{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T07:30:52Z","timestamp":1792740652122,"version":"4.5.0"},"reference-count":53,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2025,9,5]],"date-time":"2025-09-05T00:00:00Z","timestamp":1757030400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Gates Foundation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background\/Objectives: Group B Streptococcus (GBS) is a significant cause of perinatal infection in neonates and infants. Complications could include neonatal sepsis and meningitis, preterm birth, stillbirth, or death. Though no GBS vaccine is currently licensed, maternal immunization is expected to be a highly effective strategy to address invasive GBS disease\u2014particularly in low- and middle-income countries (LMICs), where the disease burden is the greatest and access to existing interventions is limited. In this study, we present a novel hexavalent GBS vaccine candidate with a unique combination of serotypes (ST)\u2014Ia, Ib, II, III, V, and VII\u2014that could be an efficacious and cost-effective intervention, with the broadest coverage of 99% against circulating serotypes globally. Methods: The 6-valent conjugate vaccine candidate, GBS-06, is developed using a novel approach by linking the six polysaccharides (PS) to recombinant cross-reactive material 197 (rCRM197) carrier protein derivatized with a hydrazide-polyethylene glycol-hydrazide (HZ-PEG-HZ) linker. A repeat-dose GLP toxicology study with GBS-06 was conducted at the highest clinical dose of 20 \u00b5g in rabbits with saline as the placebo control. Results: The results reveal induction of robust anti-capsular polysaccharide-specific IgG responses against each of the six serotypes after each dose with the highest antibody GMCs at Day 49 following the third dose. Conclusions: Hence, this work is the first demonstration of strong immunogenicity achieved using a linker (HZ-PEG-HZ) for GBS glycoconjugate vaccine development. The positive data from the study have strong implications in the advancement of the candidate for evaluation in clinical trials and provide a licensure pathway for maternal immunization.<\/jats:p>","DOI":"10.3390\/vaccines13090952","type":"journal-article","created":{"date-parts":[[2025,9,5]],"date-time":"2025-09-05T14:53:01Z","timestamp":1757083981000},"page":"952","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Preclinical Immunogenicity of a 6-Valent GBS Glycoconjugate Vaccine from a Repeat-Dose GLP Toxicology Study"],"prefix":"10.3390","volume":"13","author":[{"given":"Aakriti","family":"Bajracharya","sequence":"first","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gowri","family":"Chellappan","sequence":"additional","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florence","family":"Seal","sequence":"additional","affiliation":[{"name":"Immunology, Manufacturing Sciences and Technology, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutai","family":"Zhao","sequence":"additional","affiliation":[{"name":"Immunology, Manufacturing Sciences and Technology, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giriraj","family":"Chalke","sequence":"additional","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neza","family":"Chowdhury","sequence":"additional","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harshita","family":"Seth","sequence":"additional","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jen","family":"Gan","sequence":"additional","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shangdong","family":"Guo","sequence":"additional","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Pinder","sequence":"additional","affiliation":[{"name":"Immunology, Manufacturing Sciences and Technology, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fong","family":"Chang","sequence":"additional","affiliation":[{"name":"Immunology, Manufacturing Sciences and Technology, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Drew","family":"Huff","sequence":"additional","affiliation":[{"name":"Immunology, Manufacturing Sciences and Technology, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-2954-1177","authenticated-orcid":false,"given":"Abby","family":"Mydland","sequence":"additional","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chloe","family":"Wright","sequence":"additional","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lais","family":"Conceicao","sequence":"additional","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Winston","family":"Balasundaram","sequence":"additional","affiliation":[{"name":"Quality Control\/Micro, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rama","family":"Raghunandan","sequence":"additional","affiliation":[{"name":"Center for Vaccine Innovation and Access (CVIA), Program for Appropriate Technology in Health (PATH), Seattle, WA 98103, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anup","family":"Datta","sequence":"additional","affiliation":[{"name":"Bacterial Research and Development, Inventprise, Inc., Redmond, WA 98052, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Subhash 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