Children’s is one of nine centers nationwide taking part in clinical trials
testing in humans an investigational H7N9 avian influenza vaccine.
The two concurrent
Phase II clinical trials, sponsored by the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of Health, will
compare safety and strength of immune system responses when administered at
different dosages and with or without adjuvants, substances designed to boost
the body’s immune response to vaccination.
Children’s is participating in the studies as one of just eight NIAID-funded
Vaccine and Treatment Evaluation Units in the United States. A ninth center is
serving as a subcontractor.
Human cases of
H7N9 influenza first emerged in China in February 2013, with the majority of
reported infections occurring in the spring. As of Aug. 12, 135 confirmed human
cases, including 44 deaths, have been reported by the World Health
Organization. Most of these cases involved people who came into contact with
infected poultry. Although no H7N9 influenza cases have been reported outside
of China, and the virus has not demonstrated sustained person-to-person
transmission, there is concern that it could mutate to pose a much greater
public health threat.
“Although the virus
has not been detected in the United States and is not easily spread between
people, we are concerned the virus might change so that it spreads rapidly,”
says David Bernstein, MD, an infectious diseases physician leading the studies
at Cincinnati Children’s. “Therefore, we need to be prepared with a
vaccine to protect people; we’d rather be safe than sorry.”
The two clinical
trials, which will enroll healthy adults ages 19 to 64, will evaluate an
investigational H7N9 vaccine developed by Sanofi Pasteur. The candidate vaccine
was made from inactivated H7N9 virus isolated in Shanghai, China in 2013.
Adjuvants are being tested with the investigational vaccine because previous
vaccine research involving other H7 influenza viruses has suggested that two
doses of vaccine without adjuvant may not produce an immune response adequate
to provide effective protection.
situations, adjuvants also can be used as part of a “dose-sparing” strategy,
which would allow production of more doses of vaccine from the available supply
of the viral antigen, thereby allowing a greater number of people to be
vaccinated more quickly.
In both studies,
which are expected to conclude in December 2014, a panel of independent experts
will closely monitor safety data at regular intervals throughout the trial.
The vaccine studies
are being conducted at the eight NIAID-funded Vaccine and Treatment Evaluation
Units: Baylor College of Medicine, Houston; Children’s Hospital Medical Center,
Cincinnati; Emory University, Atlanta; Group Health Cooperative, Seattle; Saint
Louis University, St. Louis; University of Iowa, Iowa City; University of
Maryland School of Medicine, Baltimore; and Vanderbilt University, Nashville.
Additionally, the University of Texas Medical Branch at Galveston will be
conducting the trial as a subcontractor to Baylor College of Medicine.
about the trials can be found at ClinicalTrials.gov using the identifiers NCT01938742 and NCT01942265.
To learn more about
participating in the studies at Cincinnati Children’s, all the study line at 513-636-7699
or email firstname.lastname@example.org.