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A Novel Hexavalent Capsular Polysaccharide Conjugate Vaccine (GBS6) for the Prevention of Neonatal Group B Streptococcal Infections by Maternal Immunization.

ABSTRACT: BACKGROUND:Group B streptococcus (GBS) causes serious diseases in newborn infants, often resulting in lifelong neurologic impairments or death. Prophylactic vaccination of pregnant women prior to delivery could provide comprehensive protection, as early onset and late-onset disease and maternal complications potentially could be addressed. METHODS:Capsular polysaccharide conjugate vaccine GBS6 was designed using surveillance data yielded by whole-genome sequencing of a global collection of recently recovered GBS isolates responsible for invasive neonatal GBS disease. Capsular polysaccharides were isolated, oxidized using sodium periodate, and conjugated to CRM197 by reductive amination in dimethyl sulfoxide. Immune responses in mice and rhesus macaques were measured in a multiplex Luminex immunoglobulin G (IgG) assay and opsonophagocytic activity assays. RESULTS:The optimized conjugates were immunogenic, alone and in combination, in mice and rhesus macaques, inducing IgG antibodies that mediated opsonophagocytic killing. Active immunization of murine dams with GBS6 prior to mating resulted in serotype-specific protection of pups from a lethal challenge with GBS. Protection following passive administration of serotype-specific IgG monoclonal antibodies to dams demonstrated conclusively that anticapsular polysaccharide IgG alone is sufficient for protection. CONCLUSIONS:The findings support the ongoing clinical evaluation of maternal GBS6 vaccination as a potential alternative method to prevent GBS disease in infants.

SUBMITTER: Buurman ET

PROVIDER: S-EPMC6548902 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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A Novel Hexavalent Capsular Polysaccharide Conjugate Vaccine (GBS6) for the Prevention of Neonatal Group B Streptococcal Infections by Maternal Immunization.

Buurman Ed T ET Timofeyeva Yekaterina Y Gu Jianxin J Kim Jin-Hwan JH Kodali Srinivas S Liu Yongdong Y Mininni Terri T Moghazeh Soraya S Pavliakova Danka D Singer Christine C Singh Suddham S Handke Luke D LD Lotvin Jason J Prasad A Krishna AK Scully Ingrid L IL Donald Robert G K RGK Jansen Kathrin U KU Anderson Annaliesa S AS

The Journal of infectious diseases 20190601 1

<h4>Background</h4>Group B streptococcus (GBS) causes serious diseases in newborn infants, often resulting in lifelong neurologic impairments or death. Prophylactic vaccination of pregnant women prior to delivery could provide comprehensive protection, as early onset and late-onset disease and maternal complications potentially could be addressed.<h4>Methods</h4>Capsular polysaccharide conjugate vaccine GBS6 was designed using surveillance data yielded by whole-genome sequencing of a global coll ...[more]

PMID: 30778554

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Project description:BackgroundThe incidence of chorioamnionitis occurs in between eight and 12 women for every 1000 live births and 96% of cases of chorioamnionitis are due to ascending infection. Following spontaneous vaginal delivery, 1% to 4% of women develop postpartum endometritis. The incidence of neonatal sepsis is 0.5% to 1% of all infants born. Maternal vaginal bacteria are the main agents for these infections. It is reasonable to speculate that prevention of maternal and neonatal infections might be possible by washing the vagina and cervix with an antibacterial agent for all women during labour. Chlorhexidine belongs to the class of compounds known as the bis-biguanides. Chlorhexidine has antibacterial action against a wide range of aerobic and anaerobic bacteria, including those implicated in peripartal infections.ObjectivesTo evaluate the effectiveness and side effects of chlorhexidine vaginal douching during labour in reducing maternal and neonatal infections (excluding group B streptococcal and HIV).Search methodsWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2014), reference lists of retrieved reports and journal letters and editorials.Selection criteriaRandomized or quasi-randomized trials comparing chlorhexidine vaginal douching during labour with placebo or other vaginal disinfectant to prevent (reduce) maternal and neonatal infections (excluding group B streptococcal and HIV).Data collection and analysisTwo review authors independently assessed trial eligibility and quality, extracted and interpreted the data. A third review author analyzed and interpreted the data. The fourth author also interpreted the data.Main resultsWe included three studies (3012 participants). There was no evidence of an effect of vaginal chlorhexidine during labour in preventing maternal and neonatal infections. Although the data suggest a trend in reducing postpartum endometritis, the difference was not statistically significant (three trials, 3012 women, risk ratio 0.83; 95% confidence interval 0.61 to 1.13).Assessment of the quality of the evidence using GRADE indicated that the levels of evidence for all primary outcomes and one important secondary outcome were low to moderate.Authors' conclusionsThere is no evidence to support the use of vaginal chlorhexidine during labour in preventing maternal and neonatal infections. There is a need for a well-designed randomized controlled trial using appropriate concentration and volume of vaginal chlorhexidine irrigation solution and with adequate sample size.

Dataset Information

A Novel Hexavalent Capsular Polysaccharide Conjugate Vaccine (GBS6) for the Prevention of Neonatal Group B Streptococcal Infections by Maternal Immunization.

Publications

A Novel Hexavalent Capsular Polysaccharide Conjugate Vaccine (GBS6) for the Prevention of Neonatal Group B Streptococcal Infections by Maternal Immunization.

Similar Datasets

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