the National Institutes of Health (NIH).
Bird flu (H7N9) was reported in China last April. Since August, the World Health Organization confirmed H7N9 was responsible for 135 infections and 44 deaths. Most cases involved people who came into contact with poultry.
So far, reports of H7N9 are primarily in China. According the NIH, the virus does not easily jump from person-to-person.
However, the health agency is concerned that the virus could mutate into a more problematic virus.
"H7N9 avian influenza virus...has the potential to cause widespread sickness and mortality," said Director Anthony S. Fauci, M.D at the National Institute of Allergy and Infectious Diseases (NIAID), a department of the NIH.
"We are now testing a vaccine candidate with and without adjuvant in an effort to prepare for and, hopefully, protect against this possibility."
A vaccine adjuvant is a substance that is added to the vaccine to increase the body's immune response to the vaccine.
The possibility of an H7N9 outbreak in the U.S. is enough to warrant a financial commitment of $135 million annually from the NIH. The money will go to a network of nine centers in cities throughout the U.S. Collectively, the centers are called Vaccine and Treatment Evaluation Units (VTEU).
"The VTEUs have been an invaluable resource for testing important vaccines and treatments against deadly emerging infectious disease threats," said Dr. Fauci. "The VTEUs have proved that they can rapidly enroll large numbers of participants.
"This agility is especially important for testing vaccines designed to counteract emerging infectious diseases of public health concern."
The study is comprised of two separate clinical trials. Together, the trials will enroll 1,700 healthy adults between the ages of 19 and 64 years old. A panel of independent experts will monitor safety throughout the trial, according to the NIH.
The H7N9 clinical trials are designed to gather information about:
- safety of the candidate vaccine
- immune responses at different doses
- effects of adjuvants
Two different adjuvants will be tested along with the H7N9 vaccine itself. Those adjuvants include:
- MF59 adjuvant, developed by Novartis Vaccines and Diagnostics
- AS03 adjuvant, developed by GlaxoSmithKline Biologics
The H7N9 clinical trials will be conducted in the following cities:
- Houston, Texas
- Cincinnati, Ohio
- Durham, North Carolina
- Atlanta, Georgia
- Seattle, Washington
- Saint Louis, Missouri
- Iowa City, Iowa
- Baltimore, Maryland
- Nashville, Tennessee
To enroll in the H7N9 avian influenza vaccine clinical trials
- ClinicalTrials.gov and use the following identifiers: NCT01938742 and NCT01942265.
- Email email@example.com
- Call (866) 833-5433
- For general information about the flu, see NIAID Influenza Web portal or Flu.gov.
- For additional other available vaccine trials, see VRC Vaccine Research Studies.
- To report side effects of vaccines, see Vaccine Adverse Event Reporting System.
- For information about vaccine injury compensation, see National Vaccine Injury Compensation Program.