NIAID 2009 H1N1 Influenza Research Program
NIAID support for influenza research over the past several years has greatly enhanced our preparedness for a pandemic influenza. The outbreak of the 2009 H1N1 influenza (swine flu) was unexpected; however, scientists in NIAID laboratories as well as NIAID grantees and contractors around the world have been studying diverse influenza viruses and are working to prepare for seasonal as well as pandemic influenza outbreaks.
Research on how influenza viruses replicate, interact with their hosts, stimulate immune responses, and evolve into new strains has created opportunities for new and improved design of influenza vaccines, diagnostic tools, and anti-influenza drugs. The research findings are applicable to seasonal epidemic and pandemic strains alike.
Basic Research
When news of the emergence of 2009 H1N1 influenza first broke, NIAID immediately began research on the virus in cell culture and in laboratory animals to identify the unique characteristics of the 2009 H1N1 virus. Read more about 2009 H1N1 influenza research in NIAID labs.
NIAID-supported work includes research to better understand the biology of influenza viruses. For example, researchers are studying the evolution, adaptation, and pathogenesis of swine influenza viruses as well as how influenza viruses are transmitted between animals, from bird to swine or from swine to swine, from animals to human and between humans.
At the NIAID Centers of Excellence for Influenza Research and Surveillance (CEIRS), scientists conduct influenza surveillance in animals and study influenza pathogenesis and the host response to the influenza virus. Included in this research is domestic and international surveillance to collect, identify, and sequence the genomes of influenza viruses circulating in wild and domestic swine. Read more about the NIAID CEIRS.
NIAID anticipates that these efforts will rapidly yield important information about which animals the virus can infect, the mechanisms by which the virus causes disease, the molecular signatures that indicate how virulent a virus strain may be and the major viral and host factors important in mounting an immune response to the virus.
Diagnostics
Quick and accurate tests for the diagnosis of an influenza infection are important for slowing the spread of the virus. Diagnostic tests are also important to help identify people who may have been infected with the 2009 H1N1 virus from people with other conditions who symptoms present like influenza. Rapid diagnostics also help to maximize the efficiency with which antiviral medications, such as those stored in the Strategic National Stockpile, are used.
NIAID has been developing diagnostic platforms capable of rapidly identifying a wide variety of pathogens in clinical samples, including specific subtypes of influenza, and the Institute is now working to accelerate development of these platforms to provide improved diagnostics for 2009 H1N1. Read more about a diagnostic tool called the Flu Chip.
Antiviral Therapies
Antiviral medications are an important counterpart to vaccines as a means of controlling influenza and for treating infection after it occurs.
Although the currently circulating 2009 H1N1 virus is sensitive to oseltamivir (Tamiflu) and zanamivir (Relenza), experience tells us that resistance to influenza antiviral medications frequently emerges. Indeed, over the past two years the circulating seasonal H1N1 influenza viruses have become oseltamivir-resistant, even while other influenza viruses have remained sensitive to the drug.
In recent years, NIAID has been working to develop and test the next generation of influenza antivirals. Three drugs are now in clinical trials, including a long-acting neuraminidase inhibitor, an inhibitor of the enzyme that replicates viral genes, and a drug that prevents the virus from entering human lung cells. NIAID will soon begin to evaluate how well these candidate antiviral drugs block the 2009 H1N1 strain and to screen other compounds for activity against the virus.
Vaccine Research
There are currently two types of licensed vaccines for prevention of influenza in the United States, inactivated vaccines that are based on chemically killed influenza viruses and injected intramuscularly; and live, attenuated vaccines that are based on a weakened influenza virus engineered to contain the genes of proteins, hemagglutinin and neuraminidase, of a circulating influenza strain and are given as a nasal spray.
The first step in creating both kinds of these vaccines for the 2009 H1N1 virus is the development of virus reference strains suitable for use in manufacturing. Once reference strains have been developed, they will be distributed to licensed manufacturers who will begin the process of producing limited quantities of vaccine known as pilot lots.
These pilot lots must be tested in clinical trials in humans before they can be approved for use by the FDA. The NIAID Vaccine and Treatment Evaluation Units (VTEU) will be used to quickly evaluate pilot lots of vaccine candidates to determine whether the vaccine is safe, induces protective immune responses, and the appropriate dose and number of dosages is determined. Read more about the NIAID VTEUs.
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