Maternal Group B Streptococcus Research Articles

Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides

ABSTRACT Measurement of IgG antibodies against group B streptococcus (GBS) capsular polysaccharide (CPS) by use of a standardized and internationally accepted multiplex immunoassay is important for the evaluation of candidate maternal GBS vaccines in order to compare results across studies. A standardized assay is also required if serocorrelates of protection against invasive GBS disease are to be established in infant sera for the six predominant GBS serotypes since it would permit the comparison of results across the six serotypes. We undertook an interlaboratory study across five laboratories that used standardized assay reagents and protocols with a panel of 44 human sera to measure IgG antibodies against GBS CPS serotypes Ia, Ib, II, III, IV, and V. The within-laboratory intermediate precision, which included factors like the lot of coated beads, laboratory analyst, and day, was generally below 20% relative standard deviation (RSD) for all six serotypes, across all five laboratories. The cross-laboratory reproducibility was < 25% RSD for all six serotypes, which demonstrated the consistency of results across the different laboratories. Additionally, anti-CPS IgG concentrations for the 44-member human serum panel were established. The results of this study showed assay robustness and that the resultant anti-CPS IgG concentrations were reproducible across laboratories for the six GBS CPS serotypes when the standardized assay was used.

Maternal GBS vaccination for preventing group B streptococcus disease in newborns: A mini review of current evidence.

Group B streptococcus (GBS) poses a significant threat to neonates, leading to morbidity and mortality. Intrapartum antibiotics, although effective, have limitations, prompting the exploration of maternal vaccination. This study reviews the current evidence for maternal GBS vaccination in the prevention of early-onset GBS disease in newborns. A search on Google Scholar, PubMed, and Scopus identified studies assessing the impact of maternal GBS vaccination on early-onset GBS disease. Inclusion criteria comprised English-language clinical trials or observational studies. Data extraction included study details, immunogenicity profiles, effectiveness, safety outcomes, and relevant findings. Qualitative synthesis was employed for data analysis. Five studies meeting the inclusion criteria were reviewed. Maternal GBS vaccines demonstrated efficacy with sustained immunogenicity. Adverse events, although documented, were predominantly non-severe. Variability in immune responses and maternal-to-infant antibody ratios show the need for tailored vaccination approaches. Long-term follow up and surveillance are essential to assess persistence and identify unintended effects. Positive outcomes in vaccine efficacy support GBS vaccination integration into maternal health programs. Implementation challenges in diverse healthcare infrastructures require tailored approaches, especially in resource-limited settings. Overcoming cultural barriers and ensuring healthcare provider awareness are crucial for successful vaccination.

Antimicrobial Resistance Profile of Group B Streptococci Colonization in a Sample Population of Pregnant Women from Romania.

Group B Streptococcus (GBS) represents one of the leading causes of life-threatening invasive disease in pregnant women and neonates. Rates of GBS colonization vary by region, but studies on maternal GBS status are limited in Romania. This study aims to identify the prevalence of colonization with GBS and whether the obstetrical characteristics are statistically associated with the study group's antimicrobial susceptibility patterns of tested GBS strains. This observational study was conducted between 1 May and 31 December 2021 at The Department of Obstetrics and Gynecology at Elias University Emergency Hospital (EUEH) in Bucharest, Romania. A total of 152 samples were positive for GBS and included in the study according to the inclusion criteria. As a result, the prevalence of colonized patients with GBS was 17.3%. GBS isolated in this population had the highest resistance to erythromycin (n = 38; 25%), followed by clindamycin (n = 36; 23.7%). Regarding the susceptibility patterns of tested strains to penicillin, the 152 susceptible strains had MIC breakpoints less than 0.06 μg/μL. The susceptibility patterns of tested strains to linezolid indicated three resistant strains with low levels of resistance (MICs ranging between 2 and 3 μg/μL). Multidrug resistance (at least three antibiotic classes) was not observed. In conclusion, although GBS naturally displays sensitivity to penicillin, the exact bacterial susceptibility testing should be performed in all cases where second-line therapy is taken into consideration for treatment. We acknowledge the need for future actions to limit multidrug-resistant bacteria.

“Why has this new vaccine come and for what reasons?” key antecedents and questions for acceptance of a future maternal GBS vaccine: Perspectives of pregnant women, lactating women, and community members in Kenya

ABSTRACT Group B streptococcus (GBS) is a leading global cause of neonatal sepsis and meningitis, stillbirth, and puerperal sepsis. While intrapartum antibiotic prophylaxis (IAP) is a currently available GBS disease prevention strategy, IAP is programmatically complex to implement, precluding use in low- and middle-income countries. In Kenya, 2% of stillbirths are attributable to GBS infection. Two maternal GBS vaccines are in late-stage clinical development. However, licensure of a maternal GBS vaccine does not translate into reduction of disease. We conducted 28 in-depth interviews with pregnant people, lactating people, and community members across two counties in Kenya to better understand the attitudes and informational needs of primary vaccine beneficiaries. We identified two emerging themes from the data. The first focused on antecedents to maternal GBS vaccine acceptability. The most common antecedents focused on the vaccine’s ability to protect the baby and/or the mother, followed by community sensitization before the vaccine was available. The second key theme focused on questions that would need to be addressed before someone could accept a maternal GBS vaccine. Three key categories of questions were identified, including vaccine safety compared to vaccine benefits, who gets the vaccine, and how the vaccine works. Realizing the potential benefits of a future GBS maternal vaccine will require a multifactorial approach, including ensuring that communities are aware of GBS-related harms as well as the safety and effectiveness of a maternal GBS vaccine. Our study contributes to informing this multifactorial approach by elucidating the attitudes and concerns of key populations.

The current status of Group B Streptococcus infection in the reproductive tract of late-pregnancy women and its impact on pregnancy outcomes.

Analyze Group B Streptococcus (GBS) infection in late-pregnancy pregnant women in Shanghai, the risk factors of GBS infection, and its impact on pregnancy outcomes, providing guidance for early prevention and treatment in clinical practice. We selected 12,132 late-pregnancy pregnant women admitted from January 2022 to December 2022 as the research subjects. Based on the GBS test results of reproductive tract secretion samples from pregnant women, 210 cases of GBS positive pregnant women were randomly selected as the observation group, and 200 cases of GBS negative pregnant women were selected as the control group. The risk factors of infection and the impact on pregnancy outcomes were compared between the two groups. The GBS colonization rate of pregnant women in this study was 6.52%; the incidence of Vaginal delivery and Neonatal infection in GBS positive group was significantly higher than that in GBS negative group (P < 0.05); with Neonatal infection as the dependent variable, and the GBS infection, Vaginal delivery and GDM of the elderly and women in late pregnancy as independent variables, the results showed that GBS infection of women in late pregnancy was an independent risk factor for Neonatal infection. Clinical practice should attach great importance to GBS infection in late pregnancy, strengthen GBS screening in late pregnancy, and actively implement the strategy of intrapartum antibiotic intervention (IAP), which is of great significance in reducing the vertical infection rate of maternal and infant GBS and improving the quality of newborn birth.

Group B Streptococcus and Perinatality in the South of Tunisia: Epidemiology, Serotype Distribution, and Antibiotic Susceptibility

IntroductionIn the lack of updated Tunisian epidemiological data, we sought to describe the epidemiology of Group B Streptococcus (GBS) in pregnant women and newborns.Materials and methodsA retrospective analysis of GBS neonatal invasive infections and a cross-sectional study evaluating the prevalence of maternal GBS colonization were conducted. GBS isolates were tested for antimicrobial susceptibility, serotyped, and assessed for the appurtenance to the hypervirulent ST17 clone.ResultsOf 98 neonates with GBS, early-onset GBS disease (EOD) comprised 83.7 and 16.3% were late-onset GBS disease (LOD). The prevalence of maternal GBS colonization was 27%. All GBS isolates were susceptible to penicillin. Serotype III predominated (42.6%) for neonatal invasive infections. GBS isolates belonging to the ST17 sequence type were found only as serotype III.ConclusionThis study documents the frequency of GBS EOD, the high rate of maternal GBS colonization, and the predominance of the hypervirulent clone type III/ST17 in infants.

Group B Streptococcal Disease in Infants in Japan.

This review describes the epidemiology of group B Streptococcus (GBS) infection in infants in Japan and discusses unresolved issues and future perspectives. Guidelines for the prevention of vertical transmission in Japan were implemented in 2008. The incidence of early-onset disease in Japan has remained stable at approximately 0.10/1000 livebirths or less, which is lower than in Europe and North America. The incidence of late-onset disease is also low, but has increased over the last decade, with an estimated 0.29/1000 livebirths in 2020. National surveillance studies in 2011-2015 and 2016-2020 reported case fatality rates of 4.5% and 6.5% for early-onset disease and 4.4% and 3.0% for late-onset disease, respectively. Sequelae of neurodevelopmental impairments were considerably associated with infants who developed meningitis. Predominant neonatal invasive strains have remained in the following order of serotypes: III, Ia, Ib and V, for the past 30 years. Conversely, the predominant serotypes of maternal colonization strains markedly changed from serotypes VI and VIII around 2000 to serotypes Ia, Ib, III and V over the last decade. Recurrence rates among infants < 1-year-old were estimated to be 2.8%-3.7%, and preterm birth and antenatal maternal GBS colonization were risk factors for recurrence. Several unresolved issues remain. First, the exact disease burden remains unclear because Japan does not have a nationwide system to register all infants affected by invasive GBS disease, and even population-based surveys are limited to up to 10 of the 47 prefectures. Others include low adherence to prevention guidelines of vertical transmission and the development of strategies based on Japanese epidemiological evidence rather than the Center for Disease Control and Prevention guidelines. The effectiveness of introducing maternal vaccines in Japan, where the disease incidence is low, needs to be carefully verified.

Incidence of group B streptococcus early-onset sepsis in term neonates with second-line prophylaxis maternal intrapartum antibiotics: a multicenter retrospective study

BackgroundThe difference in incidence of early onset sepsis (EOS) caused by Group B Streptococcus (GBS) among term neonates whose mothers receive first versus second-line intrapartum prophylaxis is poorly described. ObjectiveTo compare the incidence of GBS EOS in term neonates born to mothers who receive first, second-line or no intrapartum antibiotics, and describe the short term and survival outcomes of neonates who developed GBS EOS stratified by maternal antepartum prophylaxis. Study DesignThis was a retrospective review of electronic medical records. We queried the Pediatrix Medical Group Clinical Data Warehouse to evaluate the outcomes of term neonates born to GBS positive mothers between 2003 – 2020, and compared the incidence and outcomes of neonates with GBS EOS whose mothers received first versus second-line/no intrapartum prophylaxis. ResultsAmong 496,180 neonates, 104,196 (21%) were born to GBS positive mothers. Out of 97,983 GBS positive mothers with adequate prenatal antibiotic documentation, 49,234 (50%), 12,679 (13%) and 36,070 (37%) received first-line, second-line and no intrapartum prophylaxis, respectively. Incidence of GBS EOS among all neonates with maternal GBS carriage was 0.22% (231/104,196). Neonates whose mothers received second-line intrapartum antibiotics and no antibiotics had higher risk of GBS EOS infection compared to first-line intrapartum antibiotics [adjusted odds ratio (aOR) 4.12, 95% confidence interval (CI): 2.66 – 6.38 and aOR 3.80, 95% CI: 2.66 – 5.44, respectively]. No statistically significant difference in the risk of GBS EOS in neonates born to mothers who received second-line versus no antibiotics (aOR 0.92, 95% CI: 0.64 – 1.33). ConclusionNeonates exposed to second-line maternal GBS prophylaxis had increased risk of GBS EOS compared to those exposed to first-line maternal GBS prophylaxis. There was no statistically significant difference in GBS EOS incidence between second-line versus no antibiotics in mothers with GBS carriage.

Near-term pregnant women in the Dominican Republic experience high rates of Group B Streptococcus rectovaginal colonization with virulent strains.

Maternal colonization with Group B Streptococcus (GBS) is an important cause of stillbirth, prematurity, and serious infection and death in infants worldwide. Resource constraints limit prevention strategies in many regions. Maternal GBS vaccines in development could be a more accessible prevention strategy, but data on geographic variations in GBS clones are needed to guide development of a broadly effective vaccine. In the Dominican Republic (DR), limited data suggest that pregnant women experience GBS colonization at rates among the highest globally. We aimed to determine the prevalence of maternal rectovaginal GBS colonization and describe clonal characteristics of colonizing strains in the DR. A cross-sectional study assessed rectovaginal GBS colonization in 350 near-term pregnant women presenting for routine prenatal care at an urban tertiary center in the DR. Rectovaginal samples were tested with chromogenic Strep B Carrot Broth and cultured for confirmatory whole-genome sequencing. In a secondary analysis, participants' demographics and histories were assessed for association with GBS colonization. Rectovaginal GBS colonization occurred in 26.6% of women. Serotypes Ia, Ib, II, III, IV, and V were detected, with no one serotype predominating; serotype III was identified most frequently (21.5%). Virulent and emerging strains were common, including CC17 (15.1%) and ST1010 (17.2%). In this first characterization of maternal GBS serotypes in the DR, we found high rates of rectovaginal colonization including with virulent and emerging GBS strains. The serotypes observed here are all targeted by candidate hexavalent GBS vaccines, suggesting effective protection in the DR.

Association between glycemic control and group B streptococcus colonization among pregnant individuals with pregestational diabetes.

Pregestational diabetes increases the risk of group B streptococcus (GBS) colonization in pregnancy. Whether glycemic control is associated with differences in this risk is unknown. We examined the association between glycemic control and GBS colonization among pregnant individuals with pregestational diabetes. A retrospective cohort of pregnant individuals with pregestational diabetes at a tertiary care center. The exposure was glycemic control, measured as hemoglobin A1c (A1c) at >20weeks and assessed categorically at thresholds of <6.5% and <6.0%, and secondarily, as a continuous percentage. The outcome was maternal GBS colonization. Multivariable logistic regression was used and adjusted for age, parity, race, and ethnicity as a social determinant, body mass index, type of diabetes, and gestational age at A1c assessment. Among 305 individuals (33% Type 1, 67% type 2), 45.0% (n=140) were colonized with GBS. Individuals with an A1c<6.5% were half as likely to be colonized with GBS compared with those with a A1c≥6.5% (38.8% vs. 53.9%; adjusted odds ratio, AOR: 0.55; 95% CI: 0.33-0.91). Results were unchanged at an A1c threshold of <6.0% (35.7% vs. 48.5%; AOR: 0.60; 95% CI: 0.36-0.98). Individuals with a higher A1c as a continuous measure (%) were more likely to be colonized (AOR: 1.57 per 1%; 95% CI: 1.25-1.97). Pregnant individuals with pregestational diabetes with worse glycemic control were at an increased risk of GBS colonization. Further study is needed to understand if improved glycemic control leads to lower risk of GBS colonization.

Prevalence of group B streptococcus colonisation and pregnancy outcomes of pregnant women at Hanoi Obstetrics and Gynecology Hospital

Objectives: To determine the prevalence of maternal group B streptococcus (GBS) colonisation and pregnancy results of pregnant women at Hanoi Obstetrics and Gynecology Hospital. Materials and methods: Retrospective descriptive with 537 pregnant women delivered at the Hanoi Obstetrics and Gynecology Hospital in 2021, GBS was detected based on culture, isolation, and identification of bacteria from the vagina-rectum samples at 36-37+6 weeks gestation. Results: The prevalence of maternal GBS colonisation was 18.1%. 87.5% of GBS colonisations were applied to intrapartum antibiotic prophylaxis during labour or ruptured membranes. Diabetes increased the risk of carrying GBS (OR=2.3, 95%CI: 1.17-4.34). Maternal GBS colonisation increased the risk of rupture of membranes (OR 3.09, 95%CI: 1.95-4.85) and antibiotic treatment of newborns (OR=3.39, 95%CI: 1.05-10.92). However, there was no increased risk for cesarean section or postpartum infection (p&gt;0.05). Maternal GBS colonisation with intrapartum antibiotic prophylaxis has not increased the risk for early neonatal (OR=0.55, 95%CI: 0.06-5.44). Conclusion: The prevalence of maternal GBS colonisation was 18.1%. Pregnant women carrying GBS treated with intrapartum antibiotic prophylaxis did not increase the risk of maternal adverse pregnancy outcomes and early neonatal infection.

Early-onset group B streptococcal disease in African countries and maternal vaccination strategies.

Invasive group B streptococcal (GBS) disease is the commonest perinatally-acquired bacterial infection in newborns; the burden is higher in African countries where intrapartum antibiotic prophylaxis strategies are not feasible. In sub-Saharan Africa, almost one in four newborns with GBS early-onset disease will demise, and one in ten survivors have moderate or severe neurodevelopmental impairment. A maternal GBS vaccine to prevent invasive GBS disease in infancy is a pragmatic and cost-effective preventative strategy for Africa. Hexavalent polysaccharide protein conjugate and Alpha family surface protein vaccines are undergoing phase II clinical trials. Vaccine licensure may be facilitated by demonstrating safety and immunological correlates/thresholds suggestive of protection against invasive GBS disease. This will then be followed by phase IV effectiveness studies to assess the burden of GBS vaccine preventable disease, including the effect on all-cause neonatal infections, neonatal deaths and stillbirths.

Inferring longitudinal patterns of group B Streptococcus colonization during pregnancy

Maternal colonization by Group B Streptococcus (GBS) can lead to severe infection in neonates and has also been associated with prematurity and stillbirth. Better quantitative understanding of the trajectories of GBS carriage during pregnancy is essential for the design of informative epidemiological studies. Here, we describe analyses of published longitudinal data using Bayesian hidden Markov models, which involve the estimation of parameters related to the succession of latent states (infection status) and observations (culture positivity). In addition to quantifying infection acquisition and clearance probabilities, the statistical approach also suggests that for some longitudinal patterns of culture results, pregnant women were likely to have been GBS-colonized despite a negative diagnostic result. We believe this method, if used in future longitudinal studies of maternal GBS colonization, would improve our understanding of the pathologies linked to this bacterium and could also inform maternal GBS vaccine trial design.

Self-collected versus health-care professional taken swab for identification of vaginal-rectal colonisation with group B streptococcus in late pregnancy: a systematic review

BackgroundTesting for group B streptococcus (GBS) requires a vaginal-rectal swab in late pregnancy. ObjectiveA systematic review of the test accuracy of a self-collected swab compared with a health-care professional collected swab in the diagnosis of GBS colonisation. Search strategyThe Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects [DARE] and the Cochrane Central Register of Controlled Trials [CENTRAL]), EMBASE, MEDLINE and Trip were searched in May 2022. Selection criteriaRandomised trials, test accuracy studies or diagnostic yield studies that compared the accuracy of a self-collected vaginal-rectal swab, compared to that taken by a health-care professional, for the detection of GBS colonisation in the third trimester. Data collection and analysisTwo researchers independently screened, selected studies, extracted data and assessed study quality. Main results10 studies, with 2578 women were included. Pooled sensitivity of self-collected swabs was 0.90 (95% confidence interval [CI] 0.81 to 0.95) and pooled specificity was 0.98 (95% CI 0.96 to 0.99). ConclusionThis study provides reassuring evidence that self-collected swabs for maternal GBS colonisation are highly accurate relative to swabs collected by health-care professionals. Women requiring a swab for GBS colonisation can self-swab with appropriate instructions if they choose. FundingPersonal fellowship from the University of Nottingham for KFW.

Population genetics of group B Streptococcus from maternal carriage in an ethnically diverse community in London.

Maternal immunization against Group B Streptococcus (GBS) has the potential to significantly reduce the burden of neonatal GBS infections. Population genetics of GBS from maternal carriage can offer key insights into vaccine target distribution. In this study we characterized the population structure of GBS isolates from maternal carriage (n = 535) in an ethnically diverse community in London, using whole genome sequencing. The isolates clustered into nine clonal complexes (CCs) but the majority (95%) belonged to five lineages: CC1 (26%), CC19 (26%), CC23 (20%), CC17 (13%) and CC8/10 (10%). Nine serotypes were identified, the most common were serotypes III (26%), V (21%), II (19%) and Ia (19%). Other serotypes (Ib, IV, VI, VII, IX) represented less than 10% of all isolates each. Intra-lineage serotype diversity was observed in all major CCs but was highest in CC1, which revealed nine serotypes. Nearly all isolates (99%) carried at least one of the four alpha family protein genes (alpha, alp1, alp23, and rib). All isolates were susceptible to penicillin. We found 21% and 13% of isolates to be resistant to clarithromycin and clindamycin, respectively. Prevalence of macrolide-lincosamide-streptogramin B (MLSB) resistance genes was 22% and they were most common in CC19 (37%) and CC1 (28%), and isolates with serotypes V (38%) and IV (32%). We identified some associations between maternal ethnicity and GBS population structure. Serotype Ib was significantly less common among the South Asian compared to Black women (S. Asian: 3/142, Black: 15/135, p = 0.03). There was also a significantly lower proportion of CC1 isolates among the White other (24/142) in comparison to Black (43/135) and S. Asian (44/142) women (p = 0.04). We found a significantly higher proportion of CC17 isolates among the White other compared to S. Asian women (White other: 32/142, S. Asian: 10/142, p = 0.004). Our study showed high prevalence of GBS vaccine targets among isolates from pregnant women in London. However, the observed serotype diversity in CC1 and high prevalence of MLSB resistance genes in CC19 demonstrates presence of high risk lineages, which might act as a reservoir of non-vaccine strains and antimicrobial resistance determinants.

Recent research on the epidemiology and preventive strategies of neonatal group B Streptococcus infection in the latest decade

Currently, the main strategy for preventing neonatal group B Streptococcus (GBS) infection is prenatal screening combined with intrapartum antibiotic prophylaxis, which has effectively reduced the incidence of neonatal GBS early-onset disease. However, the burden of GBS infection is still significant. The intrapartum antibiotic prophylaxis strategy has limitations such as inducing antibiotic resistance and inability to effectively prevent GBS late-onset disease. It is crucial to develop and evaluate other prevention strategies, while paying close attention to assessing penicillin allergy in pregnant women and how to prevent GBS infection in neonates with negative maternal GBS screening. In recent years, there has been some progress in GBS vaccines and related immunological research, and the use of specific vaccines is expected to significantly reduce GBS infection in neonates.

Risk Stratification to Support Antibiotic Stewardship and Breastfeeding Exclusivity in a Military Treatment Facility

ObjectiveTo safely reduce unnecessary antibiotic exposure in neonates exposed to chorioamnionitis and inadequately treated Group B Streptococcus (GBS) using the early-onset sepsis (EOS) calculator for risk stratification and a 36-hour antibiotic duration. DesignEvidence-based quality improvement initiative. Setting/Local ProblemObstetric service at a midsized military treatment facility with approximately 2,000 births annually and no standard process for neonatal EOS risk assessment. ParticipantsClinical nurse specialist, physicians, nursing leadership, unit-level nursing champions, and nurses assigned to the mother–baby and labor and delivery units. Intervention/MeasurementsAn interdisciplinary working group created a protocol to institute an EOS risk assessment calculator, a note for the electronic heath record, and interdisciplinary education for all staff providing care to neonates in our facility. ResultsBefore implementation of the EOS calculator, 97.6% of neonates exposed to chorioamnionitis or inadequate maternal GBS treatment received antibiotics; after implementation, the mean rate dropped to 32%. Exclusive breastfeeding rates before discharge in neonates exposed to chorioamnionitis or inadequate maternal GBS treatment also increased during this time, from 40% to a mean of 89%. After implementation, there were no readmissions to our institution for culture-proven sepsis within 14 days of discharge. ConclusionMultidisciplinary team-led implementation of the EOS calculator and of shortened antibiotic duration were associated with safely reduced antibiotic exposure in well-appearing neonates exposed to chorioamnionitis and GBS. In addition, dramatically improved rates of exclusive breastfeeding at discharge were observed in this population.

Maternal immunisation against Group B Streptococcus: A global analysis of health impact and cost-effectiveness.

Group B Streptococcus (GBS) can cause invasive disease (iGBS) in young infants, typically presenting as sepsis or meningitis, and is also associated with stillbirth and preterm birth. GBS vaccines are under development, but their potential health impact and cost-effectiveness have not been assessed globally. We assessed the health impact and value (using net monetary benefit (NMB), which measures both health and economic effects of vaccination into monetary units) of GBS maternal vaccination in an annual cohort of 140 million pregnant women across 183 countries in 2020. Our analysis uses a decision tree model, incorporating risks of GBS-related health outcomes from an existing Bayesian disease burden model. We extrapolated country-specific GBS-related healthcare costs using data from a previous systematic review and calculated quality-adjusted life years (QALYs) lost due to infant mortality and long-term disability. We assumed 80% vaccine efficacy against iGBS and stillbirth, following the WHO Preferred Product Characteristics, and coverage based on the proportion of pregnant women receiving at least 4 antenatal visits. One dose was assumed to cost $50 in high-income countries, $15 in upper-middle income countries, and $3.50 in low-/lower-middle-income countries. We estimated NMB using alternative normative assumptions that may be adopted by policymakers. Vaccinating pregnant women could avert 127,000 (95% uncertainty range 63,300 to 248,000) early-onset and 87,300 (38,100 to 209,000) late-onset infant iGBS cases, 31,100 deaths (14,400 to 66,400), 17,900 (6,380 to 49,900) cases of moderate and severe neurodevelopmental impairment, and 23,000 (10,000 to 56,400) stillbirths. A vaccine effective against GBS-associated prematurity might also avert 185,000 (13,500 to 407,000) preterm births. Globally, a 1-dose vaccine programme could cost $1.7 billion but save $385 million in healthcare costs. Estimated global NMB ranged from $1.1 billion ($-0.2 to 3.8 billion) under the least favourable normative assumptions to $17 billion ($9.1 to 31 billion) under the most favourable normative assumptions. The main limitation of our analysis was the scarcity of data to inform some of the model parameters such as those governing health-related quality of life and long-term costs from disability, and how these parameters may vary across country contexts. In this study, we found that maternal GBS vaccination could have a large impact on infant morbidity and mortality. Globally, a GBS maternal vaccine at reasonable prices is likely to be a cost-effective intervention.

Safety and immunogenicity of the group B streptococcus vaccine AlpN in a placebo-controlled double-blind phase 1 trial.

Group B streptococcus (GBS) is a leading cause of life-threatening neonatal infections and subsets of adverse pregnancy outcomes. Essentially all GBS strains possess one allele of the alpha-like protein (Alp) family. A maternal GBS vaccine, consisting of the fused N-terminal domains of the Alps αC and Rib (GBS-NN), was recently demonstrated to be safe and immunogenic in healthy adult women. To enhance antibody responses to all clinically relevant Alps, a second-generation vaccine has been developed (AlpN), also containing the N-terminal domain of Alp1 and the one shared by Alp2 and Alp3. In this study, the safety and immunogenicity of AlpN is assessed in a randomized, double-blind, placebo-controlled, and parallel-group phase I study, involving 60 healthy non-pregnant women. AlpN is well tolerated and elicits similarly robust and persistent antibody responses against all four Alp-N-terminal domains, resulting in enhanced opsonophagocytic killing of all Alp serotypes covered by the vaccine.

Vaginal Carriage of Group B Streptococcus (GBS) in Pregnant Women, Antibiotic Sensitivity and Associated Risk Factors in Dakar, Senegal.

The eradication of neonatal Group B Streptococcus (GBS) infections, considered as a major public health priority, necessarily requires a mastery of the data on vaginal carriage in pregnant women. The aims of this study were to determine the prevalence of vaginal carriage of GBS in pregnant women, antibiotic susceptibility, and associated risk factors. This was a cross-sectional, descriptive study conducted over a period of 9 months (July 2020 to March 2021) in pregnant women between 34 and 38 weeks of gestation (WG) followed at the Nabil Choucair health center in Dakar. Identification and antibiotic susceptibility of GBS isolates were performed on the Vitek 2 from vaginal swabs cultured on Granada medium. Demographic and obstetric interview data were collected and analyzed on SPSS (version 25). The level of significance for all statistical tests was set at P < .05. The search of GBS vaginal carriage had involved 279 women aged 16 to 46 years, with a median pregnancy age of 34 (34-37) weeks' gestation. GBS was found in 43 women, for a vaginal carriage rate of 15.4%. In 27.9% (12/43) of volunteers screened, this carriage was monomicrobial, while in 72.1% (31/43) of women, GBS was associated with other pathogens such as Candida spp. (60.5%), Trichomonas vaginalis (2.3%), Gardnerella vaginalis (34.9%) and/or Mobiluncus spp. (11.6%). The level of resistance was 27.9% (12/43) for penicillin G, 53.5% (23/43) for erythromycin, 25.6% (11/43) for clindamycin and 100% for tetracycline. However, the strains had retained fully susceptible to vancomycin and teicoplanin. The main risk factor associated with maternal GBS carriage were ectocervical inflammation associated with contact bleeding (OR = 3.55; P = .005). The high rate of maternal vaginal GBS carriage and the levels of resistance to the various antibiotics tested confirm the importance of continuous GBS surveillance in our resource-limited countries.