# Development of a bioconjugate vaccine against Group B Streptococcus

> **NIH NIH R41** · VAXNEWMO, LLC · 2020 · $280,104

## Abstract

PROJECT SUMMARY
Streptococcus agalactiae, commonly referred to as Group B Streptococcus (GBS), is a leading cause of neonatal
meningitis and sepsis worldwide as well as an agent of invasive disease in both pregnant and non-pregnant
adults. GBS neonatal disease manifests as early onset, defined as disease within the first six days after birth, or
late onset, defined as disease occurring after the first week of life; both of which are life threatening. In some
instances, early onset disease is preventable with intrapartum antibiotic prophylaxis; however, this treatment
strategy is not practical for low- and middle-income countries nor does it prevent late onset disease or the ~3.5
million preterm and 60,000 stillbirths attributed to GBS each year. Molecularly, GBS produces one of ten different
capsular polysaccharides, five of which (serotype Ia, Ib, II, III, and V) are associated with 97% of all invasive
neonatal GBS disease events. In addition, previous studies have demonstrated that placental transfer of
maternal antibodies are able protect neonates from invasive GBS infection. Therefore, a vaccine targeting these
five serotypes is of high societal and commercial value. In order to make an efficacious vaccine targeting GBS
capsules, the polysaccharide must be covalently linked to an immunogenic carrier protein generating what’s
termed a conjugate vaccine. Conjugate vaccines are considered some of the most effective vaccines to date, as
they are highly protective and generate immunological memory across all age groups. However, their synthesis
is complex, costly, and not conducive for all polysaccharides, which has hindered development of novel
conjugate vaccines against life threatening bacteria like GBS. As an alternative manufacturing platform,
VaxNewMo is developing conjugate vaccines using an innovative in vivo conjugation technology, which
eliminates the dependency on intricate chemical conjugation methods currently employed to synthesize these
vaccines. Using VaxNewMo’s proprietary bioconjugating enzyme technology, we will therefore generate the most
broadly covering GBS vaccine against five of the most prevalent GBS serotypes causing 97% of all neonatal
invasive disease events. The proposed research in this phase I application will focus on (Aim 1) developing five
glycoengineered strains of E. coli for the scalable, recombinant expression of GBS capsular polysaccharides in
conjunction with VaxNewMo’s conjugating enzyme technology, generating the first bioconjugate vaccine against
GBS. Subsequently (Aim 2) we will demonstrate that a monovalent GBS bioconjugate vaccine is
immunogenically non-inferior to a traditionally prepared chemical GBS conjugate vaccine. We will also
demonstrate the versatility of VaxNewMo’s bioconjugating platform by providing preliminary immunogenicity data
on a pentavalent GBS bioconjugate. Last, we will test for correlates of immunity by determining bacterial burden
and/or survival of newborn pups infected with GBS...

## Key facts

- **NIH application ID:** 9890994
- **Project number:** 5R41AI142928-02
- **Recipient organization:** VAXNEWMO, LLC
- **Principal Investigator:** Mario Feldman
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $280,104
- **Award type:** 5
- **Project period:** 2019-03-12 → 2021-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9890994

## Citation

> US National Institutes of Health, RePORTER application 9890994, Development of a bioconjugate vaccine against Group B Streptococcus (5R41AI142928-02). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/9890994. Licensed CC0.

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