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Updated: Jul 23, 2025
A Murine Model of Group B Streptococcus Vaginal Colonization
Published on: November 16, 2016
Potential for Maternally Administered Vaccine for Infant Group B Streptococcus
Shabir A Madhi1, Annaliesa S Anderson1, Judith Absalon1
1From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., R. Strehlau, A.I., G.K., S.J., L.J.), the Department of Paediatrics and Child Health, Faculty of Health Sciences, Rahima Moosa Mother and Child Hospital (R. Strehlau), and Wits RHI, Faculty of Health Sciences, University of the Witwatersrand (L.F.), Johannesburg, the Division of Neonatal Medicine, School of Child and Adolescent Health, Faculty of Health Sciences, University of Cape Town, and Mowbray Maternity Hospital, Cape Town (A.M.N.), the Clinical Neonatology Unit, Prince Mshiyeni Memorial Hospital (N.N.), and the Department of Medical Microbiology, National Health Laboratory Services, Prince Mshiyeni Memorial Hospital and College of Health Sciences, University of KwaZulu-Natal (Y.R.), Durban, the University of Pretoria and the Tshwane Academic Division, National Health Laboratory Services, Pretoria (M.S.), and the Family Center for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch (S.L.B.) - all in South Africa; and Vaccine Research and Development, Pfizer, Pearl River, NY (A.S.A., J.A., D.R., R. Simon, B.J., R.N., S.M., Z.J., D.P., N.C.S.M., E.G., J.L.P., D.A.S., W.C.G., K.U.J.).
A new maternal vaccine, GBS6, shows promise in preventing invasive group B streptococcal disease in infants. The vaccine elicits protective anti-capsular polysaccharide IgG antibodies in mothers, which are transferred to newborns, reducing disease risk.
Area of Science:
- Obstetrics and Gynecology
- Pediatrics
- Immunology
Background:
- Natural history studies link anti-capsular polysaccharide (CPS) IgG in newborns to decreased risk of group B streptococcal (GBS) disease.
- A hexavalent CPS-cross-reactive material 197 glycoconjugate vaccine (GBS6) is under development as a maternal vaccine.
Purpose of the Study:
- To assess the safety and immunogenicity of GBS6 in pregnant women.
- To analyze maternally transferred anti-CPS antibodies in infants.
- To define protective antibody thresholds against invasive GBS disease in newborns.
Main Methods:
- Phase 2, placebo-controlled trial of GBS6 in pregnant women.
- Parallel seroepidemiologic study to correlate anti-CPS IgG with reduced GBS disease risk in infants.
- Assessment of safety, immunogenicity, and maternal-to-infant antibody transfer.
Main Results:
- Naturally acquired anti-CPS IgG concentrations correlated with reduced infant GBS disease risk.
- Putative protective IgG thresholds identified (0.184–0.827 μg/mL for 75–95% risk reduction).
- GBS6 was safe; no significant safety signals observed in mothers or infants. GBS6 induced maternal responses, with antibody transfer to infants (ratios 0.4–1.3).
Conclusions:
- GBS6 vaccination in pregnant women elicits anti-GBS antibodies.
- These antibodies transfer to infants, achieving levels associated with reduced invasive GBS disease risk.
- The study supports GBS6 as a potential maternal vaccine for infant GBS disease prevention.
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