WASHINGTON (Reuters) - Trials of the experimental new H1N1 swine flu vaccine will start at eight university medical centers and clinics next month, starting with vaccines made by Sanofi Aventis and CSL Ltd, U.S. health officials said on Wednesday.
The first round of tests will be in adults, but will quickly move to children, said Dr. Karen Kotloff of the University of Maryland, who will be leading one of the trials.
Although some vaccine manufacturers have complained that the H1N1 vaccine is not especially easy to make, Kotloff said there would be enough. “I have been told that there is sufficient vaccine to perform the studies,” Kotloff said in a telephone interview.
The trials, likely to begin on August 10, should also have no trouble enrolling volunteers, she said. “There is a great deal of interest,” she said.
H1N1 has caused the first influenza pandemic of the 21st century, spreading globally in just a few weeks and infecting millions.
It appears to act a little differently from normal seasonal influenza — causing severe sickness in younger adults and older children, as well as some of the usual high risk groups including pregnant women and people with asthma and diabetes.
It also appears to cause serious disease in the obese, although large studies have not confirmed this, and the elderly may have some immunity against it. But most of the population has little or no immunity against the new strain.
The first studies will look at whether one or two 15 microgram doses of H1N1 vaccine are needed to protect a healthy adults from influenza. Researchers will also test 30 microgram doses.
If less vaccine is needed to protect people, then more people can be vaccinated. It is not yet clear how many doses companies will be able to manufacture.
Researchers will also examine the safety and immune response in healthy adult and elderly volunteers who are given the seasonal flu vaccine along with a 15 microgram dose of 2009 H1N1 vaccine.
“If early information from those studies indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will start,” the National Institute of Allergy and Infectious Diseases, which will oversee the trials, said in a statement.
“These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall,” the institute’s director, Dr. Anthony Fauci, said in a statement.
Global health officials have said H1N1 vaccination campaigns can likely begin in October.
Editing by Mohammad Zargham