GBS6 Vaccine Study

A phase 1/2, randomized, placebo-controlled, observer-blinded Trial to evaluate the safety, tolerability, and immunogenicity of a multivalent group b streptococcus vaccine in healthy non pregnant women and pregnant women 18 to 40 years of age and their infants.

Rationele

  • Among young infants, GBS is a leading cause of invasive bacterial infection, a significant cause of infant morbidity and mortality globally. Serious GBS disease, including sepsis, meningitis, and pneumonia, is associated with mortality rates of 6% to 14% in high-income countries and 10% to 60% in low- and middle-income countries (LMICs).
  • Vaccination of pregnant women has been used globally in the prevention of neonatal tetanus and more recently for prevention of pertussis in young infants, and to protect women and their infants against influenza.
  • Pfizer is developing a 6-valent capsular polysaccharide (CPS) conjugate vaccine (group B streptococcus 6-valent polysaccharide conjugate vaccine [GBS6]) aimed at the prevention of group B streptococcal disease due to 6 serotypes in young infants by active immunization of pregnant women.

Primary Objectives

Stage 1:

  • To describe the safety and tolerability of various GBS6 formulations in healthy nonpregnant women 18 to 40 years of age.

Stage 2

  • To describe the safety and tolerability of various GBS6 formulations when administered to healthy pregnant women 18 to 40 years of age vaccinated at 27 to 36 weeks’ gestation.
  • To assess the safety of maternal immunization in infants born to women who were vaccinated with various GBS6 formulations during pregnancy.

Stage 3

  • To describe the safety and tolerability of 1 selected dose/formulation of GBS6 when administered to healthy pregnant women 18 to 40 years of age vaccinated at 27 to 36 weeks’ gestation.
  • To assess the safety of maternal immunization in infants born to women 18 to 40 years of age who were vaccinated with 1 selected dose/formulation during pregnancy.

Study Population

Women

Invetigators

  • Dr Lee Fairlie, Principal Investigator
  • Dr Masebole Masenya, Sub Investigator
  • Dr Faeezah Patel, Sub Investigator
  • Dr Elizea Horne, Sub Investigator

Donor

Pfizer

Latest Update: 15 February 2021

For more about GBS6 Vaccine Study please email rhicomms@wrhi.ac.za