Pfizer has commenced a Phase l/ll study of its unnamed respiratory syncytial virus (RSV) vaccine candidate in healthy adult subjects.
RSV is a common respiratory virus that affects the lungs and airways, as well as significantly impacts young children and older adults.
The randomised, placebo-controlled, observer-blind, dose-ranging trial will enrol subjects in two age groups in parallel to support both the maternal and older adult indications.
One of the groups will comprise males and females between the ages of 18 and 49, while the other group will include males and females aged 50 to 85 years.
The trial’s primary objectives are safety and tolerability, and its secondary objective is immunogenicity.
The trial principal investigator Edward Walsh said: “RSV is the most frequent cause of serious respiratory tract infection in infants and young children, and also significantly impacts older adults and those with a compromised immune system.
“There is an urgent global need to develop a safe and effective vaccine as a preventative option to reduce the incidence and severity of this infection in these populations.”
The existing prophylactic treatments for RSV can only be used in high-risk young children and infants, including very premature infants.
With its investigational RSV vaccine, Pfizer expects to provide immunity to young infants by vaccinating pregnant women, and older adults through direct vaccination.
The vaccine candidate is based on foundational basic science discoveries, including those made at the US National Institutes of Health (NIH), which featured the crystal structure of a major viral protein that RSV uses to attack human cells.