Participants sought for experimental flu vaccine trial
BY ROSANNE SPECTOR
Cornelia Dekker
Researchers at the Stanford University School of Medicine are recruiting participants for a clinical trial to study the immune response to an experimental, seasonal DNA flu vaccine and boosted by one of two licensed seasonal flu vaccines, which are given either into the skin or into the muscle of the upper arm.
The trial’s immediate goals are to test the safety of the experimental DNA vaccine given alone or at the same time as the licensed vaccines, and to assess the immune responses they produce. The ultimate goal of the trial, sponsored by the National Institutes of Health, is to learn more about how to safely improve the immune response to seasonal flu vaccines.
“Currently available flu vaccines are good but they leave room for improvement and they have to be given every fall before the new flu season,” said Cornelia Dekker, MD, professor of pediatrics and medical director of the Stanford-LCPH Vaccine Program. “The holy grail for influenza researchers would be a vaccine that covers all influenza strains, including future pandemic ones, with just one injection.”
Every so often, a new type of influenza virus evolves that is different enough from past viruses that the population does not have immunity. In this situation, called a pandemic, the influenza virus rapidly spreads around the world. The pandemic in 1918 is estimated to have killed 50 million people. A successful universal influenza vaccine might help us avoid such a global disaster, Dekker said.
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Currently approved seasonal flu vaccines are made using either inactivated virus given as an injection, or weakened live virus given as a nasal spray. The DNA vaccine is a new approach, using DNA that has been genetically engineered to produce a single, specific protein from each of the three influenza virus types included in the vaccine formulation. The DNA is injected using a needle-free device into the muscle of the upper arm, where the cells’ genetic machinery follows the DNA instructions to make the virus proteins. The body recognizes the proteins as foreign and mounts an immune response that includes not only flu-specific antibodies, as with traditional vaccines, but also a cellular immune response.
“While the DNA approach may not get us all the way there, the combination of that technology plus a chance to investigate how additional injection into the skin vs. muscle affects the response should provide valuable information to guide next steps in development of an improved influenza vaccine,” she said.
The NIH’s Vaccine Research Center first began studies of the DNA vaccine for influenza in 2006. Since then, more than 300 adults have received the center’s influenza DNA vaccines in eight different studies. More than 2,100 additional adults have received other types of the center’s DNA vaccines in 27 different studies for diseases such as HIV, Ebola, Marburg, SARS and West Nile.
The flu vaccine research study will be conducted in 330 participants at four research centers in the United States, with up to 100 of those at Stanford. Participants will be randomly assigned to receive any combination of DNA vaccine and/or seasonal flu vaccine (given either into the skin or into the muscle of the upper arm), and then be given a booster of the same type of licensed seasonal flu vaccine in the fall of 2013 with the new formulation. The study will last 68 weeks for participants not yet enrolled and will include six clinic visits and two phone calls. The researchers will analyze participants’ blood samples to assess the amount of antibodies specific to the influenza viruses and will explore their T-cell responses to the influenza strains.
Participants must be healthy individuals between the ages of 18 and 64 who have the ability to visit Stanford University Medical Center and have not yet received a flu shot this year. Prospective participants can learn more online at http://vaccines.stanford.edu/clinical_trials.html#DNA_Vaccine. Information can also be requested by phone at (650) 498-7284 and by email at Vaccines_Program@stanford.edu. Participants will receive $30 for each non-vaccination clinic visit completed, and $60 for each vaccination visit completed.
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