Via European Pharmaceutical Review: H7N9 influenza vaccine clinical trials begin. Excerpt:
Two new clinical trials testing an experimental vaccine to prevent influenza caused by an H7N9 influenza virus are now enrolling volunteers at sites across the United States.
The Phase 2 studies, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will test different dosages of the inactivated influenza vaccine candidate (called 2017 H7N9 IIV) as well as different vaccination schedules. The studies also will evaluate whether an adjuvant boosts the immune responses of people receiving the vaccine.
No human cases of H7N9 influenza have been detected to date in the United States. Currently, the virus does not spread easily from person to person; rather, people typically become infected through direct exposure to infected poultry or contaminated environments. However, if the virus mutates and becomes easily transmissible between humans, it could result in an influenza pandemic because most people have little to no immunity to it. H7N9 has a high mortality rate, resulting in death in 39 percent of those who became infected.
“As we experience one of the worst seasonal influenza epidemics in recent years here in the United States, we also must maintain a scientific focus on novel influenza viruses, such as H7N9, that have the potential to cause a pandemic,” said NIAID Director Dr Anthony S. Fauci, “These new clinical trials will build upon initial studies of earlier versions of an H7N9 vaccine candidate to provide a more detailed picture of its safety and ability to generate a protective immune response to current H7N9 strains.”
The two clinical trials will test the experimental 2017 H7N9 inactivated influenza vaccine developed by Sanofi Pasteur, based in Lyon, France, supported by the Biomedical Advanced Research and Development Authority (BARDA), a component of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. NIAID funded previous research on the earlier version of the vaccine.
The new version of the vaccine candidate uses an inactivated form of H7N9 influenza virus collected in 2017, to increase the likelihood that the vaccine will provide immunity against a newly-evolved strain of H7N9, which is currently circulating in the wild.
During these clinical trials, some participants will receive an adjuvant, called AS03, along with the test vaccine, to confirm that the adjuvant can boost the immune response to the vaccine, as previously shown for other influenza viruses of pandemic potential. The adjuvant is produced by GSK’s vaccines business, headquartered in Wavre, Belgium, with support from BARDA. Both clinical trials will be conducted by the NIAID-funded network of Vaccine and Treatment Evaluation Units (VTEUs).
