Two Phase II clinical trials have started enrolling participants across the US to test an experimental inactivated influenza vaccine, 2017 H7N9 IIV.
Developed by Sanofi Pasteur, the vaccine candidate is intended to prevent infection from the bird influenza virus H7N9, which was first reported in humans in China in 2013.
The trials will evaluate various dosages of the vaccine, vaccination schedules and the candidate’s effect on immune responses when given in combination with GlaxoSmithKline’s AS03 vaccine.
The trials are funded by the National Institute of Allergy and Infectious Diseases (NIAID) division of the National Institutes of Health. The NIAID-funded network of vaccine and treatment evaluation units (VTEUs) will perform both of the trials.
NIAID director Anthony Fauci said: “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 new version of the vaccine candidate uses an inactivated form of the H7N9 influenza virus collected in 2017 to increase the likelihood of the vaccine providing immunity against a newly-evolved strain of H7N9.
The first of the trials will be conducted at VTEU sites in Georgia, Iowa, Maryland, North Carolina and Washington, where 420 participants aged 19-64 and 300 participants over 65 will be recruited.
The volunteers will receive two vaccinations of 2017 H7N9 IIV either with or without the AS03 adjuvant.
Set to take place in Alabama, Maryland, Ohio and Tennessee, the second trial will recruit 150 healthy individuals aged 19-64. The trial will test a combination of the vaccine candidate, AS03 adjuvant, and a quadrivalent seasonal influenza vaccine.
In this trial, investigators intend to evaluate whether the H7N9 vaccine candidate affects the immune response to the seasonal influenza vaccine, and vice versa.
Subjects in both the trials will be monitored for seven days after each vaccination and followed-up for around one year.