Advances towards licensure of a maternal vaccine for the prevention of invasive group B streptococcus disease in infants: a discussion of different approaches

ABSTRACT

Group B streptococcus (Streptococcus agalactiae, GBS) is an important cause of life-threatening disease in newborns. Pregnant women colonized with GBS can transmit the bacteria to the developing fetus, as well as to their neonates during or after delivery where infection can lead to sepsis, meningitis, pneumonia, or/and death. While intrapartum antibiotic prophylaxis (IAP) is the standard of care for prevention of invasive GBS disease in some countries, even in such settings a substantial residual burden of disease remains. A GBS vaccine administered during pregnancy could potentially address this important unmet medical need and provide an adjunct or alternative to IAP for the prevention of invasive GBS disease in neonates. A hurdle for vaccine development has been relatively low disease rates making efficacy studies difficult. Given the well-accepted inverse relationship between anti-GBS capsular polysaccharide antibody titers at birth and risk of disease, licensure using serological criteria as a surrogate biomarker represents a promising approach to accelerate the availability of a GBS vaccine.

KEYWORDS:

• GBS;invasive disease;infants;IAP;capsular polysaccharide;conjugate vaccine;maternal immunization;serocorrelate

Acknowledgements

The authors would like to thank the following Pfizer Inc. colleagues: Robert Donald, Natalie Silmon de Monerri, Jessica Atwell, and Yasmeen Agosti for critical review of the manuscript and Katheryn Liby for assistance in the graphics preparation. The authors also thank Nataliya Kushnir, Pfizer Inc. for scientific writing assistance.

Disclosure statement

The authors are employees of Pfizer Inc. at time of writing and may own Pfizer stock.

Additional information

Funding

The development of this manuscript was supported by Pfizer Inc.