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Wits RHI

BEATRIX Study (C1091009)

Project Title

Beatrix Study (C1091009): Maternal Vaccine to Prevent Group B Streptococcus in Infants

Overview

The Beatrix Study is a Phase 3 clinical trial evaluating the safety, tolerability, and immune response of a Group B Streptococcus (GBS) vaccine (GBS6) administered during pregnancy. The study aims to determine whether vaccinating pregnant women can protect newborns and young infants from invasive GBS disease, a leading cause of serious infection in early life.

Rationale

Group B Streptococcus (GBS) is a major cause of severe infection, sepsis, and meningitis in newborns, particularly in the first months of life. Despite existing prevention strategies, such as antibiotics during labour, significant gaps remain especially in low-resource settings where access to these interventions is limited. Research has shown that:

  • Higher levels of maternal antibodies against GBS are associated with reduced risk of infection in infants
  • These protective antibodies can be transferred from mother to baby during pregnancy

The GBS6 vaccine has been developed to target the six most common GBS strains globally, with the aim of preventing both early- and late-onset disease in infants. This study seeks to:

  • Confirm the safety of the vaccine in pregnant women and their infants
  • Evaluate whether vaccination can generate protective antibody levels in newborns
  • Support the development of a maternal immunisation strategy to prevent GBS disease worldwide

Primary Objectives

  • Assess the safety and tolerability of the GBS6 vaccine in pregnant women
  • Evaluate infant safety outcomes following maternal vaccination
  • Determine predicted vaccine effectiveness based on protective antibody levels in infants at birth

Secondary Objectives

  • Further evaluate immune responses in pregnant women and infants
  • Measure antibody transfer from mother to baby
  • Explore the impact of maternal vaccination on infant responses to routine vaccines
  • Assess GBS colonisation and antibody presence in breast milk

Investigators

  • Prof Lee Fairlie – Principal Investigator
  • Dr Mrinmayee Dhar – Sub-Investigator
  • Dr Faeezah Patel – Sub-Investigator
  • Dr Jeanne Coetzee – Sub-Investigator
  • Dr Elizea Horne – Sub-Investigator
  • Tiffany Deborah Seef – Clinical Associate
  • Karabo Busisiwe Tloubatla – Clinical Associate

Latest Updated: April 2026

For more details about the Beatrix Study (C1091009) please email rhicomms@wrhi.ac.za

Project Brief

Project Brief BEATRIX Study (C1091009)