GBS 6 Vaccine Study (C1091002)
A Phase 1/2 clinical trial has been designed as a randomized, placebo-controlled, observer-blinded study to assess the safety, tolerability, and immunogenicity of a multivalent group B Streptococcus (GBS) vaccine. This trial targets healthy nonpregnant women and pregnant women aged 18 to 40 years, along with their infants.
Rationale
GBS is a leading cause of invasive bacterial infection in young infants, contributing significantly to infant morbidity and mortality worldwide. The severity of GBS disease, such as sepsis, meningitis, and pneumonia, is linked to mortality rates ranging from 6% to 14% in high-income countries and 10% to 60% in low- and middle-income countries (LMICs).
Vaccination of pregnant women has been a global strategy, initially targeting neonatal tetanus and more recently expanding to include pertussis and influenza prevention for both women and their infants.
Pfizer is currently developing a 6-valent capsular polysaccharide (CPS) conjugate vaccine, known as the group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6), to prevent group B streptococcal disease caused by six specific serotypes in young infants. This Phase 1/2 study, which is randomized, placebo-controlled, and observer-blinded, marks the initial assessment of GBS6 in pregnant women for active immunization purposes.
Investigators
- Prof Lee Fairlie (Principal Investigator)
- Dr Faeezah Patel (Sub-Investigator)
- Dr Elizea Horne (Sub-Investigator)
- Dr Mrinmayee Dhar (Sub-Investigator)
- Dr Muneerah Khan (Sub-Investigator)
- Dr Jeanne Coetzee (Sub-Investigator)
- Tiffany Seef (Clinical Associate)
- Othusitse Segalo (Clinical Associate)
Latest Update:
March 2024
For more about GBS 6 Vaccine Study (C1091002) please email rhicomms@wrhi.ac.za
