Serocorrelates of protection against infant group B streptococcus disease

Doare, Kirsty Le; Kampmann, Beate; Vekemans, Johan; Heath, Paul T; Green, David; Nahm, Moon H.; Baker, Carol J.; Edwards, Morven S.; Kwatra, Gaurav; Andrews, Nick; Madhi, Shabir А.; Meulen, Ajoke Sobanjo ter; Anderson, Annaliesa S.; Corsaro, Bart; Fischer, Per; Gorringe, Andrew

doi:10.1016/s1473-3099(18)30659-5

Cited by 57 publications

(43 citation statements)

References 71 publications

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“…The distribution of serotypes responsible for early and late -onset GBS disease also varies, with the most common serotypes being III and Ia (206). Correlates of protection for the different GBS serotypes against the various clinical conditions associated with the pathogen (i.e., colonization, maternal and infant disease) are not precisely defined (207), and these correlates may vary by serotype (207). Furthermore, transplacental transfer of antibodies might be affected by the characteristics of the vaccine (conjugated vs. unconjugated), the carrier protein used for conjugation, and the presence of underlying diseases in the mother which can reduce transfer, such as HIV infection (208).…”

Section: Group B Streptococcus Vaccinesmentioning

confidence: 99%

Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement

et al. 2020

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Section: Group B Streptococcus Vaccinesmentioning

confidence: 99%

Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement

et al. 2020

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“…[62][63][64][65] A review undertaken in 2019 synthesised the scientific evidence to define a serocorrelate of protection against GBS disease based on studies of natural infection. 66 In such a scenario, a phase IV study will be required post-licensure to assess effectiveness. This is the same approach used for meningococcal B vaccine licensure in the United Kingdom.…”

Section: Serocorrelates Of Protectionmentioning

confidence: 99%

“…49 There has been much debate about the methods of CPS-binding, for example that used in pneumococcal assays (poly-L-lycine) or the novel biotinstreptavidin methods. 66,68,69 The biotinylated method has the advantage of being able to use mass spectroscopy to determine the exact binding site of the biotin to the CPS, enabling the monitoring of any potential conformational changes to the CPS. 69 However, whether this affects the performance of the assay is unknown.…”

Section: Assays For Antibody Quantification and Evaluationmentioning

confidence: 99%

“…The GASTON consortium was recently set up with this aim. 66 On the other hand, efforts to identify common proteins to all GBS strains have been made in order to find a vaccine that confers protection against all GBS serotypes. Recent use of molecular techniques, such as multilocus sequence type (MLST) and whole-genome sequencing (WGS), have allowed us to better characterise the GBS structure, as well as to identify the virulent lineages such as ST17 hypervirulent strain, strongly associated with serotype III.…”

Section: Protein Vaccinesmentioning

confidence: 99%

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<p>A Vaccine Against Group B <em>Streptococcus</em>: Recent Advances</p>

Carreras-Abad¹,

Ramkhelawon²,

Heath³

et al. 2020

IDR

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Group B streptococcus (GBS) causes a high burden of neonatal and infant disease globally. Implementing a vaccine for pregnant women is a promising strategy to prevent neonatal and infant GBS disease and has been identified as a priority by the World Health Organisation (WHO). GBS serotype-specific polysaccharideprotein conjugate vaccines are at advanced stages of development, but a large number of participants would be required to undertake Phase III clinical efficacy trials. Efforts are therefore currently focused on establishing serocorrelates of protection in natural immunity studies as an alternative pathway for licensure of a GBS vaccine, followed by Phase IV studies to evaluate safety and effectiveness. Protein vaccines are in earlier stages of development but are highly promising as they might confer protection irrespective of serotype. Further epidemiological, immunological and health economic studies are required to enable the vaccine to reach its target population as soon as possible.

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“…Therefore, in order to facilitate the licensure of a vaccine, the study of protective serocorrelates, followed by a demonstration of a post-license efficacy, aroused interest. Although previous studies have shown an association between serotype-specific maternal IgG titers and reduction of neonatal disease risk, no study has been able to establish with certainty a protective antibody threshold value, due to different assays for determining antibody titers or inability to compare and pool the results of different studies [ 12 ]. Vaccines have been tested against serotype-specific capsular polysaccharide and against surface proteins that are expressed in different serotypes and could then protect against specific serotypes [ 7 , 12 ].…”

Section: Main Textmentioning

confidence: 99%

The Italian arm of the PREPARE study: an international project to evaluate and license a maternal vaccine against group B streptococcus

et al. 2020

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Background Group B streptococcus (GBS) is a leading cause of sepsis, pneumonia and meningitis in infants, with long term neurodevelopmental sequelae. GBS may be associated with poor pregnancy outcomes, including spontaneous abortion, stillbirth and preterm birth. Intrapartum antibiotic prophylaxis (IAP) is currently the only way to prevent early-onset disease (presenting at 0 to 6 days of life), although it has no impact on the disease presenting over 6 days of life and its implementation is challenging in resource poor countries. A maternal vaccine against GBS could reduce all GBS manifestations as well as improve pregnancy outcomes, even in low-income countries. Main body The term “PREPARE” designates an international project aimed at developing a maternal vaccination platform to test vaccines against neonatal GBS infections by maternal immunization. It is a non-profit, multi-center, interventional and experimental study (promoted by the St George University of London. [UK]) with the aim of developing a maternal vaccination platform, determining pregnancy outcomes, and defining the extent of GBS infections in children and mothers in Africa. PREPARE also aims to estimate the protective serocorrelates against the main GBS serotypes that cause diseases in Europe and Africa and to conduct two trials on candidate GBS vaccines. PREPARE consists of 6 work packages. In four European countries (Italy, UK, Netherlands, France) the recruitment of cases and controls will start in 2020 and will end in 2022. The Italian PREPARE network includes 41 centers. The Italian network aims to collect: GBS isolates from infants with invasive disease, maternal and neonatal sera (cases); cord sera and GBS strains from colonized mothers whose infants do not develop GBS infection (controls). Short conclusion PREPARE will contribute information on protective serocorrelates against the main GBS serotypes that cause diseases in Europe and Africa. The vaccine that will be tested by the PREPARE study could be an effective strategy to prevent GBS disease.

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Serocorrelates of protection against infant group B streptococcus disease

Cited by 57 publications

References 71 publications

Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement

Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement

<p>A Vaccine Against Group B <em>Streptococcus</em>: Recent Advances</p>

The Italian arm of the PREPARE study: an international project to evaluate and license a maternal vaccine against group B streptococcus

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