Skip to content

RSV GRACE Study Conducted by Saltzer Research

23rd August, 2021 | Published by Saltzer Health

Grace Study

What is RSV?

  • Enveloped single-strand RNA pneumovirus within the Paramyxoviridae family
    – 2 main subgroups: A/B – antigenically related
  • In temperate climates, annual epidemics occur during winter
  • Circulation overlaps with seasonal influenza

Most common cause of ALRI in children <5 years, and a major cause of ALRI-associated hospitalisation

Who is most at risk of RSV?

  • Almost all children will have experienced an RSV infection by 2 years of age
  • Very young infants have the greatest risk of severe illness caused by RSV
  • The highest priority target population is the RSV-naïve child

There is currently no specific treatment or currently approved vaccine. The development of effective new vaccines … to tackle RSV have the potential to make major contributions to reducing severe disease and deaths from RSV in children globally.

What is GRACE study?

  • Phase 3 Global Clinical study
  • Approximately 10,000 pregnant women
  • Double-blind study
  • Single dose administered intramuscularly
  • Robust safety data is available from prior studies

What is the Purpose of the study?

  • Evaluate the ability of the vaccine in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers.
  • Evaluate the safety and immunogenicity of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant.

Who is eligible to take participate in the study?