Flu vaccine clinical trials seek participants, especially kids

As flu season approaches, researchers at the Stanford University School of Medicine are seeking healthy people to participate in several clinical trials examining the immune system’s response to the influenza vaccine.

Researchers are especially interested in enrolling children between 6 months and 4 years old who have never received the flu vaccine, but children who have had the flu vaccine can also be enrolled. They also need children ages 5-13 and adults ages 18-30. In addition, the researchers are also looking for identical twins ages 2-5, as well as identical and fraternal twins ages 12-49.

All participants will receive the current flu vaccine approved by the U.S. Food and Drug Administration, and will be required to give a blood sample; some may also have nasal swabs taken. Participants will be compensated $30 for each clinic visit. Some participants will be asked to return again each year for up to five years.

Each biological sample donated may be used in many different experiments by Stanford researchers, said Cornelia Dekker, MD, professor of pediatrics and medical director of the Stanford-LPCH Vaccine Program.

“It’s a very detailed, deep dive into the immune response to influenza vaccines,” she said.

Dekker said that although flu vaccines have been extensively studied for their ability to generate antibodies, or compounds that label a virus as “foreign,” researchers now have the ability to use new technologies, including some developed at Stanford, to gain a more detailed understanding of the immune system.

“It’s like looking into a microscope and seeing the tiny grains of sand rather than just looking at the beach,” Dekker said. “The new assays really allow us to learn a lot and appreciate the fact the immune system is much more complex that we thought.”

How children respond

In particular, researchers are keen to explore how a child’s immune system responds when exposed to completely novel stimuli, such as a first flu vaccine, and how it develops over time, she said. This is why they are interested in enrolling children who will return for up to five years and report on factors such as infections, routine immunizations and child-care attendance that may influence age-related changes to the immune system.

Researchers are using nasal spray and hypodermic injections to deliver the vaccines, Dekker said. There’s a special high-dose formulation for elderly participants.

For the first time, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has recommended that healthy children ages 2-8 receive the nasal spray vaccine rather than a shot, if it is available and unless they suffer from asthma or other respiratory conditions, Dekker said.

All eligible children in that age group who enroll in the Stanford trials will receive the nasal spray vaccine.

For additional information on the trials and to sign up, visit http://vaccines.stanford.edu/clinical_trials.html.

Even if you choose not to participate in a clinical trial, it is important to vaccinate yourself and any children older than 6 months against the flu, Dekker said. Pregnant women should also receive flu vaccines to protect themselves and their babies until they can be immunized.

Other Stanford investigators leading the studies are Mark Davis, PhD, director of the Stanford Institute of Immunity, Transplantation and Infection, and a professor of microbiology and immunology; Harry Greenberg, MD, professor of gastroenterology and hematology and of microbiology and immunology; Garry Nolan, PhD, professor of microbiology and immunology; William Robinson, MD, associate professor of immunology and rheumatology; Stephen Quake, PhD, professor of bioengineering and of applied physics; and Atul Butte, MD, PhD, associate professor of systems medicine in pediatrics and of genetics.

The studies are funded by the National Institutes of Health.